DDrare: Database of Drug Development for Rare Diseases

51. 全身性強皮症
［臨床試験数：466，薬物数：536（DrugBank：142），標的遺伝子数：110，標的パスウェイ数：210］

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0,5 mg Prevenar i.m.; 0,5 mg seasonal influenza vaccine i.m.; 0.9% sodium chloride; 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID; 1-22460; 10% Nitroglycerine in Propylene Glycol, USP; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; ABR-215757; ACHIM as solute (10^9 intestinal microbes/ml); ACT-064992; ACT-293987; ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADSVF application in the right hand; AIMSPRO; AL; AM-01; ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS; ASASANTIN Retard; ASC; AUC of MPA measure; AVID200; Abatacept; Abituzumab; Abituzumab 1500 mg; Abituzumab 500 mg; Acetaminophen; Acetate; Acetylcysteine; Acetylsalicylic acid; Acotiamide; Adempas; Administration of rituximab and methylprednisolone; Air; Ajulemic acid; Albumin; Alemtuzumab; Alginic acid; Allogeneic Mesenchymal Stem Cells (AlloMSC); Alpha-2C AR antagonist; Alprostadil; Ambrisentan; Amlodipine; Amlodipine Gel; Anaerobically Cultivated Human Intestinal Microbiota; Anaerobically Cultivated medium; Anti-CT51 antigen mAb; Anti-Thymocyte Globulin; Anti-Thymocyte Globulin, Rabbit; Anti-integrin alphaV mAb; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Asasantin Retard ®; Aspirin; Atorvastatin; Autologous ASC; Autologous Stem Cells; Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells; Aviptadil; BAY63-2521; BERMEKIMAB; BH4; BIBF 1120; BMS-986020; BOSENTAN MONOHYDRATE; BOTOX® solution; Beam; Belimumab; Belumosudil (KD025); Bermekimab; Biopsy; Blood coagulation factor XIII; Blood sample; Blood samples; Blood sampling; Bortezomib; Bosentan; Bosentan (Tracleer); Bosentan 125 mg; Bosentan 62.5 mg; Bosentan group; Bosentan monohydrate; Botox; Botulinum Toxin Type B; Botulinum toxin A; Botulinum toxin type B (2500 units / vial); Botulinum toxin(Botox); Bovine type I collagen; Brentuximab; Brentuximab Vedotin; Brentuximab vedotin; Brodalumab; Bupivacaine; Buspirone; Busulfan; Butanoic acid; C-82 Topical Gel, 1%; C21; C225; CAM2043; CAPILLAREMA; CC; CC-4047; CD; CD34 selected autologous hematopoietic cells; CD34+SC; CILOSTAZOL; CYCLOPHOSPHAMIDE; Calcipotriene; Calcium; Calcium Channel Blockers; Campath; Carbon; Carbon dioxide; Cetuximab; Chloride; Cialis; Cilostazol; Clobetasol; Cuprimine (penicillamine); Currently available therapy in the community; Cutaneous iontophoresis of treprostinil; Cyclophosphamide; Cyclophosphamide Injection 1g; DI-17E6; DIGNA P144 CREAM; DIGNA P144 cream; Dabigatran; Dabigatran etexilate; Dasatinib; Depot leuprolide acetate 3.75 mg; Dersimelagon; Device: Air filled balloon catheter; Device: Fractional carbon dioxide laser; Device: Manual toothbrush; Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580; Device: Serial night time position splint; Device: Solid state catheter; Device: Sonic toothbrush; Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss); Device: Ultraviolet A1 phototherapy (UVA1); Device: the ozone generator device (Human Pro medic, German); Diagnostic Test: CMRI; Diagnostic Test: Imaging; Diagnostic Test: P-MPA concentration; Diagnostic Test: Pulmonary function test; Diltiazem; Diltiazem Gel 2%; Dimethyl Fumarate (DMF); Dimethyl fumarate; Diphenhydramine; Dipyridamole; Divalproex sodium; Domperidone; Double-Blind Rituximab; Drug treatment; Dupilumab; Dupilumab 300Mg Solution for Injection; EDTA; EMA/CHMP/212874/2015; EMD 525797; ENDOPROST; ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA; ENDOPROST 0,05MG/0,5ML 1F; ENDOPROST 50*INFUS 1F 0,050MG/; EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS; Endoprost; Endothelin receptor blocker; Erbitux; Esbriet; Ethanol; FILGRASTIM; FT011; Factor XIII; Fasudil; Fibrogammin® 1250; Fibrogammin®P, coagulation factor XIII concentrate (Human); Filgrastim; Fludarabine; Fludarabine phosphate; Fresolimumab; From August 2020 'no additional treatment'; G-CSF; G451990; GLIVEC; GLPG1690; GM-CSF; GS-248; GSK2330811; GSK2330811 Solution for Injection, 100mg/ml; Genetic: FCX-013; Glivec; Glivec 100 mg Filmtabletten; Glycyrrhizin; Gran; HIDONAC*EV 1FL 5G 25ML; HUMAN NORMAL IMMUNOGLOBULIN; Hematopoietic stem cell transplantation; High-dose intravenous immunoglobulin (Venoglobulin-IH); Hizentra; Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody; Human normal immunoglobulin; Human normal immunoglobulin for intravenous (IV) administration; Human normal immunoglobulin for intravenous administration; Human normal immunoglobulin for subcutaneous administration; Hyaluronidase; Hyaluronidase injected intradermally; Hyperimmune caprine serum; Hyperoxia; ILOPROST SALE DI TROMETAMOLO; ILOPROST TROMETAMOL; IMATINIB MESILATO; INCB039110; INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS; INTERLEUKIN 2; ITACITINIB; IV Cyclophosphamide; IVA337; IVIg; Ifetroban; IgPro10; IgPro20; Iguratimod; Ilomedin; Iloprost; Iloprost Injection, for intravenous use; Iloprost low dose; Iloprost therapy up to 2 ng/kg x min; Iloprost trometamol; Imatinib; Imatinib Mesylate; Imatinib mesylate; Imiquimod; Imiquimod 5% cream; Imnovid; Imnovid 1 mg hard capsules; Indocyanine Green; Indocyanine green; Indole; Influenza vaccine; Injection of autologous stromal vascular fraction; Interleukin 2; Intravenous immunoglobulin; Iontophoresis of treprostinil; Itacitinib; JBT-101; KHK4827; LANIFIBRANOR; LENABASUM; Lactobacillus; Lanifibranor; Lenabasum; Lenabasum 20 mg; Lenabasum 20 mg Powder in Capsule; Lenabasum 5 mg; Lenabasum 5 mg Powder in Capsule; Leuprolide; Lidocaine; Lidocaine 2% without vessel constrictor; Lipitor; Liposomal bupivacaine; MABp1 (Bermekimab); MEDI-546; MEDI-551; MESNA; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; METOCLOPRAMIDE; METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL; MHSCT; MMF; MPA; MQX-503; MSC; MT-7117; MabThera; Mabthera; Macitentan; Macitentan 10 mg; Macitentan 10mg; Macitentan 3 mg; Macitentan 3mg; Medrone; Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jelly; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesenchymal stromal cells; Mesna; Methotrexate; Methylprednisolon; Methylprednisolone; Methylprednisolone acetate; Metoclopramide; Metronidazole; Mg; Microgynon; Mizoribine; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF); Mycophenolate mofetil; Mycophenolic Acid; Mycophenolic acid; N-acetylcysteine (NAC); NAC; ND; NINTEDANIB; NON PROPIETRY, THEREFORE N/A; Neovasculgen; Neupogen; Nilotinib; Nilotinib (Tasigna); Nintedanib; Nitroglycerin; Nitroglycerin Ointment 2%; Nitroglycerine; Nitroglycerine gel; Nitroprusside; Nivolumab; Non applicabile; Null; ORENCIA; ORM-12471; ORM-12471 30mg; ORM-12741; Ofev; Omeprazole; Omeprazole 20mg; Onabotulinumtoxin A; Ophthalmic Emulsion; Opsumit 10 Mg Tablet; Oral Ifetroban; Oral bovine type I collagen; Oral treprostinil; Orencia; Other vasodilator; Other: Biopsy; Other: Bronchoalveolar samples; Other: Laboratory Biomarker Analysis; Other: Physalis angulata ethanol extract; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Rosemary essential oil; Other: Vasculopathy assessment; Other: flow cytometry; Other: laboratory biomarker analysis; Other: sodium chloride; Ozone; P144; P144 Cytokine Inhibitor; P144 Cytokines Inhibitors; P144 DIGNA CREAM; P144 cream; P144. Cytokines Inhibitors; PFD; PIRFENIDONE; PLETAL; PR1; PRUCALOPRIDE SUCCINATE; Paquinimod; Part B Open-Label Extension; Patients will be randomized to receive EHP-101; Penicillamine; Peripheral Blood Stem Cells; Phosphate; Phosphodiesterase Inhibitors; Physiological saline; Pirfenidone; Pirfenidone (PFD); Placebo; Platelet Gel; Plerixafor; Pletal; Polydeoxyribonucleotides; Pomalidomida; Pomalidomide; Pomalidomide (CC-4047); Prednisolon; Prednisolona; Prednisolone; Prednisolone 5 mg; Prednisolone 5mg Gastro-resistant Tablets; Prednisolone and taper; Prednisoloni; Prednisolonum; Prednisone; Prednizolon; Prednizolonas; Privigen; Procedure: 2 ml of whole blood sample will be collected on EDTA tube; Procedure: Adipose tissue harvest; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Leukapheresis; Procedure: Leukopheresis; Procedure: Order of two elements of surgical procedure; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: Self bone marrow transplant; Procedure: Total Body Irradiation; Procedure: Total-Body Irradiation; Procedure: biopsy; Procedure: bone marrow transplantation; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Procedure: quality-of-life assessment; Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation; Procedure: stem cell transplantation; Propylene glycol; Prostanoids; Prucalopride; QAX576; RATG; RESOLOR*28CPR RIV 2MG; RIOCIGUAT; RO487-7533/F10-04; Rabbit; Rabeprazole; Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Intensity-Modulated Radiation Therapy; Radiation: Total Body Irradiation; Radiation: total-body irradiation; Rapamycin; RbATG; Recombinant humanized anti-human monoclonal antibody directed against the IL-6R; Relaxin; Resolor; Resunab, ajulemic acid, anabasum; Rilonacept; Ringer lactate; Riocigu; Riociguat; Riociguat (Adempas, BAY63-2521); Riociguat coated tablet 0.5 mg; Riociguat coated tablet 1.0 mg; Riociguat coated tablet 1.5 mg; Riociguat coated tablet 2.0 mg; Riociguat coated tablet 2.5 m; Riociguat coated tablet 2.5 mg; Rituximab; Ro 47-0203; Ro 487-7533/F10-04; Ro47-0203 / ACT-050088; RoActemra; RoActemra 162 mg; Rosemary; Rosuvastatin; SAR100842; SAR156597; SAR156597 (ACT14604); SAR231893; SELEXIPAG; SINVACOR*28CPR RIV 20MG; SODIUM NITROPRUSSIDE; SODIUM THIOSULFATE PENTAHYDRATE; STI571; STS; Saccharomyces; Saccharomyces Boulardii Oral Tablet; Selexipag; Sildenafil; Sildenafil 20mg; Sildenafil 20mg and Bosentan 62.5mg; Sildenafil citrate; Sildenafil therapy; Simvastatin; Sinvacor; Sirolimus; Sodium Thiosulfate 10%; Sodium chloride; Sodium fluoride; Sodium fluoride 18F; Sodium thiosulfate; Sodium thiosulfate 10%; Solu-Medrol; Solu-Medrone; Solu-medrol; Solu-medrone; Soluble Ve cadherin; Standard of care; Sterile saline solution; Steroids; Stromal Vascular fraction; Study of the gene expression profile; TEPEZZA; TERGURIDE HYDROGENMALEATE; TOCILIZUMAB; TRACLEER*125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TREPROSTINIL SODIUM; Tacrolimus; Tadalafil; Tadalafil and ambrisentan upfront combination therapy; Tepezza; Terguride; Thalidomide; Thiotepa; Thymoglobulin; Thymoglobuline; Tocilizumab; Tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS); Tocilizumab [RoActemra/Actemra]; Tofacitinib; Topical AmphiMatrix; Topical AmphiMatrix with nitroglycerin (MQX-503); Topical calcipotriene 0.005% ointment; Topical organogel with nitroglycerin; Tracleer; Transdihydrolisuride; Treprostinil; Treprostinil Sodium; Treprostinil diethanolamine; Trimebutine; Trometamol; UCMSC; UT-15 SR; UT-15C SR; UT-15C-SR; Urine sample; VIB7734; VIP; Vaseline; Veledimex; Vessel; Vivomixx probiotics; Volibris; Water; Yellow Fever Vaccine; Yellow Fever vaccine (17D); ZD4054; Zibotentan; Ziritaxestat

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04647890 (ClinicalTrials.gov)	February 2021	16/11/2020	Effects of FT011 in Systemic Sclerosis	A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis	Scleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, Systemic	Drug: FT011;Drug: Placebo	Certa Therapeutics	NULL	Not yet recruiting	18 Years	75 Years	All	30	Phase 2	NULL
2	NCT04515706 (ClinicalTrials.gov)	January 1, 2021	13/8/2020	Iguratimod in Systemic Sclerosis	Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis	Systemic Sclerosis, Diffuse	Drug: Iguratimod;Drug: Placebo	RenJi Hospital	NULL	Not yet recruiting	19 Years	74 Years	All	20	N/A	NULL
3	NCT04440592 (ClinicalTrials.gov)	December 31, 2020	17/6/2020	Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis	Drug: MT-7117;Drug: Placebo	Mitsubishi Tanabe Pharma Development America, Inc.	NULL	Recruiting	18 Years	75 Years	All	72	Phase 2	United States
4	EUCTR2020-000134-17-GB (EUCTR)	23/12/2020	05/08/2020	A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117	Mitsubishi Tanabe Pharma Development America (MTDA), Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72	Phase 2	United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom
5	EUCTR2020-002081-13-NL (EUCTR)	02/11/2020	17/08/2020	A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).	A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc)	Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248	Gesynta Pharma AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	Netherlands;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT04478994 (ClinicalTrials.gov)	November 2020	16/7/2020	A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis	Biological: TEPEZZA;Other: Placebo	Horizon Therapeutics USA, Inc.	NULL	Recruiting	18 Years	80 Years	All	25	Phase 1	United States
7	NCT04356287 (ClinicalTrials.gov)	October 2020	15/4/2020	Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis	Phase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic Sclerosis	Sclerosis, Systemic;Mesenchymal Stem Cells	Biological: UCMSC;Other: Placebo	Marie Hudson, MD	Assistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health Centre	Not yet recruiting	18 Years	N/A	All	18	Phase 1;Phase 2	NULL
8	NCT04300426 (ClinicalTrials.gov)	September 24, 2020	25/2/2020	Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)	Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week Study	Systemic Sclerosis	Drug: ACHIM as solute (10^9 intestinal microbes/ml)	Oslo University Hospital	South-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North Norway	Recruiting	18 Years	85 Years	All	70	Phase 2	Norway
9	NCT04356755 (ClinicalTrials.gov)	September 22, 2020	11/3/2020	Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.	Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma	Systemic Sclerosis	Procedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: Placebo	University Hospital, Toulouse	NULL	Recruiting	18 Years	N/A	All	32	Phase 2	France
10	EUCTR2020-002081-13-GB (EUCTR)	08/09/2020	21/07/2020	A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).	A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc)	Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248	Gesynta Pharma AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2019-000906-31-DE (EUCTR)	01/07/2020	31/10/2019	Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)	A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis	efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN	CSL Behring GmbH	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 2	United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
12	NCT04166552 (ClinicalTrials.gov)	June 11, 2020	6/11/2019	Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis	A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis	Drug: Patients will be randomized to receive EHP-101 or Placebo	Emerald Health Pharmaceuticals Inc.	Iqvia Pty Ltd	Recruiting	18 Years	70 Years	All	36	Phase 2	United States;Australia;New Zealand
13	EUCTR2019-000906-31-GB (EUCTR)	22/05/2020	29/10/2019	Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)	A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis	efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN	CSL Behring GmbH	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 2	United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
14	NCT04200755 (ClinicalTrials.gov)	May 19, 2020	10/12/2019	Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma	A Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized Scleroderma	Localized Scleroderma	Drug: Dupilumab 300Mg Solution for Injection;Other: Placebo	University of Cologne	NULL	Recruiting	18 Years	N/A	All	45	Phase 2	Germany
15	EUCTR2019-000906-31-PL (EUCTR)	31/01/2020	06/12/2019	Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)	A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis	efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN	CSL Behring GmbH	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 2	United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT04388176 (ClinicalTrials.gov)	January 3, 2020	11/5/2020	Cold Challenge With C21 in RP	A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)	Raynaud Phenomenon;Systemic Sclerosis	Drug: C21;Drug: Placebo	Vicore Pharma AB	SGS Life Sciences, a division of SGS Belgium NV	Recruiting	19 Years	75 Years	All	16	Phase 2	United Kingdom
17	NCT04138485 (ClinicalTrials.gov)	December 20, 2019	14/10/2019	Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)	A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis	Biological: IgPro10;Biological: Placebo	CSL Behring	NULL	Withdrawn	18 Years	N/A	All	0	Phase 2	United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom
18	EUCTR2019-000906-31-ES (EUCTR)	16/12/2019	20/12/2019	Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)	A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis	efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		CSL Behring GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	188	Phase 2	United States;Spain;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
19	EUCTR2019-003203-35-GB (EUCTR)	13/12/2019	05/09/2019	NA	A Phase 2, single-center, randomised, double-blind, placebo-controlled, cross-over, cold challenge study investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc)	Systemic sclerosis (SSc)Raynaud’s phenomenon (RP) MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: NA Product Code: C21 INN or Proposed INN: NA Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt	Vicore Pharma AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	16	Phase 2	United Kingdom
20	EUCTR2019-000906-31-FR (EUCTR)	03/12/2019	08/11/2019	Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)	A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis	efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN	CSL Behring GmbH	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 2	United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2019-002036-90-DE (EUCTR)	02/12/2019	02/10/2019	Study to test effectiveness and safety of the drug Dupilumab in patients with localized scleroderma	A randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma - DupiMorph	Localized scleroderma MedDRA version: 21.1;Level: LLT;Classification code 10009206;Term: Circumscribed scleroderma;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10027979;Term: Morphea;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Dupilumab Product Code: Dupilumab INN or Proposed INN: Dupilumab Other descriptive name: SAR231893	University of Cologne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	Germany
22	NCT04040322 (ClinicalTrials.gov)	October 14, 2019	30/7/2019	Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)	Raynaud's Phenomenon Secondary to Systemic Sclerosis	Drug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous use	Eicos Sciences, Inc.	NULL	Recruiting	18 Years	N/A	All	180	Phase 3	United States
23	NCT03844061 (ClinicalTrials.gov)	July 29, 2019	31/1/2019	Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis	Drug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMF	Hospital for Special Surgery, New York	GlaxoSmithKline	Recruiting	18 Years	80 Years	All	30	Phase 2	United States
24	NCT04045743 (ClinicalTrials.gov)	July 19, 2019	27/7/2019	The Benefit of Bermekimab in Patients With Systemic Sclerosis	Clinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)	Scleroderma, Systemic	Drug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab)	Hellenic Institute for the Study of Sepsis	NULL	Recruiting	18 Years	N/A	All	20	Phase 2	Greece
25	EUCTR2015-004613-24-BE (EUCTR)	17/07/2019	18/04/2019	Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.	Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early	(very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Solu-Medrol Product Name: methylprednisolon INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Radboudumc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Belgium;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT03919799 (ClinicalTrials.gov)	July 9, 2019	21/11/2018	KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis	A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic Sclerosis	System; Sclerosis;Diffuse Cutaneous Systemic Sclerosis	Drug: Belumosudil (KD025);Drug: Placebo	Kadmon Corporation, LLC	NULL	Recruiting	18 Years	100 Years	All	60	Phase 2	United States
27	NCT04036227 (ClinicalTrials.gov)	July 3, 2019	23/7/2019	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248	A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)	Healthy	Drug: GS-248;Drug: Placebo	Gesynta Pharma AB	CTC Clinical Trial Consultants	Completed	18 Years	75 Years	All	72	Phase 1	Sweden
28	JPRN-JapicCTI-194761	23/5/2019	17/05/2019	A Phase 3 study of KHK4827 in patients with systemic sclerosis	A Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickening	Systemic sclerosis	Intervention name : KHK4827 INN of the intervention : Brodalumab Dosage And administration of the intervention : 210 mg Q2W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : 210 mg Q2W, SC	Kyowa Kirin Co., Ltd.	NULL	complete	18	70	BOTH	100	Phase 3	Japan
29	NCT03957681 (ClinicalTrials.gov)	May 23, 2019	16/5/2019	A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis	A Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin Thickening	Moderate to Severe Systemic Sclerosis	Drug: KHK4827;Drug: Placebo	Kyowa Kirin Co., Ltd.	NULL	Active, not recruiting	18 Years	70 Years	All	100	Phase 3	Japan
30	EUCTR2018-001817-33-BE (EUCTR)	05/04/2019	23/01/2019	A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis	A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis	Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	United States;Spain;Belgium;Germany;United Kingdom;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2018-001817-33-DE (EUCTR)	29/03/2019	23/01/2019	A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis	A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis	Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	United States;Belgium;Spain;Germany;Italy;United Kingdom
32	NCT03867097 (ClinicalTrials.gov)	March 4, 2019	6/3/2019	Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis	Raynaud Phenomenon Secondary to Systemic Sclerosis	Drug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous use	Eicos Sciences, Inc.	NULL	Completed	18 Years	N/A	All	41	Phase 2	United States
33	EUCTR2018-001817-33-GB (EUCTR)	14/01/2019	20/11/2018	A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis	A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis	Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690	Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	United States;Spain;Belgium;Germany;Italy;United Kingdom
34	NCT03798366 (ClinicalTrials.gov)	January 14, 2019	3/1/2019	A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis	A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis	Scleroderma	Drug: GLPG1690;Drug: Placebo	Galapagos NV	NULL	Completed	18 Years	N/A	All	33	Phase 2	United States;Belgium;Germany;Italy;Spain;United Kingdom
35	NCT03817424 (ClinicalTrials.gov)	December 13, 2018	22/1/2019	A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis	A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis	Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis	Drug: VIB7734;Drug: Placebo	Viela Bio	NULL	Completed	18 Years	75 Years	All	31	Phase 1	United States;Poland;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	NCT03211793 (ClinicalTrials.gov)	November 2018	27/4/2017	Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis	Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial	Systemic Sclerosis;Digital Ulcer	Drug: Mesenchymal stromal cells;Other: Placebo	UMC Utrecht	ZonMw: The Netherlands Organisation for Health Research and Development	Unknown status	18 Years	N/A	All	20	Phase 1;Phase 2	Netherlands
37	NCT03717961 (ClinicalTrials.gov)	October 15, 2018	15/10/2018	Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis	Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis	Raynaud Phenomenon Secondary to Systemic Sclerosis	Drug: BOTOX ® solution;Drug: Placebo group	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	N/A	All	91	Phase 3	France
38	EUCTR2017-000372-29-PL (EUCTR)	28/09/2018	02/07/2018	A study of safety and efficacy of lenabasum in Systemic Sclerosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis	Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus Pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	354	Phase 3	United States;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
39	EUCTR2016-003417-95-NL (EUCTR)	18/09/2018	09/07/2018	Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.	A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.	Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: GSK2330811 Solution for Injection, 100mg/ml Product Code: GSK2330811 INN or Proposed INN: GSK2330811 Other descriptive name: GSK2330811	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Canada;Netherlands;United Kingdom
40	NCT03558854 (ClinicalTrials.gov)	August 28, 2018	3/5/2018	Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients	Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis	Systemic Sclerosis	Drug: Acetylsalicylic acid;Drug: Placebo oral capsule	Federal University of São Paulo	NULL	Recruiting	18 Years	65 Years	All	70	Phase 4	Brazil
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2017-000372-29-NL (EUCTR)	21/06/2018	24/01/2018	A study of safety and efficacy of lenabasum in Systemic Sclerosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis	Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum	Corbus pharmaceuticals Inc.	NULL	Not Recruiting			Female: yes Male: yes	354	Phase 3	United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of
42	NCT03856853 (ClinicalTrials.gov)	June 15, 2018	26/2/2019	Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease	A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)	Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)	Drug: Pirfenidone;Other: placebo	Beijing Continent Pharmaceutical Co, Ltd.	Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group)	Recruiting	18 Years	75 Years	All	144	Phase 3	China
43	EUCTR2017-000372-29-ES (EUCTR)	25/04/2018	02/02/2018	A study of safety and efficacy of lenabasum in Systemic Sclerosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis	Systemic Sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Lenabasum 5 mg Powder in Capsule Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum 20 mg Powder in Capsule Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum	Corbus pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	354	Phase 3	United States;Spain;Israel;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
44	EUCTR2017-000372-29-GB (EUCTR)	20/03/2018	07/12/2017	A study of safety and efficacy of lenabasum in Systemic Sclerosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis	Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		Corbus pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	354	Phase 3	United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
45	EUCTR2017-000372-29-DE (EUCTR)	07/03/2018	13/12/2017	A study of safety and efficacy of lenabasum in Systemic Sclerosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis	Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		Corbus pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	354	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	NCT03708718 (ClinicalTrials.gov)	December 21, 2017	8/10/2018	Prednisolone in Early Diffuse Systemic Sclerosis	A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)	Systemic Sclerosis	Drug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'	Prof. Ariane herrick	Versus Arthritis	Recruiting	18 Years	N/A	All	72	Phase 2	United Kingdom
47	NCT03398837 (ClinicalTrials.gov)	December 18, 2017	5/1/2018	Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis	Drug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsule	Corbus Pharmaceuticals Inc.	NULL	Active, not recruiting	18 Years	N/A	All	365	Phase 3	United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
48	NCT04274257 (ClinicalTrials.gov)	December 4, 2017	13/2/2020	A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis	Double-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic Sclerosis	Scleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen Diseases	Drug: Double-Blind Placebo;Drug: Double-Blind Rituximab	Tokyo University	Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.	Completed	20 Years	80 Years	All	56	Phase 2;Phase 3	Japan
49	NCT03221257 (ClinicalTrials.gov)	November 28, 2017	12/7/2017	Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate	Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease	Scleroderma, Systemic;Interstitial Lung Disease	Drug: Pirfenidone (PFD);Drug: Placebo (Plac);Drug: Mycophenolate Mofetil (MMF)	Michael Roth	University of Michigan;Genentech, Inc.;University of California, Los Angeles	Active, not recruiting	18 Years	N/A	All	150	Phase 2	United States
50	NCT03274076 (ClinicalTrials.gov)	September 25, 2017	28/8/2017	Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)	Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability Study	Systemic Sclerosis;Scleroderma	Drug: Tofacitinib;Drug: Placebo Oral Tablet	University of Michigan	Pfizer	Completed	18 Years	70 Years	All	15	Phase 1;Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	NCT03222492 (ClinicalTrials.gov)	September 20, 2017	17/7/2017	Brentuximab Vedotin for Systemic Sclerosis	Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)	Diffuse Cutaneous Systemic Sclerosis;Scleroderma;dcSSc	Biological: Brentuximab Vedotin;Biological: Placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN);Seagen Inc.	Recruiting	18 Years	70 Years	All	24	Phase 1;Phase 2	United States;Canada
52	EUCTR2015-001617-27-BG (EUCTR)	02/08/2017	17/05/2017	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Inventiva SA	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 2	Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
53	EUCTR2015-000392-28-CZ (EUCTR)	27/06/2017	27/04/2017	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	520	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
54	NCT03120533 (ClinicalTrials.gov)	June 20, 2017	23/3/2017	Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study	Therapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study	Scleroderma, Systemic	Drug: Iontophoresis of treprostinil;Drug: Iontophoresis of placebo	University Hospital, Grenoble	Linksium;University Grenoble Alps	Completed	18 Years	N/A	All	18	Phase 1;Phase 2	France
55	EUCTR2015-000392-28-HU (EUCTR)	08/06/2017	26/04/2017	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	NCT03041025 (ClinicalTrials.gov)	June 5, 2017	31/1/2017	Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis	A Multi-center, Randomized, Double-blind (Sponsor Open), Placebo-controlled, Repeat-dose, Proof of Mechanism Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic Sclerosis	Scleroderma, Systemic	Drug: GSK2330811;Drug: Placebo	GlaxoSmithKline	NULL	Completed	18 Years	N/A	All	35	Phase 2	United States;Canada;Netherlands;United Kingdom
57	EUCTR2015-000392-28-NO (EUCTR)	02/06/2017	15/02/2017	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim Norway KS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
58	EUCTR2015-001617-27-SI (EUCTR)	26/05/2017	15/05/2017	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Inventiva SA	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 2	Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
59	EUCTR2015-000392-28-AT (EUCTR)	12/05/2017	31/03/2017	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim RCV GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia
60	EUCTR2015-000392-28-SE (EUCTR)	08/05/2017	24/02/2017	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim AB	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	NCT03068234 (ClinicalTrials.gov)	May 2017	16/2/2017	Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis	A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis	Systemic Sclerosis	Drug: Pirfenidone;Drug: Placebo oral capsule;Drug: Steroids	RenJi Hospital	NULL	Not yet recruiting	18 Years	70 Years	All	72	Phase 2;Phase 3	China
62	EUCTR2015-000392-28-FI (EUCTR)	21/02/2017	10/02/2017	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Boehringer Ingelheim Finland Ky	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
63	EUCTR2015-002586-39-BE (EUCTR)	19/01/2017	14/07/2016	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE	medac GmbH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	Switzerland;Italy;United Kingdom;Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany
64	EUCTR2016-003417-95-GB (EUCTR)	13/01/2017	24/10/2016	Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.	A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.	Systemic sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: GSK2330811 Solution for Injection, 100mg/ml Product Code: GSK2330811 INN or Proposed INN: GSK2330811 Other descriptive name: GSK2330811	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Netherlands;United Kingdom
65	NCT03059979 (ClinicalTrials.gov)	January 2017	25/1/2017	The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )	Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.	Systemic Sclerosis;Raynaud Phenomena	Drug: Methylprednisolone;Other: sodium chloride	Radboud University	NULL	Recruiting	18 Years	N/A	All	30	Early Phase 1	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	NCT02682511 (ClinicalTrials.gov)	January 2017	8/2/2016	Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension	A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)	Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune Diseases	Drug: Oral Ifetroban;Drug: Oral Placebo	Cumberland Pharmaceuticals	NULL	Recruiting	18 Years	80 Years	All	34	Phase 2	United States;India
67	EUCTR2016-001028-80-IT (EUCTR)	19/12/2016	05/11/2020	Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis	Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study - NA	Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NA Product Code: SAR156597 INN or Proposed INN: non applicabile	SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT	NULL	Not Recruiting			Female: yes Male: yes	94	Phase 2	United States;Estonia;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
68	JPRN-UMIN000024818	2016/12/12	14/11/2016	The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis	The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis - The efficacy and safety of BTX-B on digital ulcers in patients with SSc	digital ulcers in systemic sclerosis patients	placebo subcutaneously injection into hands with digital ulcers botulinum toxin type B subcutaneously injection into hands with digital ulcers	Gunma University Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	20	Not selected	Japan
69	NCT02981082 (ClinicalTrials.gov)	December 2016	30/11/2016	Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension	A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.	Systemic Sclerosis;Pulmonary; Hypertension	Drug: Dimethyl Fumarate (DMF);Drug: Placebo Oral Tablet	Robert Lafyatis	Biogen	Terminated	18 Years	80 Years	All	6	Phase 1	United States
70	NCT03053739 (ClinicalTrials.gov)	December 2016	29/12/2016	To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis	Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis	Associated Pulmonary Arterial Hypertension	Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo	Postgraduate Institute of Medical Education and Research	NULL	Recruiting	18 Years	N/A	All	50	Phase 4	India
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	NCT02921971 (ClinicalTrials.gov)	November 23, 2016	30/9/2016	Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis	Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study	Systemic Sclerosis	Drug: SAR156597 (ACT14604);Drug: Placebo	Sanofi	NULL	Completed	18 Years	N/A	All	97	Phase 2	United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
72	EUCTR2016-001028-80-DE (EUCTR)	08/11/2016	18/07/2016	Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis	Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study	Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: SAR156597	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	94	Phase 2	United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
73	EUCTR2015-002586-39-GB (EUCTR)	18/10/2016	19/07/2016	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE	medac GmbH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;Switzerland;United Kingdom
74	EUCTR2015-000424-28-IE (EUCTR)	17/10/2016	19/08/2016	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
75	EUCTR2016-001028-80-EE (EUCTR)	04/10/2016	20/09/2016	Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis	Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study	Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	94	Phase 2	United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2015-002586-39-PT (EUCTR)	03/10/2016	06/07/2016	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE	medac GmbH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	France;United States;Portugal;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
77	NCT02896205 (ClinicalTrials.gov)	October 2016	27/8/2016	Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease	A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease	Systemic Sclerosis;Scleroderma;Interstitial Lung Disease	Drug: Mycophenolate mofetil;Drug: Placebo	Postgraduate Institute of Medical Education and Research	NULL	Completed	18 Years	N/A	All	41	Phase 3	India
78	EUCTR2016-001028-80-AT (EUCTR)	30/09/2016	27/07/2016	Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis	Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study	Systemic sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	94	Phase 2	United States;Estonia;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
79	EUCTR2016-001028-80-BE (EUCTR)	26/09/2016	02/08/2016	Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis	Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study	Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	94	Phase 2	United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
80	EUCTR2015-002586-39-HU (EUCTR)	20/09/2016	12/07/2016	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		medac GmbH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2015-002586-39-FR (EUCTR)	13/09/2016	21/07/2016	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE	medac GmbH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	Portugal;United States;France;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
82	NCT02915835 (ClinicalTrials.gov)	September 2016	15/9/2016	Riociguat in Scleroderma Associated Digital Ulcers	A Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital Ulcers	Scleroderma;Digital Ulcers	Drug: Riociguat;Drug: Placebo	Dinesh Khanna, MD, MS	Bayer	Completed	18 Years	N/A	All	17	Phase 2	United States
83	EUCTR2015-005023-11-IT (EUCTR)	29/08/2016	23/02/2018	Abituzumab in SSc-ILD	A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS	Systemic sclerosis-associated interstitial lung disease (SSc-ILD) MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Abituzumab Product Code: EMD 525797 INN or Proposed INN: abituzumab	MERCK KGAA	NULL	Not Recruiting			Female: yes Male: yes	175	Phase 2	France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;United Kingdom;Italy
84	EUCTR2015-002586-39-DE (EUCTR)	03/08/2016	29/06/2016	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE	medac GmbH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
85	EUCTR2015-002586-39-IT (EUCTR)	27/07/2016	06/02/2018	Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis	Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Terguride Product Code: / INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride Product Code: / INN or Proposed INN: TERGURIDE HYDROGENMALEATE Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL Product Name: Metoclopramide Product Code: / INN or Proposed INN: METOCLOPRAMIDE Other descriptive name: METOCLOPRAMIDE	MEDAC GMBH	NULL	Not Recruiting			Female: yes Male: yes	148	Phase 3	Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2015-005023-11-PL (EUCTR)	12/07/2016	20/06/2016	Abituzumab in SSc-ILD	A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS	Systemic sclerosis-associated interstitial lung disease (SSc-ILD) MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Abituzumab INN or Proposed INN: abituzumab Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	175	Phase 2	France;United States;Canada;Argentina;Spain;Poland;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
87	EUCTR2015-005023-11-GB (EUCTR)	08/07/2016	25/05/2016	Abituzumab in SSc-ILD	A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS	Systemic sclerosis-associated interstitial lung disease (SSc-ILD) MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Abituzumab INN or Proposed INN: abituzumab Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	175	Phase 2	France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
88	EUCTR2015-005023-11-ES (EUCTR)	04/07/2016	27/06/2016	Abituzumab in SSc-ILD	A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS	Systemic sclerosis-associated interstitial lung disease (SSc-ILD) MedDRA version: 19.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Abituzumab INN or Proposed INN: abituzumab Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	175	Phase 2	France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
89	EUCTR2015-000392-28-IE (EUCTR)	27/06/2016	13/04/2016	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
90	EUCTR2015-001617-27-NL (EUCTR)	07/06/2016	06/04/2016	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys. MedDRA version: 18.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 18.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: IVA337 Product Code: IVA337 INN or Proposed INN: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID	Inventiva SAS	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 2	Slovenia;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	NCT02745145 (ClinicalTrials.gov)	May 31, 2016	15/4/2016	Abituzumab in SSc-ILD	A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)	Systemic Sclerosis-associated Interstitial Lung Disease	Drug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: Placebo	EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany	Terminated	18 Years	75 Years	All	24	Phase 2	United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
92	EUCTR2015-004613-24-NL (EUCTR)	30/05/2016	13/04/2016	Hit hard and early	Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized double-blind placebo-controlled trial. - Hit hard and early	(very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: methylprednisolon INN or Proposed INN: methylprednisolon Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE	Radboudumc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Netherlands
93	EUCTR2015-000392-28-PL (EUCTR)	09/03/2016	21/01/2016	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer-Ingelheim RCV GmbH&Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden
94	NCT02370693 (ClinicalTrials.gov)	March 2016	11/2/2015	Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis	Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558	Interstitial Lung Disease;ILD;Systemic Sclerosis;Scleroderma	Drug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetil	Northwestern University	National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	18 Years	N/A	All	30	Phase 2	United States
95	NCT02588625 (ClinicalTrials.gov)	February 2016	26/10/2015	A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)	A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)	Scleroderma	Drug: BMS-986020;Other: Placebo	Bristol-Myers Squibb	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 2	United States;Canada;Poland;United Kingdom;France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2015-000424-28-GR (EUCTR)	26/01/2016	30/12/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
97	JPRN-JapicCTI-152963	08/1/2016	09/07/2015	Phase III Study of Tocilizumab in Patients with Systemic Sclerosis	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis	Intervention name : Tocilizumab INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg/W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo/W, SC	Chugai Pharmaceutical Co., Ltd.	F.Hoffmann-La Roche Ltd	complete	18		BOTH	210	Phase 3	Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.
98	EUCTR2015-000392-28-PT (EUCTR)	08/01/2016	14/09/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Unilfarma - União Internacional de Lab. Farmacêuticos, Lda	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
99	NCT02530996 (ClinicalTrials.gov)	January 1, 2016	29/7/2015	Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment	Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment	Rheumatologic Disease	Drug: BH4;Other: Vasculopathy assessment;Drug: Placebo	VA Office of Research and Development	NULL	Completed	18 Years	95 Years	All	32		United States
100	NCT03141125 (ClinicalTrials.gov)	January 2016	20/6/2016	The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy	The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and Fibrosis	Scleroderma	Other: Physalis angulata ethanol extract;Other: Placebo	Indonesia University	Netherlands: Ministry of Health, Welfare and Sports	Completed	18 Years	60 Years	All	62	N/A	Indonesia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2015-000424-28-NL (EUCTR)	22/12/2015	21/09/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
102	EUCTR2015-000424-28-HR (EUCTR)	18/12/2015	01/02/2016	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 3	Portugal;United States;Greece;Spain;Lithuania;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Japan
103	EUCTR2015-000392-28-FR (EUCTR)	11/12/2015	14/12/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim France	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
104	EUCTR2015-000392-28-BE (EUCTR)	08/12/2015	25/09/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	SCS Boehringer Ingelheim Comm. V	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	520	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
105	NCT02453256 (ClinicalTrials.gov)	November 20, 2015	21/5/2015	A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis	Systemic Sclerosis	Drug: Placebo;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	212	Phase 3	United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2015-000392-28-ES (EUCTR)	19/11/2015	05/10/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
107	EUCTR2015-000392-28-GR (EUCTR)	18/11/2015	22/10/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim Ellas SA	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
108	NCT02597933 (ClinicalTrials.gov)	November 12, 2015	8/10/2015	A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis	A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)	Scleroderma, Systemic	Drug: Nintedanib;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	18 Years	N/A	All	580	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom
109	EUCTR2015-000392-28-DE (EUCTR)	11/11/2015	25/08/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
110	EUCTR2015-000392-28-GB (EUCTR)	10/11/2015	01/09/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2015-000392-28-NL (EUCTR)	02/11/2015	24/08/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB	Boehringer Ingelheim bv	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
112	NCT03531216 (ClinicalTrials.gov)	November 2, 2015	9/5/2018	Topical Rosemary Oil Application in Systemic Sclerosis	Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial	Systemic Sclerosis	Other: Rosemary essential oil;Other: Placebo	ARCIM Institute Academic Research in Complementary and Integrative Medicine	University Hospital Tuebingen	Completed	18 Years	N/A	All	12	N/A	Germany
113	EUCTR2015-000424-28-DE (EUCTR)	02/11/2015	27/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
114	NCT02503644 (ClinicalTrials.gov)	October 29, 2015	30/6/2015	Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis	A Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic Sclerosis	Scleroderma, Diffuse;Diffuse Cutaneous Systemic Sclerosis	Drug: IVA337;Drug: Placebo	Inventiva Pharma	NULL	Completed	18 Years	75 Years	All	145	Phase 2	Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom
115	EUCTR2015-001617-27-DE (EUCTR)	23/10/2015	28/08/2015	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Inventiva SA	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 2	Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	EUCTR2015-000424-28-LT (EUCTR)	14/10/2015	29/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
117	EUCTR2015-000392-28-DK (EUCTR)	22/09/2015	22/09/2015	A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis	A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD	Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Boehringer-Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
118	EUCTR2015-000424-28-HU (EUCTR)	22/09/2015	11/08/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED	Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
119	EUCTR2015-001617-27-IT (EUCTR)	18/09/2015	17/06/2015	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys. MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: IVA337 Product Code: IVA337 INN or Proposed INN: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID	Inventiva SAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	105	Phase 2	Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy
120	EUCTR2014-005323-27-GB (EUCTR)	16/09/2015	29/09/2015	A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosis	A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial - The Abatacept Systemic SclErosis Trial (ASSET)	Diffuse Cutaneous Systemic Sclerosis MedDRA version: 18.0;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		University of Michigan	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2	United States;Canada;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2015-001617-27-GB (EUCTR)	16/09/2015	17/07/2015	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc) - IVA337 SSc POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. MedDRA version: 19.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Inventiva SA	NULL	Not Recruiting			Female: yes Male: yes	170	Phase 2	Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom
122	EUCTR2015-000424-28-DK (EUCTR)	10/09/2015	17/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
123	EUCTR2015-001617-27-ES (EUCTR)	08/09/2015	10/07/2015	A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.	A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. - IVA337 SSC POC	Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: IVA337 Product Code: IVA337 INN or Proposed INN: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID	Inventiva SAS	NULL	Not Recruiting			Female: yes Male: yes	105	Phase 2	Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland
124	EUCTR2015-000424-28-BE (EUCTR)	07/09/2015	28/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
125	NCT02551042 (ClinicalTrials.gov)	September 2015	17/12/2014	CSL Behring Sclero XIII	A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis	Systemic Sclerosis	Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chloride	University College, London	CSL Behring	Recruiting	18 Years	N/A	Both	26	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2015-000424-28-ES (EUCTR)	07/08/2015	04/08/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
127	NCT02465437 (ClinicalTrials.gov)	August 2015	4/6/2015	Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis	Diffuse Cutaneous Systemic Sclerosis	Drug: JBT-101;Drug: Placebo;Drug: Part B Open-Label Extension	Corbus Pharmaceuticals Inc.	NULL	Active, not recruiting	18 Years	70 Years	All	42	Phase 2	United States
128	EUCTR2015-000424-28-PT (EUCTR)	31/07/2015	30/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
129	NCT02349009 (ClinicalTrials.gov)	June 2015	18/1/2015	Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial	A Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial	Systemic Scleroderma	Drug: C-82 Topical Gel, 1%;Drug: C-82 Topical Gel, Placebo	Prism Pharma Co., Ltd.	NULL	Completed	18 Years	N/A	All	17	Phase 1;Phase 2	United States
130	NCT02386436 (ClinicalTrials.gov)	April 21, 2015	6/3/2015	A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects	A Phase I, Randomised, Double-blind (Sponsor Open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy Subjects	Scleroderma, Systemic	Drug: GSK2330811;Drug: Placebo	GlaxoSmithKline	NULL	Completed	18 Years	65 Years	All	41	Phase 1	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2014-001353-16-GB (EUCTR)	17/04/2015	03/10/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 m	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
132	EUCTR2014-001101-40-GB (EUCTR)	24/02/2015	14/01/2015	Investigation of safety and therapeutic effect of Fibrogammin® in Scleroderma	Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII	Systemic Sclerosis MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		University College London (UCL)	NULL	Not Recruiting			Female: yes Male: yes	26	Phase 2	United Kingdom
133	EUCTR2014-001353-16-DE (EUCTR)	19/02/2015	16/10/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
134	NCT02370784 (ClinicalTrials.gov)	February 2015	26/1/2015	Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma	The Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic Sclerosis	Scleroderma	Drug: atorvastatin;Drug: Placebo	Robyn T. Domsic, MD, MPH	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	18 Years	70 Years	All	24	Phase 2	United States
135	EUCTR2014-001353-16-CZ (EUCTR)	22/01/2015	06/11/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	EUCTR2014-001353-16-IT (EUCTR)	19/01/2015	14/05/2015	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
137	NCT02283762 (ClinicalTrials.gov)	January 15, 2015	3/11/2014	Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	Scleroderma, Systemic	Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo	Bayer	NULL	Completed	18 Years	N/A	All	121	Phase 2	United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain
138	NCT02165111 (ClinicalTrials.gov)	January 2015	11/6/2014	Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome	A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's Syndrome	Scleroderma;Raynaud's Syndrome	Drug: Onabotulinumtoxin A;Drug: sterile saline solution	Johns Hopkins University	Allergan	Completed	18 Years	N/A	All	40	Phase 3	United States
139	EUCTR2014-001353-16-NL (EUCTR)	31/12/2014	20/10/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Bayer AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
140	EUCTR2014-001353-16-HU (EUCTR)	30/12/2014	14/11/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2014-001353-16-ES (EUCTR)	22/12/2014	03/11/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT	Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
142	EUCTR2014-001353-16-BE (EUCTR)	09/12/2014	21/10/2014	Effectiveness and safety of riociguat in patients with sclerosis of the skin	A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)	diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Bayer HealthCare AG	NULL	Not Recruiting			Female: yes Male: yes	130	Phase 2	United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
143	NCT02228850 (ClinicalTrials.gov)	November 2014	20/8/2014	Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)	Raynaud's Phenomenon Secondary to Systemic Sclerosis	Drug: Alprostadil;Other: Placebo	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)	NULL	Completed	18 Years	79 Years	Both	35	Phase 2	United States
144	EUCTR2014-000865-34-DE (EUCTR)	31/10/2014	10/09/2014	A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis	A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis	Raynaud's Phenomenon secondary to Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	Germany;United Kingdom
145	NCT02047708 (ClinicalTrials.gov)	October 2014	22/1/2014	Zibotentan Better Renal Scleroderma Outcome Study	A Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to Scleroderma	Scleroderma;Scleroderma Renal Crisis;Chronic Kidney Disease	Drug: Zibotentan	University College, London	Medical Research Council	Completed	18 Years	N/A	All	27	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	NCT02260557 (ClinicalTrials.gov)	October 2014	6/10/2014	Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	Raynaud's Phenomenon Secondary to Systemic Sclerosis	Drug: Selexipag;Drug: Placebo	Actelion	NULL	Completed	18 Years	N/A	Both	74	Phase 2	France;Germany;United Kingdom
147	EUCTR2014-000865-34-GB (EUCTR)	16/09/2014	10/09/2014	A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis	A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis	Raynaud's Phenomenon secondary to Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	70	Phase 2	Germany;United Kingdom
148	NCT02161406 (ClinicalTrials.gov)	September 2014	3/6/2014	A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis	A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.	Diffuse Cutaneous Systemic Sclerosis	Drug: Abatacept;Drug: Placebo	Dinesh Khanna, MD, MS	Bristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID)	Completed	18 Years	N/A	All	88	Phase 2	United States;Canada;United Kingdom
149	NCT02290613 (ClinicalTrials.gov)	July 1, 2014	31/10/2014	Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)	Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA	Systemic Sclerosis;Pulmonary Hypertension	Drug: Ambrisentan;Drug: Placebo	Heidelberg University	GlaxoSmithKline	Completed	18 Years	N/A	All	38	Phase 2	Germany
150	EUCTR2013-003200-39-GB (EUCTR)	01/04/2014	04/04/2014	Investigation of Zibotentan for kidney disease in scleroderma	A phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA)	Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease). MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857 MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		University College London	NULL	Not Recruiting			Female: yes Male: yes	72	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2010-022710-77-CZ (EUCTR)	06/01/2014	02/02/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
152	EUCTR2012-004955-35-IT (EUCTR)	29/07/2013	30/05/2013	A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”	A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”	SYSTEMIC SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Mabthera	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
153	NCT01878526 (ClinicalTrials.gov)	June 2013	7/6/2013	Gastroesophageal Reflux Treatment in Scleroderma	The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis	Gastroesophageal Reflux Disease;Systemic Sclerosis;Scleroderma	Drug: Alginic acid;Drug: placebo (for domperidone);Drug: Domperidone;Drug: placebo (of alginic acid)	Khon Kaen University	NULL	Completed	18 Years	65 Years	All	80	Phase 3	Thailand
154	NCT01804959 (ClinicalTrials.gov)	May 2013	3/3/2013	Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease	A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease	Systemic Sclerosis	Dietary Supplement: Vivomixx probiotics	Singapore General Hospital	NULL	Unknown status	18 Years	N/A	All	40	Phase 2	Singapore
155	NCT01748084 (ClinicalTrials.gov)	April 9, 2013	10/12/2012	Rituximab in Systemic Sclerosis	Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis	Systemic Sclerosis	Drug: Rituximab;Drug: Placebo (NaCl)	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	80 Years	All	22	Phase 2;Phase 3	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	NCT01785056 (ClinicalTrials.gov)	April 2013	28/1/2013	IVIG Treatment in Systemic Sclerosis	A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis	Systemic Sclerosis;Diffuse Scleroderma	Biological: Privigen	Georgetown University	CSL Behring	Unknown status	18 Years	N/A	All	14	N/A	United States
157	EUCTR2012-001369-34-IT (EUCTR)	12/02/2013	21/12/2012	Proof of biological activity of SAR100842 in Systemic Sclerosis	Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: SAR100842 Product Name: NA Product Code: SAR100842	SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT	NULL	Not Recruiting			Female: yes Male: yes	30		United States;Canada;Germany;United Kingdom;Switzerland;Italy
158	NCT01570764 (ClinicalTrials.gov)	January 14, 2013	2/4/2012	Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease	Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease	Systemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung Fibrosis	Drug: Cyclophosphamide;Drug: Placebo	Assistance Publique - Hôpitaux de Paris	Hôpital Claude-Huriez	Completed	18 Years	N/A	All	40	Phase 3	France
159	NCT01651143 (ClinicalTrials.gov)	January 2013	24/7/2012	Proof of Biological Activity of SAR100842 in Systemic Sclerosis	Double-blind, Randomized, Placebo-controlled, 8-week Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis	Drug: SAR100842;Drug: Placebo	Sanofi	NULL	Completed	18 Years	N/A	Both	30	Phase 2	United States;France;Italy;Switzerland;United Kingdom;Germany
160	EUCTR2012-001369-34-DE (EUCTR)	19/11/2012	17/08/2012	Proof of biological activity of SAR100842 in Systemic Sclerosis	Initial title : Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic SclerosisRevised title according to the protocol amendment 4 :Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: SAR100842 Product Code: SAR100842	Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	30		United States;Canada;Germany;United Kingdom;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2012-001369-34-GB (EUCTR)	26/10/2012	15/06/2012	Proof of biological activity of SAR100842 in Systemic Sclerosis	Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	United States;Canada;Germany;Italy;Switzerland;United Kingdom
162	NCT01559129 (ClinicalTrials.gov)	August 9, 2012	19/3/2012	Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease	A Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung Disease	Scleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung Disease	Drug: Pomalidomide (CC-4047);Drug: Placebo	Celgene	NULL	Terminated	18 Years	80 Years	All	23	Phase 2	United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
163	NCT01670565 (ClinicalTrials.gov)	August 2012	15/8/2012	Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.	Systemic Sclerosis	Drug: Belimumab	Hospital for Special Surgery, New York	Human Genome Sciences Inc.	Completed	18 Years	N/A	All	20	Phase 2	United States
164	EUCTR2010-023047-15-PL (EUCTR)	17/07/2012	14/05/2012	A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease	A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease	systemic sclerosis associated with interstitial lung disease MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Pomalidomide Product Code: CC -4047 INN or Proposed INN: Pomalidomide	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
165	EUCTR2010-022969-95-PL (EUCTR)	30/05/2012	12/03/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	EUCTR2010-022710-77-PL (EUCTR)	30/05/2012	12/03/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
167	EUCTR2010-022710-77-IT (EUCTR)	11/04/2012	09/02/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis)	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA	ACTELION PHARMACEUTICALS LTD.	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
168	EUCTR2010-022969-95-GR (EUCTR)	02/04/2012	28/03/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
169	EUCTR2010-023047-15-IT (EUCTR)	20/03/2012	28/12/2011	A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease	A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease	Diffuse cutaneous systemic sclerosis with interstitial lung disease MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Pomalidomide Product Code: CC -4047 INN or Proposed INN: Pomalidomide Other descriptive name: Pomalidomide	CELGENE CORPORATION	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
170	EUCTR2010-023047-15-DE (EUCTR)	15/03/2012	08/12/2011	A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease	A Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease	systemic sclerosis associated with interstitial lung disease MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: Imnovid 1 mg hard capsules INN or Proposed INN: Pomalidomide	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	EUCTR2010-023047-15-GB (EUCTR)	08/03/2012	15/12/2011	A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease	A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease	systemic sclerosis associated with interstitial lung disease MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
172	EUCTR2010-023047-15-ES (EUCTR)	02/03/2012	19/01/2012	A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease	A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease	diffuse cutaneous systemic sclerosis associated with interstitial lung disease MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Pomalidomida Product Code: CC -4047 INN or Proposed INN: Pomalidomida	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	88	Phase 2	France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden
173	NCT01553981 (ClinicalTrials.gov)	March 2012	11/3/2012	A Trial of Tadalafil in Interstitial Lung Disease of Scleroderma	A Double Blind Randomized Control Trial of Tadalafil in Interstitial Lung Disease of Scleroderma	Lung Diseases, Interstitial	Drug: Tadalafil;Drug: Placebo	Sanjay Gandhi Postgraduate Institute of Medical Sciences	NULL	Completed	18 Years	70 Years	Both	40	Phase 3	India
174	NCT01532869 (ClinicalTrials.gov)	March 2012	10/2/2012	A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis	A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis	Sclerosis, Systemic	Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	87	Phase 3	United States;Canada;France;Germany;United Kingdom
175	EUCTR2010-022969-95-NL (EUCTR)	27/02/2012	12/12/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	EUCTR2010-022969-95-PT (EUCTR)	03/02/2012	12/12/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
177	EUCTR2011-001460-22-GB (EUCTR)	19/01/2012	17/10/2011	A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.	A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A	Systemic Sclerosis (SSc) MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]		F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2;Phase 3	France;United States;Canada;Germany;United Kingdom
178	EUCTR2010-022969-95-BE (EUCTR)	16/01/2012	29/11/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285	Phase 3	Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
179	EUCTR2010-022710-77-FI (EUCTR)	10/01/2012	07/12/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
180	EUCTR2010-022969-95-GB (EUCTR)	21/12/2011	27/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295	Phase 3	Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	EUCTR2010-022969-95-IE (EUCTR)	07/12/2011	31/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
182	NCT01474109 (ClinicalTrials.gov)	December 2011	31/10/2011	Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients	Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis	Systemic Sclerosis;Ulcers	Drug: macitentan 3mg;Drug: macitentan 10mg;Drug: placebo	Actelion	NULL	Completed	18 Years	N/A	All	289	Phase 3	United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine
183	NCT01538719 (ClinicalTrials.gov)	December 2011	21/2/2012	IL1-TRAP, Rilonacept, in Systemic Sclerosis	Randomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker Trial	Scleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic Sclerosis	Drug: Rilonacept;Other: Placebo	Boston University	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	24	Phase 1;Phase 2	United States
184	NCT01474122 (ClinicalTrials.gov)	December 2011	31/10/2011	Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients	Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis	Digital Ulcers	Drug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: Placebo	Actelion	NULL	Terminated	18 Years	N/A	All	265	Phase 3	United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom
185	EUCTR2011-001460-22-DE (EUCTR)	28/11/2011	20/10/2011	A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.	A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A	Systemic Sclerosis (SSc) MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS) Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2;Phase 3	France;United States;Canada;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2010-022710-77-BG (EUCTR)	17/11/2011	26/08/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
187	EUCTR2010-022969-95-DE (EUCTR)	09/08/2011	31/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
188	NCT01086540 (ClinicalTrials.gov)	June 24, 2011	11/3/2010	Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)	A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)	Systemic Sclerosis-Associated PAH	Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.	Completed	18 Years	75 Years	All	57	Phase 2	United States
189	EUCTR2010-022710-77-DE (EUCTR)	16/06/2011	31/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
190	EUCTR2010-022969-95-ES (EUCTR)	26/05/2011	18/11/2011	A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).	Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis.	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	NCT01257802 (ClinicalTrials.gov)	May 2011	9/12/2010	GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases	GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases	Lupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial Diffuse	Drug: depot leuprolide acetate 3.75 mg;Drug: Placebo	Joseph Mccune	National Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Terminated	18 Years	40 Years	Female	14	Phase 3	United States
192	NCT01347008 (ClinicalTrials.gov)	April 2011	2/5/2011	Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis	Effect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial	Scleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud Phenomenon	Drug: Sildenafil citrate;Drug: Placebo (Sugar pill)	Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo	Completed	18 Years	N/A	Female	41	Phase 3	Brazil
193	EUCTR2010-022710-77-DK (EUCTR)	22/03/2011	03/02/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
194	EUCTR2010-024005-13-GB (EUCTR)	11/03/2011	30/12/2010	A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.	Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino	Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome) MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: ORM-12741 Product Code: ORM-12741 Other descriptive name: alpha-2C AR antagonist Product Name: ORM-12741 Product Code: ORM-12741 Other descriptive name: Alpha-2C AR antagonist	Orion Corporation Orion Pharma	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
195	NCT01315899 (ClinicalTrials.gov)	March 2011	14/3/2011	Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon	Phase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis	Raynaud's Phenomenon	Drug: ORM-12471 30mg;Drug: ORM-12471;Drug: placebo	Orion Corporation, Orion Pharma	NULL	Terminated	18 Years	75 Years	Both	15	Phase 2	United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	EUCTR2010-022710-77-HU (EUCTR)	28/02/2011	01/02/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
197	NCT01295736 (ClinicalTrials.gov)	November 2010	11/2/2011	Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY	Evaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled Study	Systemic Scleroderma	Drug: Sildenafil;Drug: placebo	University Hospital, Lille	NULL	Completed	18 Years	N/A	Both	84	Phase 3	France
198	NCT00946699 (ClinicalTrials.gov)	March 2010	23/7/2009	A Study of the Safety and Tolerability of MEDI-551 in Scleroderma	A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma	Scleroderma	Biological: MEDI-551;Biological: Placebo;Other: Placebo	MedImmune LLC	NULL	Completed	18 Years	N/A	Both	50	Phase 1	United States;Canada;United Kingdom
199	NCT01117298 (ClinicalTrials.gov)	November 2009	3/5/2010	A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma	A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study	Raynaud's Phenomenon;Digital Ulcers;Scleroderma	Drug: Tadalafil;Drug: Placebo	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Institute of Postgraduate Medical Education and Research;Postgraduate Institute of Medical Education and Research;Army Research and Referral hospital	Completed	18 Years	65 Years	Both	66	Phase 3	India
200	NCT00883129 (ClinicalTrials.gov)	September 2009	16/4/2009	Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)	Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)	Scleroderma;Interstitial Lung Disease	Drug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: Placebo	Michael Roth	National Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La Roche	Completed	18 Years	N/A	All	142	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	EUCTR2007-002015-38-IT (EUCTR)	05/06/2009	19/06/2009	Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND	Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND	Skin Fibrosis in patients with systemic sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma	Product Name: P144	ISDIN S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Phase 2	Hungary;Germany;United Kingdom;Spain;Italy
202	NCT00775463 (ClinicalTrials.gov)	May 2009	17/10/2008	Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine	DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study	Systemic Sclerosis;Scleroderma	Drug: treprostinil diethanolamine;Drug: placebo	United Therapeutics	NULL	Completed	18 Years	N/A	All	148	Phase 2	United States;Canada;United Kingdom
203	EUCTR2007-003621-24-AT (EUCTR)	30/03/2009	23/04/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
204	EUCTR2008-005018-39-GB (EUCTR)	05/03/2009	22/05/2009	DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1	DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1	Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma	Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C-SR INN or Proposed INN: treprostinil diethanolamine	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	150		United Kingdom
205	EUCTR2007-003621-24-GB (EUCTR)	02/12/2008	14/07/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension		MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	NCT00769028 (ClinicalTrials.gov)	December 2008	7/10/2008	AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis	A Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis	Systemic Sclerosis	Drug: Hyperimmune caprine serum;Drug: Albumin	Daval International Limited	NULL	Active, not recruiting	18 Years	N/A	Both	20	Phase 2	United Kingdom
207	NCT00442611 (ClinicalTrials.gov)	November 2008	1/3/2007	A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)	A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic Sclerosis	Scleroderma, Diffuse;Scleroderma, Systemic	Drug: Abatacept;Drug: Placebo	Stanford University	Bristol-Myers Squibb	Completed	18 Years	N/A	All	10	Phase 1;Phase 2	United States
208	NCT00984932 (ClinicalTrials.gov)	September 2008	24/9/2009	Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension	The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial	Systemic Sclerosis	Drug: Rosuvastatin	Faculty of Medicine, University of Alexandria	NULL	Completed	N/A	N/A	Both	40	Phase 3	Egypt
209	EUCTR2007-003621-24-NL (EUCTR)	23/07/2008	13/03/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
210	EUCTR2007-003621-24-IT (EUCTR)	15/07/2008	17/11/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil	MONDOGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	EUCTR2007-003621-24-BE (EUCTR)	20/06/2008	08/01/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
212	EUCTR2007-003621-24-FR (EUCTR)	29/05/2008	27/12/2007	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
213	EUCTR2007-003122-24-GB (EUCTR)	09/04/2008	15/02/2008	A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis	A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis	Diffuse Cutaneous Systemic Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis MedDRA version: 9.1;Classification code 10036814;Term: Progressive systemic sclerosis MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma MedDRA version: 9.1;Classification code 10012941;Term: Diffuse scleroderma MedDRA version: 9.1;Classification code 10018124;Term: Generalized scleroderma MedDRA version: 9.1;Classification code 10042954;Term: Systemic sclerosis pulmonary		Daval International Limited	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	United Kingdom
214	NCT01545427 (ClinicalTrials.gov)	April 2008	1/3/2012	Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma	A Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma	Scleroderma	Drug: Imatinib mesylate;Other: Placebo	Lawson Health Research Institute	Novartis Pharmaceuticals	Terminated	18 Years	N/A	Both	10	Phase 2	Canada
215	EUCTR2007-003621-24-DE (EUCTR)	20/03/2008	13/02/2009	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	EUCTR2007-002015-38-DE (EUCTR)	20/12/2007	03/08/2007	PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS.	PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS.	SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma	Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM	ISDIN	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	Hungary;Spain;Germany;Italy;United Kingdom
217	EUCTR2007-002015-38-GB (EUCTR)	19/12/2007	31/07/2007	PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS.	PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS.	SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma		ISDIN	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	Hungary;Spain;Germany;Italy;United Kingdom
218	NCT00577304 (ClinicalTrials.gov)	December 2007	18/12/2007	A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon	A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon	Raynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Other Autoimmune Disease	Drug: Nitroglycerin;Drug: Topical AmphiMatrix	MediQuest Therapeutics	NULL	Active, not recruiting	15 Years	70 Years	Both	200	Phase 3	United States
219	NCT00581997 (ClinicalTrials.gov)	December 2007	21/12/2007	QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis	A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis	Pulmonary Fibrosis Secondary to Systemic Sclerosis	Drug: QAX576;Drug: Placebo	Novartis Pharmaceuticals	NULL	Terminated	18 Years	65 Years	Both	8	Phase 2	United States
220	NCT00479934 (ClinicalTrials.gov)	December 2007	29/5/2007	Efficacy and Safety of Imatinib in Scleroderma	Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement.	Scleroderma, Localized;Scleroderma, Systemic	Drug: imatinib mesylate	University Hospital, Bordeaux	Ministry of Health, France;Novartis	Completed	18 Years	N/A	Both	28	Phase 2	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	EUCTR2007-002015-38-HU (EUCTR)	04/09/2007	09/07/2007	Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.	Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.	SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma	Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM	ISDIN	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	Hungary;Germany;United Kingdom;Spain;Italy
222	NCT00574613 (ClinicalTrials.gov)	September 2007	13/12/2007	Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis	Phase II, Multicenter, Randomized, Double-blind, Intraindividually Placebo Controlled Clinical Trial, to Evaluate Efficacy and Safety of p144 Topical Administration for Skin Fibrosis in Patients With Systemic Sclerosis	Skin Fibrosis	Drug: P144;Drug: placebo	ISDIN	Digna Biotech S.L.	Completed	18 Years	65 Years	Both	56	Phase 2	Germany;Hungary;Italy;Poland;Spain;United Kingdom
223	EUCTR2007-002015-38-ES (EUCTR)	23/08/2007	02/07/2007	ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS	ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS	FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma	Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM	ISDIN	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Phase 2	Hungary;Germany;United Kingdom;Spain;Italy
224	NCT00419419 (ClinicalTrials.gov)	December 2006	4/1/2007	Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon	Phase III In-Life Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon	Raynaud's Disease;Scleroderma;Autoimmune Diseases	Drug: Topical AmphiMatrix with nitroglycerin (MQX-503)	MediQuest Therapeutics	NULL	Completed	18 Years	70 Years	Both	80	Phase 3	United States;Sweden;United Kingdom
225	EUCTR2005-004979-37-GB (EUCTR)	27/11/2006	18/09/2006	Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2	Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2	Moderate to severe primary Raynaud’s, OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma		MediQuest Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	EUCTR2005-004979-37-SE (EUCTR)	27/10/2006	08/09/2006	Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2	Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2	Moderate to severe primary Raynaud’s,OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma	Product Name: MQX-503 Product Code: MQX-503 INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP Other descriptive name: Nitroglycerine gel	MediQuest Therapeutics, Inc.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United Kingdom;Sweden
227	NCT00377455 (ClinicalTrials.gov)	September 2006	14/9/2006	Placebo Controlled Trial of Bosentan in Scleroderma Patients	Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension	Systemic Scleroderma;Pulmonary Hypertension	Drug: Bosentan;Drug: Placebo	Georgetown University	Actelion	Terminated	18 Years	N/A	All	5	Phase 2	United States
228	NCT00348296 (ClinicalTrials.gov)	July 2006	3/7/2006	Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis	A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis	Scleroderma, Systemic	Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH)	Benesis Corporation	NULL	Completed	16 Years	N/A	Both	60	Phase 3	Japan
229	EUCTR2006-000905-41-AT (EUCTR)	07/06/2006	08/05/2006	Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud	Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud	Raynaud syndrome with / without systemic sclerosis	Trade Name: Ilomedin Product Name: Ilomedin Product Code: 1-22460	ao. Univ. Prof. Dr. Elisabeth Aberer	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Austria
230	NCT00740285 (ClinicalTrials.gov)	April 2004	19/8/2008	Effectiveness and Safety of Lidocaine for Scleroderma	Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial	Scleroderma	Drug: Lidocaine 2% without vessel constrictor;Other: Placebo - physiological solution 0,9%	Federal University of São Paulo	NULL	Completed	18 Years	60 Years	Both	26	Phase 2;Phase 3	Brazil
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	NCT00077584 (ClinicalTrials.gov)	October 2003	10/2/2004	Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma	A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis	Digital Ulcers;Systemic Sclerosis	Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo	Actelion	NULL	Completed	18 Years	N/A	Both	188	Phase 3	United States;Canada
232	NCT02800993 (ClinicalTrials.gov)	October 2003	13/6/2016	Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma	A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis	Systemic Sclerosis;Digital Ulcers	Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo	Actelion	NULL	Completed	18 Years	N/A	Both	188	Phase 3	United States;Canada
233	NCT00070590 (ClinicalTrials.gov)	July 2003	6/10/2003	Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma	A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis	Pulmonary Fibrosis;Scleroderma, Systemic	Drug: Bosentan	Actelion	NULL	Completed	18 Years	N/A	Both	132	Phase 2;Phase 3	United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom
234	NCT00043706 (ClinicalTrials.gov)	May 2002	12/8/2002	Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis	A Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis	Systemic Sclerosis;Scleroderma	Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody	Genzyme, a Sanofi Company	Cambridge Antibody Technology	Completed	18 Years	75 Years	Both		Phase 1;Phase 2	United States
235	NCT00707187 (ClinicalTrials.gov)	July 2001	25/6/2008	Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction	Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis	Systemic Sclerosis	Drug: Cialis	University of Medicine and Dentistry of New Jersey	NULL	Completed	18 Years	N/A	Female	120	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	NCT00418132 (ClinicalTrials.gov)	August 2000	3/1/2007	Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis	T Cell Immunity in Collagen Biosynthesis of Scleroderma	Scleroderma, Systemic	Drug: Thalidomide;Drug: Placebo thalidomide	New York University School of Medicine	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Terminated	18 Years	65 Years	Both	30	Phase 1	United States
237	NCT00005675 (ClinicalTrials.gov)	April 2000	26/5/2000	Oral Type I Collagen for Relieving Scleroderma	Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma	Scleroderma;Connective Tissue Diseases	Drug: Oral bovine type I collagen;Drug: Placebo	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Wayne State University;University of California, Los Angeles;UTHSC;MUSC;Beth Israel Medical Center;University of Alabama at Birmingham;Johns Hopkins University;Georgetown University;Baltimore VA Medical Center;Northwestern University	Completed	18 Years	N/A	Both	168	Phase 2	United States
238	NCT00004563 (ClinicalTrials.gov)	August 1999	9/2/2000	Scleroderma Lung Disease	Cyclophosphamide Versus Placebo in Scleroderma Lung Study	Lung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, Systemic	Drug: Cyclophosphamide;Drug: Placebo	The University of Texas Health Science Center, Houston	National Heart, Lung, and Blood Institute (NHLBI)	Completed	18 Years	N/A	All	158	Phase 3	NULL
239	NCT00704665 (ClinicalTrials.gov)	December 1998	23/6/2008	Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma	A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma	Systemic Sclerosis	Drug: Relaxin	University of Medicine and Dentistry of New Jersey	University of California, Los Angeles;Boston University;University of Chicago;University of Connecticut Health Center;Johns Hopkins University;University of Pittsburgh;Medical University of South Carolina;Stanford University;Georgetown University;University of California, San Diego;Wayne State University;University of Colorado, Denver;Medical College of Wisconsin	Completed	18 Years	70 Years	Both	231	Phase 3	NULL
240	NCT00004786 (ClinicalTrials.gov)	December 1995	24/2/2000	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis		Systemic Sclerosis;Raynaud Disease	Drug: iloprost	National Center for Research Resources (NCRR)	University of Pittsburgh	Completed	18 Years	N/A	Both	200	Phase 3	NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04647890
(ClinicalTrials.gov)

February 2021

16/11/2020

Effects of FT011 in Systemic Sclerosis

A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis

Scleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, Systemic

Drug: FT011;Drug: Placebo

Certa Therapeutics

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 2

NULL

NCT04515706
(ClinicalTrials.gov)

January 1, 2021

13/8/2020

Iguratimod in Systemic Sclerosis

Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis

Systemic Sclerosis, Diffuse

Drug: Iguratimod;Drug: Placebo

RenJi Hospital

NULL

Not yet recruiting

19 Years

74 Years

All

N/A

NULL

NCT04440592
(ClinicalTrials.gov)

December 31, 2020

17/6/2020

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Diffuse Cutaneous Systemic Sclerosis

Drug: MT-7117;Drug: Placebo

Mitsubishi Tanabe Pharma Development America, Inc.

NULL

Recruiting

18 Years

75 Years

All

Phase 2

United States

EUCTR2020-000134-17-GB
(EUCTR)

23/12/2020

05/08/2020

A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis

Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Dersimelagon
Product Code: MT-7117
INN or Proposed INN: Dersimelagon
Other descriptive name: MT-7117

Mitsubishi Tanabe Pharma Development America (MTDA), Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom

EUCTR2020-002081-13-NL
(EUCTR)

02/11/2020

17/08/2020

A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).

A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc)

Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248

Gesynta Pharma AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04478994
(ClinicalTrials.gov)

November 2020

16/7/2020

A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis

Diffuse Cutaneous Systemic Sclerosis

Biological: TEPEZZA;Other: Placebo

Horizon Therapeutics USA, Inc.

NULL

Recruiting

18 Years

80 Years

All

Phase 1

United States

NCT04356287
(ClinicalTrials.gov)

October 2020

15/4/2020

Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis

Phase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic Sclerosis

Sclerosis, Systemic;Mesenchymal Stem Cells

Biological: UCMSC;Other: Placebo

Marie Hudson, MD

Assistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health Centre

Not yet recruiting

18 Years

N/A

All

Phase 1;Phase 2

NULL

NCT04300426
(ClinicalTrials.gov)

September 24, 2020

25/2/2020

Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)

Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week Study

Systemic Sclerosis

Drug: ACHIM as solute (10^9 intestinal microbes/ml)

Oslo University Hospital

South-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North Norway

Recruiting

18 Years

85 Years

All

Phase 2

Norway

NCT04356755
(ClinicalTrials.gov)

September 22, 2020

11/3/2020

Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.

Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma

Systemic Sclerosis

Procedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: Placebo

University Hospital, Toulouse

NULL

Recruiting

18 Years

N/A

All

Phase 2

France

EUCTR2020-002081-13-GB
(EUCTR)

08/09/2020

21/07/2020

A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).

Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248

Gesynta Pharma AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000906-31-DE
(EUCTR)

01/07/2020

31/10/2019

Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)

A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis

efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN

CSL Behring GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 2

United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany

NCT04166552
(ClinicalTrials.gov)

June 11, 2020

6/11/2019

Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis

A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic Sclerosis

Diffuse Cutaneous Systemic Sclerosis

Drug: Patients will be randomized to receive EHP-101 or Placebo

Emerald Health Pharmaceuticals Inc.

Iqvia Pty Ltd

Recruiting

18 Years

70 Years

All

Phase 2

United States;Australia;New Zealand

EUCTR2019-000906-31-GB
(EUCTR)

22/05/2020

29/10/2019

Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)

CSL Behring GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 2

United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany

NCT04200755
(ClinicalTrials.gov)

May 19, 2020

10/12/2019

Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma

A Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized Scleroderma

Localized Scleroderma

Drug: Dupilumab 300Mg Solution for Injection;Other: Placebo

University of Cologne

NULL

Recruiting

18 Years

N/A

All

Phase 2

Germany

EUCTR2019-000906-31-PL
(EUCTR)

31/01/2020

06/12/2019

Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)

CSL Behring GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 2

United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04388176
(ClinicalTrials.gov)

January 3, 2020

11/5/2020

Cold Challenge With C21 in RP

A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)

Raynaud Phenomenon;Systemic Sclerosis

Drug: C21;Drug: Placebo

Vicore Pharma AB

SGS Life Sciences, a division of SGS Belgium NV

Recruiting

19 Years

75 Years

All

Phase 2

United Kingdom

NCT04138485
(ClinicalTrials.gov)

December 20, 2019

14/10/2019

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Diffuse Cutaneous Systemic Sclerosis

Biological: IgPro10;Biological: Placebo

CSL Behring

NULL

Withdrawn

18 Years

N/A

All

Phase 2

United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom

EUCTR2019-000906-31-ES
(EUCTR)

16/12/2019

20/12/2019

Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)

efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

CSL Behring GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

188

Phase 2

United States;Spain;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany

EUCTR2019-003203-35-GB
(EUCTR)

13/12/2019

05/09/2019

A Phase 2, single-center, randomised, double-blind, placebo-controlled, cross-over, cold challenge study investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc)

Systemic sclerosis (SSc)Raynaud’s phenomenon (RP)
MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: NA
Product Code: C21
INN or Proposed INN: NA
Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt

Vicore Pharma AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

EUCTR2019-000906-31-FR
(EUCTR)

03/12/2019

08/11/2019

Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)

CSL Behring GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 2

United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002036-90-DE
(EUCTR)

02/12/2019

02/10/2019

Study to test effectiveness and safety of the drug Dupilumab in patients with localized scleroderma

A randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma - DupiMorph

Localized scleroderma
MedDRA version: 21.1;Level: LLT;Classification code 10009206;Term: Circumscribed scleroderma;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10027979;Term: Morphea;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: Dupilumab
Product Code: Dupilumab
INN or Proposed INN: Dupilumab
Other descriptive name: SAR231893

University of Cologne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

NCT04040322
(ClinicalTrials.gov)

October 14, 2019

30/7/2019

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Drug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous use

Eicos Sciences, Inc.

NULL

Recruiting

18 Years

N/A

All

180

Phase 3

United States

NCT03844061
(ClinicalTrials.gov)

July 29, 2019

31/1/2019

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Systemic Sclerosis

Drug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMF

Hospital for Special Surgery, New York

GlaxoSmithKline

Recruiting

18 Years

80 Years

All

Phase 2

United States

NCT04045743
(ClinicalTrials.gov)

July 19, 2019

27/7/2019

The Benefit of Bermekimab in Patients With Systemic Sclerosis

Clinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)

Scleroderma, Systemic

Drug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab)

Hellenic Institute for the Study of Sepsis

NULL

Recruiting

18 Years

N/A

All

Phase 2

Greece

EUCTR2015-004613-24-BE
(EUCTR)

17/07/2019

18/04/2019

Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.

Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early

(very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Solu-Medrol
Product Name: methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Radboudumc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03919799
(ClinicalTrials.gov)

July 9, 2019

21/11/2018

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic Sclerosis

System; Sclerosis;Diffuse Cutaneous Systemic Sclerosis

Drug: Belumosudil (KD025);Drug: Placebo

Kadmon Corporation, LLC

NULL

Recruiting

18 Years

100 Years

All

Phase 2

United States

NCT04036227
(ClinicalTrials.gov)

July 3, 2019

23/7/2019

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248

A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)

Healthy

Drug: GS-248;Drug: Placebo

Gesynta Pharma AB

CTC Clinical Trial Consultants

Completed

18 Years

75 Years

All

Phase 1

Sweden

JPRN-JapicCTI-194761

23/5/2019

17/05/2019

A Phase 3 study of KHK4827 in patients with systemic sclerosis

A Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickening

Systemic sclerosis

Intervention name : KHK4827
INN of the intervention : Brodalumab
Dosage And administration of the intervention : 210 mg Q2W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 210 mg Q2W, SC

Kyowa Kirin Co., Ltd.

NULL

complete

BOTH

100

Phase 3

Japan

NCT03957681
(ClinicalTrials.gov)

May 23, 2019

16/5/2019

A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

A Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin Thickening

Moderate to Severe Systemic Sclerosis

Drug: KHK4827;Drug: Placebo

Kyowa Kirin Co., Ltd.

NULL

Active, not recruiting

18 Years

70 Years

All

100

Phase 3

Japan

EUCTR2018-001817-33-BE
(EUCTR)

05/04/2019

23/01/2019

A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis

A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis

Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Spain;Belgium;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-001817-33-DE
(EUCTR)

29/03/2019

23/01/2019

A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis

Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Belgium;Spain;Germany;Italy;United Kingdom

NCT03867097
(ClinicalTrials.gov)

March 4, 2019

6/3/2019

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis

Raynaud Phenomenon Secondary to Systemic Sclerosis

Drug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous use

Eicos Sciences, Inc.

NULL

Completed

18 Years

N/A

All

Phase 2

United States

EUCTR2018-001817-33-GB
(EUCTR)

14/01/2019

20/11/2018

A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis

Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Spain;Belgium;Germany;Italy;United Kingdom

NCT03798366
(ClinicalTrials.gov)

January 14, 2019

3/1/2019

A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis

A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis

Scleroderma

Drug: GLPG1690;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Belgium;Germany;Italy;Spain;United Kingdom

NCT03817424
(ClinicalTrials.gov)

December 13, 2018

22/1/2019

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis

Drug: VIB7734;Drug: Placebo

Viela Bio

NULL

Completed

18 Years

75 Years

All

Phase 1

United States;Poland;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03211793
(ClinicalTrials.gov)

November 2018

27/4/2017

Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial

Systemic Sclerosis;Digital Ulcer

Drug: Mesenchymal stromal cells;Other: Placebo

UMC Utrecht

ZonMw: The Netherlands Organisation for Health Research and Development

Unknown status

18 Years

N/A

All

Phase 1;Phase 2

Netherlands

NCT03717961
(ClinicalTrials.gov)

October 15, 2018

15/10/2018

Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis

Raynaud Phenomenon Secondary to Systemic Sclerosis

Drug: BOTOX ® solution;Drug: Placebo group

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

N/A

All

Phase 3

France

EUCTR2017-000372-29-PL
(EUCTR)

28/09/2018

02/07/2018

A study of safety and efficacy of lenabasum in Systemic Sclerosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis

Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum

Corbus Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

354

Phase 3

United States;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of

EUCTR2016-003417-95-NL
(EUCTR)

18/09/2018

09/07/2018

Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.

A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.

Product Name: GSK2330811 Solution for Injection, 100mg/ml
Product Code: GSK2330811
INN or Proposed INN: GSK2330811
Other descriptive name: GSK2330811

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Netherlands;United Kingdom

NCT03558854
(ClinicalTrials.gov)

August 28, 2018

3/5/2018

Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients

Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis

Systemic Sclerosis

Drug: Acetylsalicylic acid;Drug: Placebo oral capsule

Federal University of São Paulo

NULL

Recruiting

18 Years

65 Years

All

Phase 4

Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-000372-29-NL
(EUCTR)

21/06/2018

24/01/2018

A study of safety and efficacy of lenabasum in Systemic Sclerosis

Corbus pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

354

Phase 3

United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of

NCT03856853
(ClinicalTrials.gov)

June 15, 2018

26/2/2019

Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease

A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)

Drug: Pirfenidone;Other: placebo

Beijing Continent Pharmaceutical Co, Ltd.

Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group)

Recruiting

18 Years

75 Years

All

144

Phase 3

China

EUCTR2017-000372-29-ES
(EUCTR)

25/04/2018

02/02/2018

A study of safety and efficacy of lenabasum in Systemic Sclerosis

Systemic Sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Lenabasum 5 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum

Corbus pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

354

Phase 3

United States;Spain;Israel;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of

EUCTR2017-000372-29-GB
(EUCTR)

20/03/2018

07/12/2017

A study of safety and efficacy of lenabasum in Systemic Sclerosis

Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

Corbus pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

354

Phase 3

United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of

EUCTR2017-000372-29-DE
(EUCTR)

07/03/2018

13/12/2017

A study of safety and efficacy of lenabasum in Systemic Sclerosis

Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

Corbus pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

354

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03708718
(ClinicalTrials.gov)

December 21, 2017

8/10/2018

Prednisolone in Early Diffuse Systemic Sclerosis

A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)

Systemic Sclerosis

Drug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'

Prof. Ariane herrick

Versus Arthritis

Recruiting

18 Years

N/A

All

Phase 2

United Kingdom

NCT03398837
(ClinicalTrials.gov)

December 18, 2017

5/1/2018

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Diffuse Cutaneous Systemic Sclerosis

Drug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsule

Corbus Pharmaceuticals Inc.

NULL

Active, not recruiting

18 Years

N/A

All

365

Phase 3

United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom

NCT04274257
(ClinicalTrials.gov)

December 4, 2017

13/2/2020

A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis

Double-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic Sclerosis

Scleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen Diseases

Drug: Double-Blind Placebo;Drug: Double-Blind Rituximab

Tokyo University

Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.

Completed

20 Years

80 Years

All

Phase 2;Phase 3

Japan

NCT03221257
(ClinicalTrials.gov)

November 28, 2017

12/7/2017

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease

Scleroderma, Systemic;Interstitial Lung Disease

Drug: Pirfenidone (PFD);Drug: Placebo (Plac);Drug: Mycophenolate Mofetil (MMF)

Michael Roth

University of Michigan;Genentech, Inc.;University of California, Los Angeles

Active, not recruiting

18 Years

N/A

All

150

Phase 2

United States

NCT03274076
(ClinicalTrials.gov)

September 25, 2017

28/8/2017

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability Study

Systemic Sclerosis;Scleroderma

Drug: Tofacitinib;Drug: Placebo Oral Tablet

University of Michigan

Pfizer

Completed

18 Years

70 Years

All

Phase 1;Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03222492
(ClinicalTrials.gov)

September 20, 2017

17/7/2017

Brentuximab Vedotin for Systemic Sclerosis

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)

Diffuse Cutaneous Systemic Sclerosis;Scleroderma;dcSSc

Biological: Brentuximab Vedotin;Biological: Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Immune Tolerance Network (ITN);Seagen Inc.

Recruiting

18 Years

70 Years

All

Phase 1;Phase 2

United States;Canada

EUCTR2015-001617-27-BG
(EUCTR)

02/08/2017

17/05/2017

A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Inventiva SA

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland

EUCTR2015-000392-28-CZ
(EUCTR)

27/06/2017

27/04/2017

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Not Recruiting

Female: yes
Male: yes

520

Phase 3

Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden

NCT03120533
(ClinicalTrials.gov)

June 20, 2017

23/3/2017

Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study

Therapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study

Scleroderma, Systemic

Drug: Iontophoresis of treprostinil;Drug: Iontophoresis of placebo

University Hospital, Grenoble

Linksium;University Grenoble Alps

Completed

18 Years

N/A

All

Phase 1;Phase 2

France

EUCTR2015-000392-28-HU
(EUCTR)

08/06/2017

26/04/2017

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03041025
(ClinicalTrials.gov)

June 5, 2017

31/1/2017

Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis

A Multi-center, Randomized, Double-blind (Sponsor Open), Placebo-controlled, Repeat-dose, Proof of Mechanism Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Explore Efficacy of GSK2330811 in Participants With Diffuse Cutaneous Systemic Sclerosis

Scleroderma, Systemic

Drug: GSK2330811;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Canada;Netherlands;United Kingdom

EUCTR2015-000392-28-NO
(EUCTR)

02/06/2017

15/02/2017

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim Norway KS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden

EUCTR2015-001617-27-SI
(EUCTR)

26/05/2017

15/05/2017

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Inventiva SA

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland

EUCTR2015-000392-28-AT
(EUCTR)

12/05/2017

31/03/2017

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Boehringer Ingelheim RCV GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia

EUCTR2015-000392-28-SE
(EUCTR)

08/05/2017

24/02/2017

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Boehringer Ingelheim AB

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03068234
(ClinicalTrials.gov)

May 2017

16/2/2017

Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis

Systemic Sclerosis

Drug: Pirfenidone;Drug: Placebo oral capsule;Drug: Steroids

RenJi Hospital

NULL

Not yet recruiting

18 Years

70 Years

All

Phase 2;Phase 3

China

EUCTR2015-000392-28-FI
(EUCTR)

21/02/2017

10/02/2017

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Boehringer Ingelheim Finland Ky

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

EUCTR2015-002586-39-BE
(EUCTR)

19/01/2017

14/07/2016

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS

Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE

medac GmbH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

Switzerland;Italy;United Kingdom;Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany

EUCTR2016-003417-95-GB
(EUCTR)

13/01/2017

24/10/2016

Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.

Systemic sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: GSK2330811 Solution for Injection, 100mg/ml
Product Code: GSK2330811
INN or Proposed INN: GSK2330811
Other descriptive name: GSK2330811

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Netherlands;United Kingdom

NCT03059979
(ClinicalTrials.gov)

January 2017

25/1/2017

The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )

Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.

Systemic Sclerosis;Raynaud Phenomena

Drug: Methylprednisolone;Other: sodium chloride

Radboud University

NULL

Recruiting

18 Years

N/A

All

Early Phase 1

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02682511
(ClinicalTrials.gov)

January 2017

8/2/2016

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)

Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune Diseases

Drug: Oral Ifetroban;Drug: Oral Placebo

Cumberland Pharmaceuticals

NULL

Recruiting

18 Years

80 Years

All

Phase 2

United States;India

EUCTR2016-001028-80-IT
(EUCTR)

19/12/2016

05/11/2020

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study - NA

Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: NA
Product Code: SAR156597
INN or Proposed INN: non applicabile

SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Romania;Germany

JPRN-UMIN000024818

2016/12/12

14/11/2016

The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis

The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis - The efficacy and safety of BTX-B on digital ulcers in patients with SSc

digital ulcers in systemic sclerosis patients

placebo subcutaneously injection into hands with digital ulcers
botulinum toxin type B subcutaneously injection into hands with digital ulcers

Gunma University Hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not selected

Japan

NCT02981082
(ClinicalTrials.gov)

December 2016

30/11/2016

Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress.

Systemic Sclerosis;Pulmonary; Hypertension

Drug: Dimethyl Fumarate (DMF);Drug: Placebo Oral Tablet

Robert Lafyatis

Biogen

Terminated

18 Years

80 Years

All

Phase 1

United States

NCT03053739
(ClinicalTrials.gov)

December 2016

29/12/2016

To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis

Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis

Associated Pulmonary Arterial Hypertension

Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo

Postgraduate Institute of Medical Education and Research

NULL

Recruiting

18 Years

N/A

All

Phase 4

India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02921971
(ClinicalTrials.gov)

November 23, 2016

30/9/2016

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study

Systemic Sclerosis

Drug: SAR156597 (ACT14604);Drug: Placebo

Sanofi

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria

EUCTR2016-001028-80-DE
(EUCTR)

08/11/2016

18/07/2016

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study

Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: SAR156597

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany

EUCTR2015-002586-39-GB
(EUCTR)

18/10/2016

19/07/2016

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS

Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE

medac GmbH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;Switzerland;United Kingdom

EUCTR2015-000424-28-IE
(EUCTR)

17/10/2016

19/08/2016

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan

EUCTR2016-001028-80-EE
(EUCTR)

04/10/2016

20/09/2016

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study

Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-002586-39-PT
(EUCTR)

03/10/2016

06/07/2016

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS

Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE

medac GmbH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

France;United States;Portugal;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland

NCT02896205
(ClinicalTrials.gov)

October 2016

27/8/2016

Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease

A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease

Systemic Sclerosis;Scleroderma;Interstitial Lung Disease

Drug: Mycophenolate mofetil;Drug: Placebo

Postgraduate Institute of Medical Education and Research

NULL

Completed

18 Years

N/A

All

Phase 3

India

EUCTR2016-001028-80-AT
(EUCTR)

30/09/2016

27/07/2016

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study

Systemic sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany

EUCTR2016-001028-80-BE
(EUCTR)

26/09/2016

02/08/2016

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany

EUCTR2015-002586-39-HU
(EUCTR)

20/09/2016

12/07/2016

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS

Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

medac GmbH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-002586-39-FR
(EUCTR)

13/09/2016

21/07/2016

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS

Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE

medac GmbH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

Portugal;United States;France;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland

NCT02915835
(ClinicalTrials.gov)

September 2016

15/9/2016

Riociguat in Scleroderma Associated Digital Ulcers

A Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital Ulcers

Scleroderma;Digital Ulcers

Drug: Riociguat;Drug: Placebo

Dinesh Khanna, MD, MS

Bayer

Completed

18 Years

N/A

All

Phase 2

United States

EUCTR2015-005023-11-IT
(EUCTR)

29/08/2016

23/02/2018

Abituzumab in SSc-ILD

A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Abituzumab
Product Code: EMD 525797
INN or Proposed INN: abituzumab

MERCK KGAA

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;United Kingdom;Italy

EUCTR2015-002586-39-DE
(EUCTR)

03/08/2016

29/06/2016

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS

Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE

medac GmbH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland

EUCTR2015-002586-39-IT
(EUCTR)

27/07/2016

06/02/2018

Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis

Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
Product Name: Metoclopramide
Product Code: /
INN or Proposed INN: METOCLOPRAMIDE
Other descriptive name: METOCLOPRAMIDE

MEDAC GMBH

NULL

Not Recruiting

Female: yes
Male: yes

148

Phase 3

Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-005023-11-PL
(EUCTR)

12/07/2016

20/06/2016

Abituzumab in SSc-ILD

Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

France;United States;Canada;Argentina;Spain;Poland;Singapore;Turkey;Australia;Israel;Italy;United Kingdom

EUCTR2015-005023-11-GB
(EUCTR)

08/07/2016

25/05/2016

Abituzumab in SSc-ILD

Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom

EUCTR2015-005023-11-ES
(EUCTR)

04/07/2016

27/06/2016

Abituzumab in SSc-ILD

Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 19.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

175

Phase 2

France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom

EUCTR2015-000392-28-IE
(EUCTR)

27/06/2016

13/04/2016

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

EUCTR2015-001617-27-NL
(EUCTR)

07/06/2016

06/04/2016

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID

Inventiva SAS

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Slovenia;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02745145
(ClinicalTrials.gov)

May 31, 2016

15/4/2016

Abituzumab in SSc-ILD

A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

Systemic Sclerosis-associated Interstitial Lung Disease

Drug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: Placebo

EMD Serono Research & Development Institute, Inc.

Merck KGaA, Darmstadt, Germany

Terminated

18 Years

75 Years

All

Phase 2

United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey

EUCTR2015-004613-24-NL
(EUCTR)

30/05/2016

13/04/2016

Hit hard and early

Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized double-blind placebo-controlled trial. - Hit hard and early

(very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: methylprednisolon
INN or Proposed INN: methylprednisolon
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Radboudumc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

EUCTR2015-000392-28-PL
(EUCTR)

09/03/2016

21/01/2016

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Boehringer-Ingelheim RCV GmbH&Co KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

NCT02370693
(ClinicalTrials.gov)

March 2016

11/2/2015

Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis

Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558

Interstitial Lung Disease;ILD;Systemic Sclerosis;Scleroderma

Drug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetil

Northwestern University

National Heart, Lung, and Blood Institute (NHLBI)

Recruiting

18 Years

N/A

All

Phase 2

United States

NCT02588625
(ClinicalTrials.gov)

February 2016

26/10/2015

A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Scleroderma

Drug: BMS-986020;Other: Placebo

Bristol-Myers Squibb

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

United States;Canada;Poland;United Kingdom;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-000424-28-GR
(EUCTR)

26/01/2016

30/12/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan

JPRN-JapicCTI-152963

08/1/2016

09/07/2015

Phase III Study of Tocilizumab in Patients with Systemic Sclerosis

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis

Intervention name : Tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo/W, SC

Chugai Pharmaceutical Co., Ltd.

F.Hoffmann-La Roche Ltd

complete

BOTH

210

Phase 3

Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.

EUCTR2015-000392-28-PT
(EUCTR)

08/01/2016

14/09/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Unilfarma - União Internacional de Lab. Farmacêuticos, Lda

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden

NCT02530996
(ClinicalTrials.gov)

January 1, 2016

29/7/2015

Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment

Rheumatologic Disease

Drug: BH4;Other: Vasculopathy assessment;Drug: Placebo

VA Office of Research and Development

NULL

Completed

18 Years

95 Years

All

United States

100

NCT03141125
(ClinicalTrials.gov)

January 2016

20/6/2016

The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy

The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and Fibrosis

Scleroderma

Other: Physalis angulata ethanol extract;Other: Placebo

Indonesia University

Netherlands: Ministry of Health, Welfare and Sports

Completed

18 Years

60 Years

All

N/A

Indonesia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2015-000424-28-NL
(EUCTR)

22/12/2015

21/09/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

102

EUCTR2015-000424-28-HR
(EUCTR)

18/12/2015

01/02/2016

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 3

Portugal;United States;Greece;Spain;Lithuania;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Japan

103

EUCTR2015-000392-28-FR
(EUCTR)

11/12/2015

14/12/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim France

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden

104

EUCTR2015-000392-28-BE
(EUCTR)

08/12/2015

25/09/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

SCS Boehringer Ingelheim Comm. V

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

520

Phase 3

105

NCT02453256
(ClinicalTrials.gov)

November 20, 2015

21/5/2015

A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

Systemic Sclerosis

Drug: Placebo;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

212

Phase 3

United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2015-000392-28-ES
(EUCTR)

19/11/2015

05/10/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim España, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

107

EUCTR2015-000392-28-GR
(EUCTR)

18/11/2015

22/10/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim Ellas SA

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

108

NCT02597933
(ClinicalTrials.gov)

November 12, 2015

8/10/2015

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

Scleroderma, Systemic

Drug: Nintedanib;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

N/A

All

580

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom

109

EUCTR2015-000392-28-DE
(EUCTR)

11/11/2015

25/08/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

110

EUCTR2015-000392-28-GB
(EUCTR)

10/11/2015

01/09/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2015-000392-28-NL
(EUCTR)

02/11/2015

24/08/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer Ingelheim bv

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

112

NCT03531216
(ClinicalTrials.gov)

November 2, 2015

9/5/2018

Topical Rosemary Oil Application in Systemic Sclerosis

Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial

Systemic Sclerosis

Other: Rosemary essential oil;Other: Placebo

ARCIM Institute Academic Research in Complementary and Integrative Medicine

University Hospital Tuebingen

Completed

18 Years

N/A

All

N/A

Germany

113

EUCTR2015-000424-28-DE
(EUCTR)

02/11/2015

27/07/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan

114

NCT02503644
(ClinicalTrials.gov)

October 29, 2015

30/6/2015

Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis

A Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic Sclerosis

Scleroderma, Diffuse;Diffuse Cutaneous Systemic Sclerosis

Drug: IVA337;Drug: Placebo

Inventiva Pharma

NULL

Completed

18 Years

75 Years

All

145

Phase 2

Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom

115

EUCTR2015-001617-27-DE
(EUCTR)

23/10/2015

28/08/2015

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Inventiva SA

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

EUCTR2015-000424-28-LT
(EUCTR)

14/10/2015

29/07/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

117

EUCTR2015-000392-28-DK
(EUCTR)

22/09/2015

A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis

Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Boehringer-Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

118

EUCTR2015-000424-28-HU
(EUCTR)

22/09/2015

11/08/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

119

EUCTR2015-001617-27-IT
(EUCTR)

18/09/2015

17/06/2015

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID

Inventiva SAS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

105

Phase 2

Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy

120

EUCTR2014-005323-27-GB
(EUCTR)

16/09/2015

29/09/2015

A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosis

A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial - The Abatacept Systemic SclErosis Trial (ASSET)

Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 18.0;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

University of Michigan

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

EUCTR2015-001617-27-GB
(EUCTR)

16/09/2015

17/07/2015

A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc) - IVA337 SSc POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 19.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Inventiva SA

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 2

Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom

122

EUCTR2015-000424-28-DK
(EUCTR)

10/09/2015

17/07/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

123

EUCTR2015-001617-27-ES
(EUCTR)

08/09/2015

10/07/2015

A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. - IVA337 SSC POC

Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID

Inventiva SAS

NULL

Not Recruiting

Female: yes
Male: yes

105

Phase 2

Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland

124

EUCTR2015-000424-28-BE
(EUCTR)

07/09/2015

28/07/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

125

NCT02551042
(ClinicalTrials.gov)

September 2015

17/12/2014

CSL Behring Sclero XIII

A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis

Systemic Sclerosis

Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chloride

University College, London

CSL Behring

Recruiting

18 Years

N/A

Both

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2015-000424-28-ES
(EUCTR)

07/08/2015

04/08/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

127

NCT02465437
(ClinicalTrials.gov)

August 2015

4/6/2015

Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis

Diffuse Cutaneous Systemic Sclerosis

Drug: JBT-101;Drug: Placebo;Drug: Part B Open-Label Extension

Corbus Pharmaceuticals Inc.

NULL

Active, not recruiting

18 Years

70 Years

All

Phase 2

United States

128

EUCTR2015-000424-28-PT
(EUCTR)

31/07/2015

30/07/2015

A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 3

Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan

129

NCT02349009
(ClinicalTrials.gov)

June 2015

18/1/2015

Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial

A Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial

Systemic Scleroderma

Drug: C-82 Topical Gel, 1%;Drug: C-82 Topical Gel, Placebo

Prism Pharma Co., Ltd.

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

130

NCT02386436
(ClinicalTrials.gov)

April 21, 2015

6/3/2015

A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects

A Phase I, Randomised, Double-blind (Sponsor Open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy Subjects

Scleroderma, Systemic

Drug: GSK2330811;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

65 Years

All

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2014-001353-16-GB
(EUCTR)

17/04/2015

03/10/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 m

Bayer AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan

132

EUCTR2014-001101-40-GB
(EUCTR)

24/02/2015

14/01/2015

Investigation of safety and therapeutic effect of Fibrogammin® in Scleroderma

Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII

Systemic Sclerosis
MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859
MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

University College London (UCL)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

133

EUCTR2014-001353-16-DE
(EUCTR)

19/02/2015

16/10/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Bayer AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan

134

NCT02370784
(ClinicalTrials.gov)

February 2015

26/1/2015

Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma

The Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic Sclerosis

Scleroderma

Drug: atorvastatin;Drug: Placebo

Robyn T. Domsic, MD, MPH

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Completed

18 Years

70 Years

All

Phase 2

United States

135

EUCTR2014-001353-16-CZ
(EUCTR)

22/01/2015

06/11/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Bayer AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

EUCTR2014-001353-16-IT
(EUCTR)

19/01/2015

14/05/2015

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan

137

NCT02283762
(ClinicalTrials.gov)

January 15, 2015

3/11/2014

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Scleroderma, Systemic

Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo

Bayer

NULL

Completed

18 Years

N/A

All

121

Phase 2

United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain

138

NCT02165111
(ClinicalTrials.gov)

January 2015

11/6/2014

Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome

A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's Syndrome

Scleroderma;Raynaud's Syndrome

Drug: Onabotulinumtoxin A;Drug: sterile saline solution

Johns Hopkins University

Allergan

Completed

18 Years

N/A

All

Phase 3

United States

139

EUCTR2014-001353-16-NL
(EUCTR)

31/12/2014

20/10/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Bayer AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan

140

EUCTR2014-001353-16-HU
(EUCTR)

30/12/2014

14/11/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2014-001353-16-ES
(EUCTR)

22/12/2014

03/11/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan

142

EUCTR2014-001353-16-BE
(EUCTR)

09/12/2014

21/10/2014

Effectiveness and safety of riociguat in patients with sclerosis of the skin

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Bayer HealthCare AG

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2

United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan

143

NCT02228850
(ClinicalTrials.gov)

November 2014

20/8/2014

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Drug: Alprostadil;Other: Placebo

NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

NULL

Completed

18 Years

79 Years

Both

Phase 2

United States

144

EUCTR2014-000865-34-DE
(EUCTR)

31/10/2014

10/09/2014

A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis

A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis

Raynaud's Phenomenon secondary to Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;United Kingdom

145

NCT02047708
(ClinicalTrials.gov)

October 2014

22/1/2014

Zibotentan Better Renal Scleroderma Outcome Study

A Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to Scleroderma

Scleroderma;Scleroderma Renal Crisis;Chronic Kidney Disease

Drug: Zibotentan

University College, London

Medical Research Council

Completed

18 Years

N/A

All

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

NCT02260557
(ClinicalTrials.gov)

October 2014

6/10/2014

Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Drug: Selexipag;Drug: Placebo

Actelion

NULL

Completed

18 Years

N/A

Both

Phase 2

France;Germany;United Kingdom

147

EUCTR2014-000865-34-GB
(EUCTR)

16/09/2014

10/09/2014

A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis

Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;United Kingdom

148

NCT02161406
(ClinicalTrials.gov)

September 2014

3/6/2014

A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis

A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.

Diffuse Cutaneous Systemic Sclerosis

Drug: Abatacept;Drug: Placebo

Dinesh Khanna, MD, MS

Bristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID)

Completed

18 Years

N/A

All

Phase 2

United States;Canada;United Kingdom

149

NCT02290613
(ClinicalTrials.gov)

July 1, 2014

31/10/2014

Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)

Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA

Systemic Sclerosis;Pulmonary Hypertension

Drug: Ambrisentan;Drug: Placebo

Heidelberg University

GlaxoSmithKline

Completed

18 Years

N/A

All

Phase 2

Germany

150

EUCTR2013-003200-39-GB
(EUCTR)

01/04/2014

04/04/2014

Investigation of Zibotentan for kidney disease in scleroderma

A phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA)

Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease).
MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857
MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

University College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2010-022710-77-CZ
(EUCTR)

06/01/2014

02/02/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis

Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

152

EUCTR2012-004955-35-IT
(EUCTR)

29/07/2013

30/05/2013

A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”

SYSTEMIC SCLEROSIS
MedDRA version: 16.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Mabthera

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

153

NCT01878526
(ClinicalTrials.gov)

June 2013

7/6/2013

Gastroesophageal Reflux Treatment in Scleroderma

The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis

Gastroesophageal Reflux Disease;Systemic Sclerosis;Scleroderma

Drug: Alginic acid;Drug: placebo (for domperidone);Drug: Domperidone;Drug: placebo (of alginic acid)

Khon Kaen University

NULL

Completed

18 Years

65 Years

All

Phase 3

Thailand

154

NCT01804959
(ClinicalTrials.gov)

May 2013

3/3/2013

Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

A Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Systemic Sclerosis

Dietary Supplement: Vivomixx probiotics

Singapore General Hospital

NULL

Unknown status

18 Years

N/A

All

Phase 2

Singapore

155

NCT01748084
(ClinicalTrials.gov)

April 9, 2013

10/12/2012

Rituximab in Systemic Sclerosis

Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis

Systemic Sclerosis

Drug: Rituximab;Drug: Placebo (NaCl)

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

80 Years

All

Phase 2;Phase 3

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

NCT01785056
(ClinicalTrials.gov)

April 2013

28/1/2013

IVIG Treatment in Systemic Sclerosis

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis

Systemic Sclerosis;Diffuse Scleroderma

Biological: Privigen

Georgetown University

CSL Behring

Unknown status

18 Years

N/A

All

N/A

United States

157

EUCTR2012-001369-34-IT
(EUCTR)

12/02/2013

21/12/2012

Proof of biological activity of SAR100842 in Systemic Sclerosis

Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis

Systemic Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: NA
Product Code: SAR100842
Product Name: NA
Product Code: SAR100842

SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Germany;United Kingdom;Switzerland;Italy

158

NCT01570764
(ClinicalTrials.gov)

January 14, 2013

2/4/2012

Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease

Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease

Systemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung Fibrosis

Drug: Cyclophosphamide;Drug: Placebo

Assistance Publique - Hôpitaux de Paris

Hôpital Claude-Huriez

Completed

18 Years

N/A

All

Phase 3

France

159

NCT01651143
(ClinicalTrials.gov)

January 2013

24/7/2012

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

Double-blind, Randomized, Placebo-controlled, 8-week Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

Systemic Sclerosis

Drug: SAR100842;Drug: Placebo

Sanofi

NULL

Completed

18 Years

N/A

Both

Phase 2

United States;France;Italy;Switzerland;United Kingdom;Germany

160

EUCTR2012-001369-34-DE
(EUCTR)

19/11/2012

17/08/2012

Proof of biological activity of SAR100842 in Systemic Sclerosis

Initial title : Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic SclerosisRevised title according to the protocol amendment 4 :Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis

Systemic Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Code: SAR100842
Product Code: SAR100842

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;Canada;Germany;United Kingdom;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2012-001369-34-GB
(EUCTR)

26/10/2012

15/06/2012

Proof of biological activity of SAR100842 in Systemic Sclerosis

Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis

Systemic Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Canada;Germany;Italy;Switzerland;United Kingdom

162

NCT01559129
(ClinicalTrials.gov)

August 9, 2012

19/3/2012

Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease

A Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung Disease

Scleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung Disease

Drug: Pomalidomide (CC-4047);Drug: Placebo

Celgene

NULL

Terminated

18 Years

80 Years

All

Phase 2

United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom

163

NCT01670565
(ClinicalTrials.gov)

August 2012

15/8/2012

Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.

Systemic Sclerosis

Drug: Belimumab

Hospital for Special Surgery, New York

Human Genome Sciences Inc.

Completed

18 Years

N/A

All

Phase 2

United States

164

EUCTR2010-023047-15-PL
(EUCTR)

17/07/2012

14/05/2012

A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease

A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease

systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: Pomalidomide
Product Code: CC -4047
INN or Proposed INN: Pomalidomide

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland

165

EUCTR2010-022969-95-PL
(EUCTR)

30/05/2012

12/03/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

EUCTR2010-022710-77-PL
(EUCTR)

30/05/2012

12/03/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

167

EUCTR2010-022710-77-IT
(EUCTR)

11/04/2012

09/02/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis)

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA

ACTELION PHARMACEUTICALS LTD.

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

168

EUCTR2010-022969-95-GR
(EUCTR)

02/04/2012

28/03/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

169

EUCTR2010-023047-15-IT
(EUCTR)

20/03/2012

28/12/2011

A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease

A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease

Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: Pomalidomide
Product Code: CC -4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide

CELGENE CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Poland;Spain;Australia;Germany;United Kingdom;Italy

170

EUCTR2010-023047-15-DE
(EUCTR)

15/03/2012

08/12/2011

A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease

A Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease

systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

EUCTR2010-023047-15-GB
(EUCTR)

08/03/2012

15/12/2011

A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease

systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom

172

EUCTR2010-023047-15-ES
(EUCTR)

02/03/2012

19/01/2012

A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung disease

diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: Pomalidomida
Product Code: CC -4047
INN or Proposed INN: Pomalidomida

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden

173

NCT01553981
(ClinicalTrials.gov)

March 2012

11/3/2012

A Trial of Tadalafil in Interstitial Lung Disease of Scleroderma

A Double Blind Randomized Control Trial of Tadalafil in Interstitial Lung Disease of Scleroderma

Lung Diseases, Interstitial

Drug: Tadalafil;Drug: Placebo

Sanjay Gandhi Postgraduate Institute of Medical Sciences

NULL

Completed

18 Years

70 Years

Both

Phase 3

India

174

NCT01532869
(ClinicalTrials.gov)

March 2012

10/2/2012

A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

Sclerosis, Systemic

Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

United States;Canada;France;Germany;United Kingdom

175

EUCTR2010-022969-95-NL
(EUCTR)

27/02/2012

12/12/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

EUCTR2010-022969-95-PT
(EUCTR)

03/02/2012

12/12/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand

177

EUCTR2011-001460-22-GB
(EUCTR)

19/01/2012

17/10/2011

A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.

A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A

Systemic Sclerosis (SSc)
MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2;Phase 3

France;United States;Canada;Germany;United Kingdom

178

EUCTR2010-022969-95-BE
(EUCTR)

16/01/2012

29/11/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Phase 3

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

179

EUCTR2010-022710-77-FI
(EUCTR)

10/01/2012

07/12/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

180

EUCTR2010-022969-95-GB
(EUCTR)

21/12/2011

27/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Phase 3

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

EUCTR2010-022969-95-IE
(EUCTR)

07/12/2011

31/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

182

NCT01474109
(ClinicalTrials.gov)

December 2011

31/10/2011

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis

Systemic Sclerosis;Ulcers

Drug: macitentan 3mg;Drug: macitentan 10mg;Drug: placebo

Actelion

NULL

Completed

18 Years

N/A

All

289

Phase 3

United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine

183

NCT01538719
(ClinicalTrials.gov)

December 2011

21/2/2012

IL1-TRAP, Rilonacept, in Systemic Sclerosis

Randomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker Trial

Scleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic Sclerosis

Drug: Rilonacept;Other: Placebo

Boston University

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

184

NCT01474122
(ClinicalTrials.gov)

December 2011

31/10/2011

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Digital Ulcers

Drug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: Placebo

Actelion

NULL

Terminated

18 Years

N/A

All

265

Phase 3

United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom

185

EUCTR2011-001460-22-DE
(EUCTR)

28/11/2011

20/10/2011

A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A

Systemic Sclerosis (SSc)
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2;Phase 3

France;United States;Canada;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

EUCTR2010-022710-77-BG
(EUCTR)

17/11/2011

26/08/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

187

EUCTR2010-022969-95-DE
(EUCTR)

09/08/2011

31/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

188

NCT01086540
(ClinicalTrials.gov)

June 24, 2011

11/3/2010

Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)

A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)

Systemic Sclerosis-Associated PAH

Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.

Completed

18 Years

75 Years

All

Phase 2

United States

189

EUCTR2010-022710-77-DE
(EUCTR)

16/06/2011

31/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

190

EUCTR2010-022969-95-ES
(EUCTR)

26/05/2011

18/11/2011

A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).

Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis.

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

NCT01257802
(ClinicalTrials.gov)

May 2011

9/12/2010

GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases

Lupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial Diffuse

Drug: depot leuprolide acetate 3.75 mg;Drug: Placebo

Joseph Mccune

National Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Terminated

18 Years

40 Years

Female

Phase 3

United States

192

NCT01347008
(ClinicalTrials.gov)

April 2011

2/5/2011

Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis

Effect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial

Scleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud Phenomenon

Drug: Sildenafil citrate;Drug: Placebo (Sugar pill)

Federal University of São Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Completed

18 Years

N/A

Female

Phase 3

Brazil

193

EUCTR2010-022710-77-DK
(EUCTR)

22/03/2011

03/02/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

194

EUCTR2010-024005-13-GB
(EUCTR)

11/03/2011

30/12/2010

A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.

Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino

Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: alpha-2C AR antagonist
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: Alpha-2C AR antagonist

Orion Corporation Orion Pharma

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

195

NCT01315899
(ClinicalTrials.gov)

March 2011

14/3/2011

Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon

Phase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Raynaud's Phenomenon

Drug: ORM-12471 30mg;Drug: ORM-12471;Drug: placebo

Orion Corporation, Orion Pharma

NULL

Terminated

18 Years

75 Years

Both

Phase 2

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

EUCTR2010-022710-77-HU
(EUCTR)

28/02/2011

01/02/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

197

NCT01295736
(ClinicalTrials.gov)

November 2010

11/2/2011

Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY

Evaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled Study

Systemic Scleroderma

Drug: Sildenafil;Drug: placebo

University Hospital, Lille

NULL

Completed

18 Years

N/A

Both

Phase 3

France

198

NCT00946699
(ClinicalTrials.gov)

March 2010

23/7/2009

A Study of the Safety and Tolerability of MEDI-551 in Scleroderma

A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma

Scleroderma

Biological: MEDI-551;Biological: Placebo;Other: Placebo

MedImmune LLC

NULL

Completed

18 Years

N/A

Both

Phase 1

United States;Canada;United Kingdom

199

NCT01117298
(ClinicalTrials.gov)

November 2009

3/5/2010

A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study

Raynaud's Phenomenon;Digital Ulcers;Scleroderma

Drug: Tadalafil;Drug: Placebo

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Institute of Postgraduate Medical Education and Research;Postgraduate Institute of Medical Education and Research;Army Research and Referral hospital

Completed

18 Years

65 Years

Both

Phase 3

India

200

NCT00883129
(ClinicalTrials.gov)

September 2009

16/4/2009

Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)

Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)

Scleroderma;Interstitial Lung Disease

Drug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: Placebo

Michael Roth

National Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La Roche

Completed

18 Years

N/A

All

142

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

EUCTR2007-002015-38-IT
(EUCTR)

05/06/2009

19/06/2009

Skin Fibrosis in patients with systemic sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma

Product Name: P144

ISDIN S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Germany;United Kingdom;Spain;Italy

202

NCT00775463
(ClinicalTrials.gov)

May 2009

17/10/2008

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

DISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter Study

Systemic Sclerosis;Scleroderma

Drug: treprostinil diethanolamine;Drug: placebo

United Therapeutics

NULL

Completed

18 Years

N/A

All

148

Phase 2

United States;Canada;United Kingdom

203

EUCTR2007-003621-24-AT
(EUCTR)

30/03/2009

23/04/2008

Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

204

EUCTR2008-005018-39-GB
(EUCTR)

05/03/2009

22/05/2009

DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1

Systemic Sclerosis, scleroderma digital ulcers
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma

Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C-SR
INN or Proposed INN: treprostinil diethanolamine

United Therapeutics Corporation

NULL

Not Recruiting

Female: yes
Male: yes

150

United Kingdom

205

EUCTR2007-003621-24-GB
(EUCTR)

02/12/2008

14/07/2008

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

NCT00769028
(ClinicalTrials.gov)

December 2008

7/10/2008

AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis

A Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis

Systemic Sclerosis

Drug: Hyperimmune caprine serum;Drug: Albumin

Daval International Limited

NULL

Active, not recruiting

18 Years

N/A

Both

Phase 2

United Kingdom

207

NCT00442611
(ClinicalTrials.gov)

November 2008

1/3/2007

A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic Sclerosis

Scleroderma, Diffuse;Scleroderma, Systemic

Drug: Abatacept;Drug: Placebo

Stanford University

Bristol-Myers Squibb

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

208

NCT00984932
(ClinicalTrials.gov)

September 2008

24/9/2009

Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension

The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial

Systemic Sclerosis

Drug: Rosuvastatin

Faculty of Medicine, University of Alexandria

NULL

Completed

N/A

Both

Phase 3

Egypt

209

EUCTR2007-003621-24-NL
(EUCTR)

23/07/2008

13/03/2008

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

210

EUCTR2007-003621-24-IT
(EUCTR)

15/07/2008

17/11/2008

Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil

MONDOGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

EUCTR2007-003621-24-BE
(EUCTR)

20/06/2008

08/01/2008

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom

212

EUCTR2007-003621-24-FR
(EUCTR)

29/05/2008

27/12/2007

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

213

EUCTR2007-003122-24-GB
(EUCTR)

09/04/2008

15/02/2008

A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis

Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis
MedDRA version: 9.1;Classification code 10036814;Term: Progressive systemic sclerosis
MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma
MedDRA version: 9.1;Classification code 10012941;Term: Diffuse scleroderma
MedDRA version: 9.1;Classification code 10018124;Term: Generalized scleroderma
MedDRA version: 9.1;Classification code 10042954;Term: Systemic sclerosis pulmonary

Daval International Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

214

NCT01545427
(ClinicalTrials.gov)

April 2008

1/3/2012

Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma

A Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma

Scleroderma

Drug: Imatinib mesylate;Other: Placebo

Lawson Health Research Institute

Novartis Pharmaceuticals

Terminated

18 Years

N/A

Both

Phase 2

Canada

215

EUCTR2007-003621-24-DE
(EUCTR)

20/03/2008

13/02/2009

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

EUCTR2007-002015-38-DE
(EUCTR)

20/12/2007

03/08/2007

PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS.

SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma

Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM

ISDIN

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Germany;Italy;United Kingdom

217

EUCTR2007-002015-38-GB
(EUCTR)

19/12/2007

31/07/2007

SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma

ISDIN

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Germany;Italy;United Kingdom

218

NCT00577304
(ClinicalTrials.gov)

December 2007

18/12/2007

A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon

Raynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Other Autoimmune Disease

Drug: Nitroglycerin;Drug: Topical AmphiMatrix

MediQuest Therapeutics

NULL

Active, not recruiting

15 Years

70 Years

Both

200

Phase 3

United States

219

NCT00581997
(ClinicalTrials.gov)

December 2007

21/12/2007

QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis

Pulmonary Fibrosis Secondary to Systemic Sclerosis

Drug: QAX576;Drug: Placebo

Novartis Pharmaceuticals

NULL

Terminated

18 Years

65 Years

Both

Phase 2

United States

220

NCT00479934
(ClinicalTrials.gov)

December 2007

29/5/2007

Efficacy and Safety of Imatinib in Scleroderma

Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement.

Scleroderma, Localized;Scleroderma, Systemic

Drug: imatinib mesylate

University Hospital, Bordeaux

Ministry of Health, France;Novartis

Completed

18 Years

N/A

Both

Phase 2

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

EUCTR2007-002015-38-HU
(EUCTR)

04/09/2007

09/07/2007

Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.

SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma

Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM

ISDIN

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Germany;United Kingdom;Spain;Italy

222

NCT00574613
(ClinicalTrials.gov)

September 2007

13/12/2007

Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis

Phase II, Multicenter, Randomized, Double-blind, Intraindividually Placebo Controlled Clinical Trial, to Evaluate Efficacy and Safety of p144 Topical Administration for Skin Fibrosis in Patients With Systemic Sclerosis

Skin Fibrosis

Drug: P144;Drug: placebo

ISDIN

Digna Biotech S.L.

Completed

18 Years

65 Years

Both

Phase 2

Germany;Hungary;Italy;Poland;Spain;United Kingdom

223

EUCTR2007-002015-38-ES
(EUCTR)

23/08/2007

02/07/2007

ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS

FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma

Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM

ISDIN

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Germany;United Kingdom;Spain;Italy

224

NCT00419419
(ClinicalTrials.gov)

December 2006

4/1/2007

Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon

Phase III In-Life Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon

Raynaud's Disease;Scleroderma;Autoimmune Diseases

Drug: Topical AmphiMatrix with nitroglycerin (MQX-503)

MediQuest Therapeutics

NULL

Completed

18 Years

70 Years

Both

Phase 3

United States;Sweden;United Kingdom

225

EUCTR2005-004979-37-GB
(EUCTR)

27/11/2006

18/09/2006

Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2

Moderate to severe primary Raynaud’s, OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma

MediQuest Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

EUCTR2005-004979-37-SE
(EUCTR)

27/10/2006

08/09/2006

Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2

Moderate to severe primary Raynaud’s,OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma

Product Name: MQX-503
Product Code: MQX-503
INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP
Other descriptive name: Nitroglycerine gel

MediQuest Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United Kingdom;Sweden

227

NCT00377455
(ClinicalTrials.gov)

September 2006

14/9/2006

Placebo Controlled Trial of Bosentan in Scleroderma Patients

Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension

Systemic Scleroderma;Pulmonary Hypertension

Drug: Bosentan;Drug: Placebo

Georgetown University

Actelion

Terminated

18 Years

N/A

All

Phase 2

United States

228

NCT00348296
(ClinicalTrials.gov)

July 2006

3/7/2006

Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis

Scleroderma, Systemic

Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH)

Benesis Corporation

NULL

Completed

16 Years

N/A

Both

Phase 3

Japan

229

EUCTR2006-000905-41-AT
(EUCTR)

07/06/2006

08/05/2006

Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud

Raynaud syndrome with / without systemic sclerosis

Trade Name: Ilomedin
Product Name: Ilomedin
Product Code: 1-22460

ao. Univ. Prof. Dr. Elisabeth Aberer

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Austria

230

NCT00740285
(ClinicalTrials.gov)

April 2004

19/8/2008

Effectiveness and Safety of Lidocaine for Scleroderma

Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial

Scleroderma

Drug: Lidocaine 2% without vessel constrictor;Other: Placebo - physiological solution 0,9%

Federal University of São Paulo

NULL

Completed

18 Years

60 Years

Both

Phase 2;Phase 3

Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

NCT00077584
(ClinicalTrials.gov)

October 2003

10/2/2004

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis

Digital Ulcers;Systemic Sclerosis

Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo

Actelion

NULL

Completed

18 Years

N/A

Both

188

Phase 3

United States;Canada

232

NCT02800993
(ClinicalTrials.gov)

October 2003

13/6/2016

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis

Systemic Sclerosis;Digital Ulcers

Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo

Actelion

NULL

Completed

18 Years

N/A

Both

188

Phase 3

United States;Canada

233

NCT00070590
(ClinicalTrials.gov)

July 2003

6/10/2003

Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

Pulmonary Fibrosis;Scleroderma, Systemic

Drug: Bosentan

Actelion

NULL

Completed

18 Years

N/A

Both

132

Phase 2;Phase 3

United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom

234

NCT00043706
(ClinicalTrials.gov)

May 2002

12/8/2002

Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis

A Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis

Systemic Sclerosis;Scleroderma

Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody

Genzyme, a Sanofi Company

Cambridge Antibody Technology

Completed

18 Years

75 Years

Both

Phase 1;Phase 2

United States

235

NCT00707187
(ClinicalTrials.gov)

July 2001

25/6/2008

Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis

Systemic Sclerosis

Drug: Cialis

University of Medicine and Dentistry of New Jersey

NULL

Completed

18 Years

N/A

Female

120

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

NCT00418132
(ClinicalTrials.gov)

August 2000

3/1/2007

Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis

T Cell Immunity in Collagen Biosynthesis of Scleroderma

Scleroderma, Systemic

Drug: Thalidomide;Drug: Placebo thalidomide

New York University School of Medicine

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Terminated

18 Years

65 Years

Both

Phase 1

United States

237

NCT00005675
(ClinicalTrials.gov)

April 2000

26/5/2000

Oral Type I Collagen for Relieving Scleroderma

Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma

Scleroderma;Connective Tissue Diseases

Drug: Oral bovine type I collagen;Drug: Placebo

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Wayne State University;University of California, Los Angeles;UTHSC;MUSC;Beth Israel Medical Center;University of Alabama at Birmingham;Johns Hopkins University;Georgetown University;Baltimore VA Medical Center;Northwestern University

Completed

18 Years

N/A

Both

168

Phase 2

United States

238

NCT00004563
(ClinicalTrials.gov)

August 1999

9/2/2000

Scleroderma Lung Disease

Cyclophosphamide Versus Placebo in Scleroderma Lung Study

Lung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, Systemic

Drug: Cyclophosphamide;Drug: Placebo

The University of Texas Health Science Center, Houston

National Heart, Lung, and Blood Institute (NHLBI)

Completed

18 Years

N/A

All

158

Phase 3

NULL

239

NCT00704665
(ClinicalTrials.gov)

December 1998

23/6/2008

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma

Systemic Sclerosis

Drug: Relaxin

University of Medicine and Dentistry of New Jersey

University of California, Los Angeles;Boston University;University of Chicago;University of Connecticut Health Center;Johns Hopkins University;University of Pittsburgh;Medical University of South Carolina;Stanford University;Georgetown University;University of California, San Diego;Wayne State University;University of Colorado, Denver;Medical College of Wisconsin

Completed

18 Years

70 Years

Both

231

Phase 3

NULL

240

NCT00004786
(ClinicalTrials.gov)

December 1995

24/2/2000

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Systemic Sclerosis;Raynaud Disease

Drug: iloprost

National Center for Research Resources (NCRR)

University of Pittsburgh

Completed

18 Years

N/A

Both

200

Phase 3

NULL