51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | NCT04432545 (ClinicalTrials.gov) | September 1, 2022 | 10/6/2020 | Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement | Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to Treatment | Systemic Sclerosis Pulmonary;Pulmonary Hypertension;Pulmonary Fibrosis | Biological: Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jelly | Universidad de la Sabana | Fundación Neumologica Colombiana;Stem Medicina Regenerativa;CryoHoldco LATAM | Available | 18 Years | 65 Years | All | Colombia | ||
| 2 | NCT03800017 (ClinicalTrials.gov) | September 1, 2022 | 21/11/2018 | Skeletal Muscle Function in Interstitial Lung Disease | Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease | Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial Pneumonia | Biological: Hyperoxia | University of British Columbia | NULL | Not yet recruiting | 40 Years | 80 Years | All | 40 | N/A | NULL |
| 3 | NCT04356287 (ClinicalTrials.gov) | April 2022 | 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 |
| 4 | NCT05214014 (ClinicalTrials.gov) | March 1, 2022 | 29/11/2021 | Treatment of Systemic Sclerosis With Autologous Regulatory ?-cells | Treatment of Patients With Systemic Sclerosis With Autologous Regulatory ?-cells | Systemic Sclerosis | Biological: Autologous Regulatory ?-cells;Other: Standard treatment according to the clinical protocols | Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Belarusian State Medical University | Not yet recruiting | 18 Years | 80 Years | All | 30 | Phase 1/Phase 2 | NULL |
| 5 | NCT05198557 (ClinicalTrials.gov) | March 2022 | 6/1/2022 | A Study of MT-0551 in Patients With Systemic Sclerosis | Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study) | Systemic Sclerosis | Drug: Inebilizumab;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Not yet recruiting | 20 Years | 80 Years | All | 80 | Phase 3 | Japan |
| 6 | NCT04986605 (ClinicalTrials.gov) | March 2022 | 1/6/2021 | Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis | The Effectiveness of ECP in Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis | Other: Extracorporeal Photopheresis (ECP) with Methoxsalen | Lawson Health Research Institute | Mallinckrodt | Not yet recruiting | 18 Years | N/A | All | 15 | Phase 2 | Canada |
| 7 | NCT05236491 (ClinicalTrials.gov) | March 2022 | 10/2/2022 | COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases | COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases | Rheumatoid Arthritis;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Systemic Vasculitis;Systemic Sclerosis;Scleroderma;Undifferentiated Connective Tissue Diseases;Overlap Connective Tissue Disease;Immunosuppression | Biological: COVID-19 vaccine | Paul R Fortin | Canadian Institutes of Health Research (CIHR) | Not yet recruiting | 18 Years | N/A | All | 287 | Phase 2/Phase 3 | NULL |
| 8 | NCT04380831 (ClinicalTrials.gov) | February 24, 2022 | 30/4/2020 | TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body Irradiation | City of Hope Medical Center | National Cancer Institute (NCI) | Recruiting | 18 Years | 65 Years | All | 15 | Early Phase 1 | United States |
| 9 | NCT05270668 (ClinicalTrials.gov) | February 22, 2022 | 27/2/2022 | Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | Diffuse Cutaneous Systemic Sclerosis;Interstitial Lung Disease | Drug: PRA023 IV;Device: Companion diagnostic ( CDx);Drug: Placebo | Prometheus Biosciences, Inc. | PPD | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States |
| 10 | NCT05214794 (ClinicalTrials.gov) | February 14, 2022 | 17/1/2022 | An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis | An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis | Systemic Sclerosis | Drug: nemolizumab | Maruho Co., Ltd. | NULL | Not yet recruiting | 20 Years | 70 Years | All | 8 | Phase 2 | Japan |
| 11 | NCT05016804 (ClinicalTrials.gov) | February 2022 | 17/8/2021 | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis | Systemic Sclerosis | Biological: AlloRx | The Foundation for Orthopaedics and Regenerative Medicine | NULL | Recruiting | N/A | N/A | All | 20 | Phase 1 | Antigua and Barbuda |
| 12 | NCT04789850 (ClinicalTrials.gov) | January 2022 | 10/2/2021 | Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis | Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial | Systemic Sclerosis | Drug: Itacitinib;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | N/A | All | 74 | Phase 2 | France |
| 13 | NCT05029336 (ClinicalTrials.gov) | December 2021 | 24/8/2021 | Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases | Systemic Lupus Erythematosus;Systemic Sclerosis | Biological: Depletion of CD3/CD19 in an autologous stem cell transplant | Stephan Grupp MD PhD | NULL | Recruiting | 8 Years | 25 Years | All | 20 | Phase 2 | United States |
| 14 | NCT05098145 (ClinicalTrials.gov) | November 24, 2021 | 20/10/2021 | A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis | A Single-arm, Multi-center, Open-label Proof of Concept Safety and Efficacy Study of FCR001 Cell-based Therapy in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis at Risk for Organ Failure | Diffuse Cutaneous Systemic Sclerosis | Biological: FCR001 | Talaris Therapeutics Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 18 | Phase 1/Phase 2 | United States |
| 15 | NCT04478994 (ClinicalTrials.gov) | November 17, 2021 | 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 |
| 16 | NCT04915950 (ClinicalTrials.gov) | November 3, 2021 | 1/6/2021 | A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis | Raynaud's Phenomenon Secondary to Systemic Sclerosis | Drug: Temanogrel;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 48 | Phase 2 | United States;United Kingdom |
| 17 | NCT04927390 (ClinicalTrials.gov) | November 1, 2021 | 19/5/2021 | Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot) | A Randomised Prospective Open Label Pilot Trial Comparing Mycophenolate Mofetil (MMF) With no Immunosuppression in Adults With Limited Cutaneous Systemic Sclerosis | Systemic Sclerosis;Limited Cutaneous Systemic Sclerosis | Drug: Mycophenolate Mofetil 500mg | University College, London | Versus Arthritis | Not yet recruiting | 18 Years | N/A | All | 120 | Phase 2 | United Kingdom |
| 18 | NCT05085444 (ClinicalTrials.gov) | October 8, 2021 | 11/10/2021 | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma | Scleroderma;Autoimmune Diseases | Biological: Assigned Interventions CD19/BCMA CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 9 | Early Phase 1 | China |
| 19 | NCT04797286 (ClinicalTrials.gov) | September 20, 2021 | 11/3/2021 | Sildenafil for Early Pulmonary Vascular Disease in Scleroderma | Sildenafil for Early Pulmonary Vascular Disease in Scleroderma | Scleroderma;Mildly Elevated Pulmonary Pressures | Drug: Sildenafil;Other: Placebo | Johns Hopkins University | Louisiana State University Health Sciences Center in New Orleans | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 20 | NCT04948554 (ClinicalTrials.gov) | September 16, 2021 | 4/6/2021 | Study of ACE-1334 to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease | A Phase 1b/2 Open-Label, Multiple-Ascending Dose Study Followed by a Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease | Systemic Sclerosis With and Without Interstitial Lung Disease | Drug: ACE-1334;Drug: Placebo | Acceleron Pharma Inc. | NULL | Recruiting | 18 Years | N/A | All | 210 | Phase 1/Phase 2 | United States |
| 21 | NCT05007340 (ClinicalTrials.gov) | August 24, 2021 | 29/7/2021 | ILD-SARDs Registry and Biorepository | Interstitial Lung Disease in Systemic Autoimmune Rheumatic Diseases (ILD-SARDs) Registry and Biorepository | Interstitial Lung Disease;Systemic Autoimmune Disease;Rheumatic Diseases;Rheumatic Arthritis;Systemic Sclerosis;Autoimmune Myositis;Systemic Lupus Erythematosus;Usual Interstitial Pneumonia;Nonspecific Interstitial Pneumonia | Other: Blood draws;Other: Other biological samples to biobank (skin, lung and muscle biopsies; bronchoalveolar lavage (BAL fluid);Other: Clinical data collection;Other: Genetic data/DNA/RNA | McGill University Health Centre/Research Institute of the McGill University Health Centre | McGill University | Recruiting | 18 Years | N/A | All | 252 | Canada | |
| 22 | NCT05000216 (ClinicalTrials.gov) | August 13, 2021 | 6/8/2021 | COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders | Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01) | Rheumatoid Arthritis;Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis;Systemic Sclerosis (SSc) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: IS (MMF or MPA);Drug: IS (MTX);Biological: IS (B cell depletion therapy) | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Recruiting | 18 Years | N/A | All | 600 | Phase 2 | United States |
| 23 | NCT04966416 (ClinicalTrials.gov) | August 1, 2021 | 14/7/2021 | Calcinosis Reduction by Pyrophosphate in SSC | The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis | Systemic Sclerosis;Scleroderma | Dietary Supplement: Pyrophosphate;Dietary Supplement: Placebo | Szeged University | Research Centre for Natural Sciences;University of Debrecen Dept. of Rheumatology | Not yet recruiting | 18 Years | 70 Years | All | 60 | N/A | NULL |
| 24 | NCT04647890 (ClinicalTrials.gov) | July 19, 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 | Recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Australia |
| 25 | NCT04627857 (ClinicalTrials.gov) | July 1, 2021 | 6/11/2020 | Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis | Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis | Scleroderma Systemic | Device: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss) | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | France |
| 26 | NCT04837131 (ClinicalTrials.gov) | April 28, 2021 | 5/4/2021 | A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients | A Phase 2 Open-Label Pilot Study of the Safety and Tolerability of Ixazomib Administered Orally to Patients With Scleroderma-Related Interstitial Lung Disease | Systemic Sclerosis;Scleroderma;Diffuse Systemic Sclerosis;Diffuse Scleroderma;Diffuse Cutaneous Systemic Sclerosis;Diffuse Cutaneous Scleroderma;Progressive Systemic Sclerosis;Progressive Scleroderma;Scleroderma, Systemic;Scleroderma, Diffuse;Progressive;Systemic Sclerosis, Diffuse;Systemic; Sclerosis, Progressive;Scleroderma of Lung;Scleroderma With Pulmonary Involvement;Systemic Sclerosis Pulmonary;Systemic Sclerosis With Lung Involvement;Interstitial Lung Disease;Pulmonary Fibrosis Interstitial | Drug: Ixazomib | W. Leroy Griffing | NULL | Recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 27 | NCT04826419 (ClinicalTrials.gov) | April 1, 2021 | 29/3/2021 | Effect of Ozone Therapy for the Treatment of Digital Ulcer in Patients With SSc | Non-invazive Ozone Therapy and Digital Ulcer in Patients With SSc | Systemic Sclerosis | Other: ozone therapy | Pamukkale University | NULL | Completed | 18 Years | 75 Years | All | 25 | N/A | Turkey |
| 28 | NCT04781543 (ClinicalTrials.gov) | April 1, 2021 | 1/3/2021 | A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis;Sclerosis, Systemic | Drug: HZN-825 BID;Drug: Placebo;Drug: HZN-825 QD | Horizon Therapeutics Ireland DAC | NULL | Recruiting | 18 Years | 75 Years | All | 300 | Phase 2 | United States;Argentina;France;Greece;Korea, Republic of;Portugal |
| 29 | NCT04746313 (ClinicalTrials.gov) | March 1, 2021 | 8/2/2021 | Prevalence of Hyperprolactinemia in Systemic Scleroderma | Assessment of the Prevalence of Hyperprolactinemia in Systemic Scleroderma | Sclerosis, Systemic;Scleroderma;Hyperprolactinemia | Biological: blood test | University Hospital, Lille | Association pour la Formation et la Recherche en Médecine Interne (AFORMI) | Recruiting | 18 Years | N/A | All | 200 | France | |
| 30 | NCT04683029 (ClinicalTrials.gov) | February 24, 2021 | 22/12/2020 | A Study of Guselkumab in Participants With Systemic Sclerosis | A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic Sclerosis | Scleroderma, Systemic | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Placebo | Janssen Pharmaceutical K.K. | NULL | Recruiting | 18 Years | 75 Years | All | 56 | Phase 2 | Japan |
| 31 | NCT04440592 (ClinicalTrials.gov) | February 5, 2021 | 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 | N/A | All | 72 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 32 | 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 |
| 33 | NCT04744207 (ClinicalTrials.gov) | December 29, 2020 | 28/1/2021 | A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis | A Phase II, Randomized, Multi-center, 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 Subjects With Systemic Sclerosis (SSc) | Systemic Sclerosis | Drug: GS-248;Drug: Placebo | Gesynta Pharma AB | Ergomed | Recruiting | 18 Years | 75 Years | All | 80 | Phase 2 | Belgium;Netherlands;Poland;United Kingdom |
| 34 | NCT04680975 (ClinicalTrials.gov) | December 24, 2020 | 11/12/2020 | Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | Diffuse Cutaneous Systemic Sclerosis | Drug: Belumosudil | Kadmon Corporation, LLC | NULL | Active, not recruiting | 18 Years | N/A | All | 15 | Phase 2 | United States |
| 35 | NCT04303208 (ClinicalTrials.gov) | December 2020 | 3/3/2020 | Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic Sclerosis | Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic Sclerosis | Systemic Sclerosis | Procedure: 2 ml of whole blood sample will be collected on EDTA tube | Assiut University | NULL | Not yet recruiting | 18 Years | N/A | All | 80 | N/A | NULL |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 | NULL | Recruiting | 18 Years | 74 Years | All | 36 | Phase 2 | United States;Australia;New Zealand |
| 39 | NCT04265144 (ClinicalTrials.gov) | June 8, 2020 | 5/2/2020 | Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre | Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases | Scleroderma;Systemic Sclerosis | Biological: Blood samples;Other: Biopsy;Other: Bronchoalveolar samples | University Hospital, Bordeaux | NULL | Recruiting | 18 Years | N/A | All | 500 | N/A | France |
| 40 | NCT04244916 (ClinicalTrials.gov) | May 25, 2020 | 6/1/2020 | MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis | Prospective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic Sclerosis | Systemic Sclerosis | Biological: AUC of MPA measure | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 50 | France | |
| 41 | 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 |
| 42 | NCT04523506 (ClinicalTrials.gov) | May 8, 2020 | 19/7/2020 | The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma | The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma | Scleroderma | Biological: Botulinum toxin(Botox) | University of Texas Southwestern Medical Center | NULL | Completed | 18 Years | 65 Years | All | 17 | Early Phase 1 | United States |
| 43 | NCT04325217 (ClinicalTrials.gov) | April 15, 2020 | 26/3/2020 | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 44 | NCT03582800 (ClinicalTrials.gov) | January 6, 2020 | 13/6/2018 | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | Systemic Sclerosis;Dermatomyositis;iPPSD2 | Drug: STS | University Hospital, Limoges | NULL | Recruiting | 6 Months | N/A | All | 40 | Phase 2 | France |
| 45 | 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 |
| 46 | NCT04656704 (ClinicalTrials.gov) | January 1, 2020 | 30/11/2020 | Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease | Investigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease | Microstomia;Scleroderma;CREST Syndrome;Scleromyxedema;Morphea | Drug: hyaluronidase injected intradermally | Brigham and Women's Hospital | NULL | Withdrawn | 18 Years | N/A | All | 0 | Early Phase 1 | NULL |
| 47 | 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 |
| 48 | NCT03740724 (ClinicalTrials.gov) | December 18, 2019 | 6/11/2018 | A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) | A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) | Morphea;Scleroderma, Localized;Scleroderma | Genetic: FCX-013;Drug: veledimex | Castle Creek Biosciences, LLC. | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 49 | NCT04095351 (ClinicalTrials.gov) | December 9, 2019 | 13/9/2019 | Connective Tissue Diseases and Lung Manifestations | Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris) | Connective Tissue Diseases;Interstitial Lung Disease;Systemic Sclerosis | Diagnostic Test: Pulmonary function test;Diagnostic Test: Imaging;Biological: Blood sampling | Medical University Innsbruck | Boehringer Ingelheim | Recruiting | 18 Years | 80 Years | All | 120 | Austria | |
| 50 | 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 | Completed | 18 Years | N/A | All | 198 | Phase 3 | United States |
| 51 | NCT04137224 (ClinicalTrials.gov) | September 19, 2019 | 21/10/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc) | Diffuse Cutaneous Systemic Sclerosis | Biological: IgPro20;Biological: IgPro10 | CSL Behring | NULL | Active, not recruiting | 18 Years | N/A | All | 27 | Phase 2 | Australia;Germany;Italy;Poland;United Kingdom;France |
| 52 | 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 |
| 53 | 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 | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | Greece |
| 54 | NCT03976648 (ClinicalTrials.gov) | July 18, 2019 | 4/6/2019 | A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis | A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis | Systemic Sclerosis | Drug: GLPG1690 | Galapagos NV | NULL | Terminated | 18 Years | N/A | All | 31 | Phase 2 | United States;Belgium;Italy;Spain;United Kingdom |
| 55 | 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 | Active, not recruiting | 18 Years | 100 Years | All | 60 | Phase 2 | United States |
| 56 | 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 |
| 57 | 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 |
| 58 | NCT03198689 (ClinicalTrials.gov) | May 7, 2019 | 14/6/2017 | Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis | A Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma) | Diffuse Cutaneous Systemic Sclerosis | Drug: Brentuximab Vedotin | Lawson Health Research Institute | Seagen Inc. | Recruiting | 18 Years | N/A | All | 11 | Phase 2 | Canada |
| 59 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 312 | Phase 1 | United States;Canada |
| 60 | 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 |
| 61 | 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 | Systemic Sclerosis | Drug: GLPG1690;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 33 | Phase 2 | United States;Belgium;Germany;Italy;Spain;United Kingdom |
| 62 | NCT03831438 (ClinicalTrials.gov) | January 1, 2019 | 31/1/2019 | Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis | A Phase 1 Open-Label Study to Determine the Safety and Tolerability of AVID200: A Transforming Growth Factor ß (TGFß) Inhibitor, in Patients With Diffuse Cutaneous Systemic Sclerosis | Scleroderma, Diffuse | Drug: AVID200 | Formation Biologics | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 63 | 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 |
| 64 | EUCTR2018-001719-65-NL (EUCTR) | 10/12/2018 | 09/07/2018 | CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study | CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study | Systemic sclerosis (SSc) is a rare progressive autoimmune disease hallmarked by severe vasculopathy. Patients are prone to enhanced calcification of skin and the vasculature. Active calcifications may not only occur in the skin of patients with clinically overt calcinosis cutis, but also in SSc patients without. Since calcification is strongly associated with local inflammation, it may very well occur in internal organs and serve as an early proxy for long-term SSc-related complications.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Sodium fluoride 18F Product Code: EMA/CHMP/212874/2015 | University Medial Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 65 | NCT03742466 (ClinicalTrials.gov) | November 10, 2018 | 10/11/2018 | Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients | Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial | Carpal Tunnel Syndrome;Chronic Pain;Scleroderma | Drug: Ozone;Drug: methylprednisolone acetate | Assiut University | NULL | Completed | 20 Years | 60 Years | All | 50 | N/A | Egypt |
| 66 | 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 |
| 67 | 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 |
| 68 | NCT03575156 (ClinicalTrials.gov) | September 20, 2018 | 7/6/2018 | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Systemic Lupus Erythematosus;Systemic Scleroderma | Biological: blood sample;Biological: urine sample | University Hospital, Bordeaux | NULL | Active, not recruiting | 18 Years | N/A | All | 208 | N/A | France |
| 69 | NCT03678987 (ClinicalTrials.gov) | September 13, 2018 | 13/9/2018 | Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis | Mycophenolate Mofetil in Systemic Sclerosis: A Phase 1 Pharmacokinetic Study of Orally Ingested Mycophenolate Mofetil Tablets in Patients Suffering From Systemic Sclerosis | Systemic Sclerosis;Gastrointestinal Complication | Diagnostic Test: P-MPA concentration;Drug: mycophenolic acid | Region Skane | NULL | Completed | 18 Years | N/A | All | 35 | Phase 1 | Sweden |
| 70 | NCT03726398 (ClinicalTrials.gov) | September 1, 2018 | 21/10/2018 | CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH | CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated Interstitial Lung DiseasE and Pulmonary Hypertension (PH): The CRuSADE PH Study | Interstitial Lung Disease;Scleroderma;Pulmonary Hypertension | Drug: Opsumit 10 Mg Tablet | Franz Rischard, DO | National Jewish Health;University of Pittsburgh | Recruiting | 18 Years | N/A | All | 26 | Phase 2/Phase 3 | United States |
| 71 | NCT03629002 (ClinicalTrials.gov) | September 2018 | 7/8/2018 | BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA | BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND | Systemic Scleroderma | Biological: Study of the gene expression profile | Assistance Publique Hopitaux De Marseille | NULL | Unknown status | 18 Years | N/A | All | 30 | France | |
| 72 | 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 | Completed | 18 Years | 65 Years | All | 70 | Phase 4 | Brazil |
| 73 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation | Paul Szabolcs | NULL | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States |
| 74 | 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 |
| 75 | NCT03644225 (ClinicalTrials.gov) | June 11, 2018 | 4/5/2018 | Suction Based Characterization of Healthy and Diseased Skin | Mechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin Deformability | Systemic Sclerosis | Device: Measurment with Aspirational Medical Device;Device: Measurment with Cutometer MPA 580 | Oliver Distler | Swiss Federal Institute of Technology | Completed | 18 Years | N/A | All | 67 | N/A | Switzerland |
| 76 | NCT03365869 (ClinicalTrials.gov) | June 1, 2018 | 4/12/2017 | A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis | A Phase ? Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Sirolimus | Peking University People's Hospital | NULL | Not yet recruiting | 18 Years | 80 Years | All | 72 | Phase 2 | NULL |
| 77 | NCT03593902 (ClinicalTrials.gov) | May 17, 2018 | 28/6/2018 | Cardiac Safe Transplants for Systemic Sclerosis | Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction | Systemic Sclerosis;Scleroderma | Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 2/Phase 3 | United States |
| 78 | NCT03607071 (ClinicalTrials.gov) | May 15, 2018 | 20/7/2018 | Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma | Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study | Myocardial Inflammation | Drug: Prednisolone and taper | Khon Kaen University | NULL | Completed | 18 Years | N/A | All | 20 | Phase 2 | Thailand |
| 79 | NCT03508375 (ClinicalTrials.gov) | May 15, 2018 | 16/4/2018 | Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis | Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis | Systemic Scleroderma | Biological: blood samples | Assistance Publique Hopitaux De Marseille | NULL | Recruiting | 18 Years | N/A | All | 75 | N/A | France |
| 80 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 81 | 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 | Completed | 18 Years | N/A | All | 35 | Phase 2 | United Kingdom |
| 82 | 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 | Terminated | 18 Years | N/A | All | 365 | Phase 3 | United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom |
| 83 | 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 |
| 84 | 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 | 51 | Phase 2 | United States |
| 85 | NCT03313180 (ClinicalTrials.gov) | November 27, 2017 | 13/10/2017 | A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis | An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD) | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Active, not recruiting | 18 Years | N/A | All | 444 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;India;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom;Ireland |
| 86 | NCT04368403 (ClinicalTrials.gov) | October 6, 2017 | 13/4/2020 | A Study of KHK4827 in Patients With Systemic Sclerosis | A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis | Systemic Sclerosis | Drug: KHK4827 | Kyowa Kirin Co., Ltd. | NULL | Active, not recruiting | 18 Years | 70 Years | All | 8 | Phase 1 | Japan |
| 87 | 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 |
| 88 | 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.;PPD;Rho Federal Systems Division, Inc. | Recruiting | 18 Years | 70 Years | All | 24 | Phase 1/Phase 2 | United States;Canada |
| 89 | 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] | 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland | ||
| 90 | 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 |
| 91 | 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 |
| 92 | NCT04822038 (ClinicalTrials.gov) | June 1, 2017 | 12/2/2021 | Immunomodulating Effects of Supplementation With 25-OH Vitamin D | Immunomodulating Effects of Supplementation With 25 oh Vitamin D in Adults With Scleroderma and Hypovitaminosis D | Vitamin D Deficiency;Scleroderma, Systemic | Dietary Supplement: Vitamin D3;Other: Dietary recommendations | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | N/A | All | 49 | N/A | Mexico |
| 93 | NCT03155464 (ClinicalTrials.gov) | June 1, 2017 | 24/4/2017 | Intraoperative ICG for Systemic Sclerosis | A Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic Scerlosis | Systemic Sclerosis | Procedure: Order of two elements of surgical procedure;Drug: Indocyanine Green | Duke University | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | NULL |
| 94 | 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] | 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland | ||
| 95 | 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 |
| 96 | 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 |
| 97 | 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 |
| 98 | NCT02921971 (ClinicalTrials.gov) | December 21, 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;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 |
| 99 | NCT03007004 (ClinicalTrials.gov) | December 12, 2016 | 28/12/2016 | Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis | Trial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis | Systemic Sclerosis Patients With Digital Ulcers | Drug: Botulinum toxin type B (2500 units / vial);Drug: Physiological saline | Gunma University | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | Japan |
| 100 | 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 |
| 101 | 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 |
| 102 | NCT03388255 (ClinicalTrials.gov) | November 8, 2016 | 21/12/2017 | Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma Diseases | A Phase IV, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in Patients With Fibrotic and Atrophic Cutaneous Lesions in Scleroderma Diseases | Scleroderma Disease | Drug: Polydeoxyribonucleotides | Mastelli S.r.l | Sintesi Research Srl | Terminated | 18 Years | N/A | All | 25 | Phase 4 | Italy |
| 103 | NCT02975960 (ClinicalTrials.gov) | October 25, 2016 | 9/11/2016 | ADMSCs for the Treatment of Systemic Sclerosis | Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Biological: injection of autologous stromal vascular fraction | The Catholic University of Korea | Seoul St. Mary's Hospital | Completed | 18 Years | N/A | All | 7 | N/A | Korea, Republic of |
| 104 | NCT02663895 (ClinicalTrials.gov) | October 2016 | 19/1/2016 | Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | Systemic Sclerosis;Calcinosis | Drug: Oral treprostinil | Stanford University | United Therapeutics | Completed | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 105 | 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 |
| 106 | NCT02798055 (ClinicalTrials.gov) | September 30, 2016 | 3/6/2016 | Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis | A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment. | Systematic Sclerosis;Digital Ulcer;Scleroderma | Drug: Bosentan group | Elpen Pharmaceutical Co. Inc. | NULL | Completed | 18 Years | 80 Years | All | 148 | Greece | |
| 107 | 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 |
| 108 | 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 | ||
| 109 | 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 | ||
| 110 | 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 | ||
| 111 | 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 | ||
| 112 | NCT02801305 (ClinicalTrials.gov) | June 2016 | 9/6/2016 | Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers | Assessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers. | Digital Ulcer of Scleroderma | Drug: Diltiazem Gel 2%;Drug: Nitroglycerin Ointment 2%;Drug: Vaseline | Mohammad Ali Nazarinia | Shiraz University of Medical Sciences | Completed | 20 Years | 70 Years | All | 90 | Phase 2 | Iran, Islamic Republic of |
| 113 | NCT02733978 (ClinicalTrials.gov) | June 2016 | 25/3/2016 | Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis | Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis | Ulcer;Scleroderma | Device: the ozone generator device (Human Pro medic, German) | Assiut University | NULL | Completed | N/A | N/A | All | 50 | N/A | NULL |
| 114 | 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 |
| 115 | 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 |
| 116 | NCT02680717 (ClinicalTrials.gov) | March 2016 | 9/2/2016 | Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea | Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea | Scleroderma | Drug: Clobetasol;Drug: Calcipotriene;Drug: Tacrolimus | Medical College of Wisconsin | Mayo Clinic;Seattle Children's Hospital;University of Toronto | Withdrawn | 2 Years | 18 Years | All | 0 | Phase 1 | NULL |
| 117 | NCT02426229 (ClinicalTrials.gov) | February 2016 | 4/3/2015 | Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma | Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma | Scleroderma;Interstitial Lung Disease | Drug: dabigatran etexilate | Medical University of South Carolina | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 18 Years | 70 Years | All | 15 | Phase 1 | United States |
| 118 | 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;Diagnostic Test: Vasculopathy assessment;Drug: Placebo | VA Office of Research and Development | NULL | Completed | 18 Years | 95 Years | All | 12 | Phase 1/Phase 2 | United States |
| 119 | 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 |
| 120 | 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 |
| 121 | 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 |
| 122 | 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 |
| 123 | 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 |
| 124 | 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] | Product Name: IVA337 Product Code: IVA337 INN or Proposed INN: LANIFIBRANOR Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID | Inventiva SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland | ||
| 125 | 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] | Product Name: IVA337 Product Code: IVA337 | Inventiva SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 126 | 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 | ||
| 127 | NCT02558543 (ClinicalTrials.gov) | September 2015 | 31/8/2015 | Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis | Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy Assessment | Scleroderma, Systemic | Drug: Stromal Vascular fraction;Drug: Ringer lactate | Assistance Publique Hopitaux De Marseille | NULL | Terminated | 18 Years | N/A | All | 40 | Phase 2 | France |
| 128 | NCT04387825 (ClinicalTrials.gov) | August 13, 2015 | 10/5/2020 | Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis | Lipograft Safety Enriched With Vascular Stromal Fraction Derived From Adipose Tissue, to Treatment of Digital Joint Fibrosis and Refractory Ischemic Digital Ulcers Caused by Systemic Sclerosis | Systemic Sclerosis | Drug: ADSVF application in the right hand | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | National Council of Science and Technology, Mexico | Completed | 18 Years | N/A | All | 20 | Phase 2 | Mexico |
| 129 | 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 |
| 130 | NCT02480335 (ClinicalTrials.gov) | June 26, 2015 | 15/6/2015 | The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis | The Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital Ulcers | Scleroderma, Systemic | Drug: bosentan | University Medical Center Groningen | Actelion | Completed | 18 Years | N/A | All | 20 | Phase 4 | Netherlands |
| 131 | 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 |
| 132 | NCT02371005 (ClinicalTrials.gov) | June 2015 | 18/2/2015 | Oral Manifestations of Systemic Sclerosis | Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers | Scleroderma, Systemic | Radiation: Cone Beam Computed Tomography (CBCT) | University Hospital, Strasbourg, France | NULL | Terminated | 18 Years | N/A | All | 85 | N/A | France |
| 133 | NCT03692299 (ClinicalTrials.gov) | June 2015 | 20/12/2016 | Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis | Efectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémica | Systemic Sclerosis;Small Intestinal Bacterial Overgrowth | Drug: Saccharomyces Boulardii Oral Tablet;Drug: Metronidazole | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | 65 Years | All | 39 | Phase 4 | Mexico |
| 134 | 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 |
| 135 | NCT02411643 (ClinicalTrials.gov) | March 2015 | 3/3/2015 | Molecular Effects of Topical Calcipotriene on Morphea | Molecular Effects of Topical Calcipotriene on Morphea | Morphea;Localized Scleroderma | Drug: topical calcipotriene 0.005% ointment | Northwestern University | NULL | Terminated | 18 Years | N/A | All | 2 | N/A | United States |
| 136 | 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 |
| 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 | NCT02642146 (ClinicalTrials.gov) | January 2015 | 24/12/2015 | Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study | Raynaud Disease;Systemic Sclerosis;Digital Ulcer | Drug: Calcium Channel Blockers;Drug: Phosphodiesterase Inhibitors;Drug: Endothelin receptor blocker;Drug: Prostanoids;Drug: Other vasodilator | Seoul National University Hospital | NULL | Terminated | 18 Years | N/A | All | 71 | Korea, Republic of | ||
| 139 | 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 |
| 140 | NCT02363478 (ClinicalTrials.gov) | December 2014 | 29/1/2015 | Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc) | Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc) | Systemic Sclerosis | Drug: buspirone | Laikon General District Hospital, Athens | NULL | Completed | 18 Years | 75 Years | All | 22 | Early Phase 1 | Greece |
| 141 | NCT02374320 (ClinicalTrials.gov) | November 2014 | 23/2/2015 | Exparel as a Nerve Block for Severe Hand Pain | Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine | CREST Syndrome;Peripheral Vascular Disease;Raynaud Disease;Scleroderma, Diffuse | Drug: liposomal bupivacaine | Jose Soberon, MD | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 2/Phase 3 | United States |
| 142 | NCT01862926 (ClinicalTrials.gov) | November 2014 | 22/5/2013 | Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD | A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease | Interstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue Disease | Drug: Rituximab;Drug: Cyclophosphamide | Royal Brompton & Harefield NHS Foundation Trust | Imperial College London;University of East Anglia;University College London Hospitals | Completed | 18 Years | 80 Years | All | 104 | Phase 2/Phase 3 | United Kingdom |
| 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 | 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 |
| 145 | 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 |
| 146 | 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 |
| 147 | NCT02213705 (ClinicalTrials.gov) | May 6, 2014 | 17/7/2014 | Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells | Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells | SYSTEMIC SCLERODERMA;ALLOGENEIC MESENCHYMAL STEM CELLS;ADULT | Biological: INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 18 Years | 70 Years | All | 20 | Phase 1/Phase 2 | France |
| 148 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Completed | 18 Years | N/A | All | 81 | Phase 2 | France |
| 149 | NCT01933334 (ClinicalTrials.gov) | October 2013 | 23/8/2013 | Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) | The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) | Systemic Sclerosis | Drug: Pirfenidone | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 63 | Phase 2 | United States;Canada;Italy |
| 150 | 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 |
| 151 | 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 |
| 152 | NCT03561233 (ClinicalTrials.gov) | May 2013 | 7/6/2018 | Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis | Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis | Systemic Sclerosis;Gastroesophageal Reflux;Proton Pubm Inhibitor | Drug: Omeprazole 20mg | Khon Kaen University | Thai Rheumatism Association | Completed | 18 Years | N/A | All | 250 | Phase 1 | NULL |
| 153 | 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 |
| 154 | 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 |
| 155 | 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 |
| 156 | NCT01895244 (ClinicalTrials.gov) | September 2012 | 1/7/2013 | Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis | Highdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation | Scleroderma;Cardiac Involvement;Autologous Stem Cell Transplantation | Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells | University Hospital Tuebingen | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Germany |
| 157 | NCT02169752 (ClinicalTrials.gov) | September 2012 | 6/5/2014 | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Pre-Pulmonary Atrial Hypertension | Drug: Ambrisentan | National Jewish Health | NULL | Terminated | 18 Years | 80 Years | All | 7 | N/A | United States |
| 158 | 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 |
| 159 | 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 |
| 160 | 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 | ||
| 161 | 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 | ||
| 162 | 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 | ||
| 163 | 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] | Trade Name: Imnovid 1 mg hard capsules INN or Proposed INN: Pomalidomide | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 88 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom | ||
| 164 | 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 | ||
| 165 | 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 |
| 166 | NCT02562079 (ClinicalTrials.gov) | March 2012 | 29/12/2014 | Vasculopathy, Inflammation and Systemic Sclerosis | Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation | Systemic Sclerosis | Biological: Blood samples;Biological: Biopsy | University Hospital, Bordeaux | Société Française de Rhumatologie | Completed | 18 Years | 75 Years | All | 350 | N/A | France |
| 167 | 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 |
| 168 | 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 |
| 169 | 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 |
| 170 | NCT02240888 (ClinicalTrials.gov) | October 2011 | 4/9/2014 | Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response | RA;SLE;Vasculitis;Scleroderma;Sjögrens;Syndrome | Biological: 0,5 mg Prevenar i.m.;Biological: 0,5 mg seasonal influenza vaccine i.m. | Region Skane | NULL | Completed | 18 Years | N/A | All | 300 | N/A | Sweden | |
| 171 | NCT01413100 (ClinicalTrials.gov) | September 15, 2011 | 8/8/2011 | Scleroderma Treatment With Autologous Transplant (STAT) Study | A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis | Systemic Scleroderma | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire Administration | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Active, not recruiting | N/A | 70 Years | All | 21 | Phase 2 | United States;Canada |
| 172 | NCT01445821 (ClinicalTrials.gov) | September 15, 2011 | 29/9/2011 | Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial | Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb) | Scleroderma, Systemic | Biological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Fludarabine | Northwestern University | NULL | Terminated | 17 Years | 60 Years | All | 44 | Phase 3 | United States |
| 173 | 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 |
| 174 | JPRN-UMIN000005550 | 2011/06/01 | 23/05/2011 | Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis | Systemic sclerosis | Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies Continue existing conventional therapies | Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine | Rheumatology Keio University,Rheumatology Tokyo Women's Medical University,Dermatology Osaka University | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | |
| 175 | NCT01639573 (ClinicalTrials.gov) | April 2011 | 18/6/2012 | Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic Sclerosis | Campath-1h as Immunoablative Therapy for Children and Adolescents With Treatment Refractory Systemic Sclerosis | Scleroderma | Drug: Campath | Children's Hospital Los Angeles | NULL | Withdrawn | 8 Years | 18 Years | All | 0 | Phase 1/2 | United States |
| 176 | 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 | ||||
| 177 | NCT01309997 (ClinicalTrials.gov) | March 2011 | 1/3/2011 | Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease | A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation | Graft Versus Host Disease;Systemic Scleroderma | Drug: imatinib mesylate;Biological: rituximab | Lee, Stephanie | National Cancer Institute (NCI) | Completed | 2 Years | N/A | All | 72 | Phase 2 | United States |
| 178 | NCT01166139 (ClinicalTrials.gov) | July 2010 | 1/7/2010 | Nilotinib in the Treatment of Systemic Sclerosis | Phase IIA Study of the Safety and Tolerability of the Use of Nilotinib in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Nilotinib (Tasigna) | Hospital for Special Surgery, New York | Rudolph Rupert Scleroderma Program;Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 179 | NCT01072669 (ClinicalTrials.gov) | February 2010 | 19/2/2010 | Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet | Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging | Ischemia | Drug: ambrisentan | Soumya Chatterjee | Gilead Sciences | Completed | 18 Years | 70 Years | All | 20 | N/A | United States |
| 180 | NCT01093885 (ClinicalTrials.gov) | February 2010 | 24/3/2010 | Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis | An Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic Sclerosis | Systemic Sclerosis;Scleroderma | Drug: Ambrisentan | University of Pennsylvania | Gilead Sciences | Completed | 19 Years | 90 Years | All | 15 | N/A | United States |
| 181 | NCT01047072 (ClinicalTrials.gov) | January 2010 | 11/1/2010 | Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis | Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 182 | NCT01042158 (ClinicalTrials.gov) | January 2010 | 4/1/2010 | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Pulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary Hypertension | Drug: tadalafil and ambrisentan upfront combination therapy | Johns Hopkins University | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford University | Completed | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 183 | 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 |
| 184 | NCT00848107 (ClinicalTrials.gov) | September 2009 | 16/2/2009 | Open-Label Study of Oral Treprostinil in Digital Ulcers | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Terminated | 18 Years | N/A | All | 115 | Phase 2 | United States;Canada;United Kingdom |
| 185 | NCT00962923 (ClinicalTrials.gov) | August 2009 | 19/8/2009 | Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc) | Systemic Sclerosis;Mesenchymal Stem Cells | Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC) | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | NULL | Recruiting | 15 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | China | |
| 186 | NCT00936546 (ClinicalTrials.gov) | June 2009 | 9/7/2009 | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis) | Drug: Rituximab | University Hospital, Ghent | NULL | Completed | 18 Years | N/A | All | 3 | Phase 2 | Belgium |
| 187 | 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 |
| 188 | NCT01051960 (ClinicalTrials.gov) | March 2009 | 19/1/2010 | Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan | Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot Study | Systemic Sclerosis;Shortness of Breath;Pulmonary Hypertension | Drug: Ambrisentan | University of California, Los Angeles | Gilead Sciences | Completed | 18 Years | 80 Years | All | 12 | Phase 4 | United States |
| 189 | NCT00764309 (ClinicalTrials.gov) | January 2009 | 1/10/2008 | Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis | An Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial Fibrosis | Scleroderma | Drug: dasatinib | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 47 | Phase 1/Phase 2 | United States |
| 190 | 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 |
| 191 | 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 |
| 192 | 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 |
| 193 | EUCTR2005-003775-21-GB (EUCTR) | 14/08/2008 | 10/11/2005 | Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis | Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis | Systemic sclerosis (also termed 'scleroderma') | Trade Name: Lipitor Product Name: Lipitor | Salford Royal Hospitals NHS Trust | University of Manchester | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 194 | NCT00725361 (ClinicalTrials.gov) | June 2008 | 28/7/2008 | A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma). | A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis. | n Ulcer;Scleroderma, Systemic | Drug: Ambrisentan | Stanford University | NULL | Completed | 18 Years | N/A | All | 20 | N/A | United States |
| 195 | NCT00613171 (ClinicalTrials.gov) | January 2, 2008 | 25/1/2008 | Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis | A Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis | Systemic Sclerosis, Scleroderma | Drug: STI571 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 27 | Phase 2 | United States;Germany;Italy;Switzerland;United Kingdom |
| 196 | EUCTR2007-001508-19-IT (EUCTR) | 06/09/2007 | 29/07/2008 | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | GVH CRONICA ESTESA MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease | Trade Name: GLIVEC INN or Proposed INN: Imatinib | AZIENDA OSPEDALIERA S. CARLO | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 197 | 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 | ||
| 198 | NCT00555581 (ClinicalTrials.gov) | August 2007 | 7/11/2007 | Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis | Phase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Imatinib Mesylate | Hospital for Special Surgery, New York | Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 199 | NCT00512902 (ClinicalTrials.gov) | August 2007 | 6/8/2007 | A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic Sclerosis | Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis | Alveolitis;Systemic Sclerosis | Drug: Imatinib | University of California, Los Angeles | Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
| 200 | NCT00684255 (ClinicalTrials.gov) | August 2007 | 22/5/2008 | Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) | Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc) | Systemic Lupus Erythematosus;Systemic Sclerosis | Procedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: Campath | New York Medical College | NULL | Terminated | 7 Years | 50 Years | All | 1 | Phase 1 | United States |
| 201 | NCT00506831 (ClinicalTrials.gov) | July 2007 | 24/7/2007 | Imatinib in Systemic Sclerosis | A Pilot Study of Imatinib in the Treatment of Refractory Systemic Sclerosis | Scleroderma, Systemic | Drug: Imatinib mesylate | Stanford University | NULL | Completed | 18 Years | 80 Years | All | 9 | Phase 1/Phase 2 | United States |
| 202 | NCT00498615 (ClinicalTrials.gov) | April 2007 | 6/7/2007 | A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon | Efficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon | Raynaud;Scleroderma | Drug: Fasudil | Johns Hopkins University | NULL | Completed | 18 Years | 80 Years | All | 17 | Phase 3 | United States |
| 203 | NCT00622895 (ClinicalTrials.gov) | September 1, 2006 | 22/2/2008 | Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis | Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma;Severe Systemic Sclerosis | Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy | Fred Hutchinson Cancer Research Center | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | N/A | 70 Years | All | 3 | Phase 1/Phase 2 | United States |
| 204 | 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 |
| 205 | NCT00333437 (ClinicalTrials.gov) | May 2006 | 2/6/2006 | Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement | Pulmonary Involvement in Scleroderma: Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients | Scleroderma, Systemic | Drug: Mycophenolate mofetil | University of California, San Francisco | Roche Pharma AG | Completed | 21 Years | 70 Years | All | 7 | N/A | United States |
| 206 | NCT00278525 (ClinicalTrials.gov) | September 2005 | 15/1/2006 | Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma | Trial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized Trial | SYSTEMIC SCLERODERMA | Drug: standard of care;Procedure: stem cell transplantation | Northwestern University | NULL | Completed | N/A | 60 Years | All | 19 | Phase 2 | United States |
| 207 | NCT00860548 (ClinicalTrials.gov) | June 2005 | 11/3/2009 | SCOT Scleroderma Treatment Alternative Registry (STAR Registry) | An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02) | Scleroderma, Systemic;Sclerosis | Drug: currently available therapy in the community | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 19 | N/A | United States |
| 208 | NCT00114530 (ClinicalTrials.gov) | June 2005 | 15/6/2005 | Scleroderma: Cyclophosphamide or Transplantation (SCOT) | A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01) | Scleroderma, Systemic;Sclerosis;Autoimmune Disease | Biological: mHSCT;Drug: cyclophosphamide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 75 | Phase 2/Phase 3 | United States;Canada |
| 209 | NCT00282425 (ClinicalTrials.gov) | May 2005 | 24/1/2006 | Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Scleroderma | Biological: Hematopoietic stem cell transplantation | Richard Burt, MD | NULL | Terminated | 18 Years | 55 Years | Both | 8 | Phase 1 | United States |
| 210 | NCT00319696 (ClinicalTrials.gov) | July 8, 2004 | 27/4/2006 | Bosentan in Digital Ulcers | Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers | Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg | Actelion | NULL | Completed | 18 Years | N/A | All | 116 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom |
| 211 | NCT00025818 (ClinicalTrials.gov) | May 2001 | 26/10/2001 | Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome | Keratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, Systemic | Drug: Ophthalmic Emulsion | Allergan | NULL | Completed | 18 Years | N/A | Both | 290 | Phase 3 | United States | |
| 212 | NCT00501995 (ClinicalTrials.gov) | February 2001 | 13/7/2007 | High Dose Cyclophosphamide for Treatment of Scleroderma | High Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma) | Scleroderma | Drug: IV Cyclophosphamide | Johns Hopkins University | NULL | Completed | 18 Years | 70 Years | All | 6 | Phase 3 | United States |
| 213 | 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 |
| 214 | 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 |
| 215 | NCT00058578 (ClinicalTrials.gov) | June 1999 | 8/4/2003 | Stem Cell Transplant to Treat Patients With Systemic Sclerosis | Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body Irradiation | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States |