51. 全身性強皮症 Scleroderma Clinical trials / Disease details


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217

  
54 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-005116-21-PL
(EUCTR)
27/09/202125/06/2021FT011 for SclerodermaA phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma diffuse systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: FT011 100 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Product Name: FT011 200 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Certa Therapeutics Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Spain;Poland;Ukraine;Australia;Russian Federation;Netherlands
2EUCTR2020-005116-21-ES
(EUCTR)
22/07/202122/07/2021FT011 for SclerodermaA phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma diffuse systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: FT011 100 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Product Name: FT011 200 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Certa Therapeutics Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Poland;Spain;Ukraine;Australia;Russian Federation;Netherlands
3EUCTR2019-000906-31-IT
(EUCTR)
25/02/202022/01/2021Efficacy 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 - NA efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: PRIVIGEN - 100 MG/ML - SOLUZIONE PER INFUSIONE USO ENDOVENOSO FLACONCINO(VETRO) 1 FLACONCINO DA 100 ML
Product Name: Immunoglobulina normale umana per somministrazione endovenosa
Product Code: [IgPro10]
CSL BEHRING GMBHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
4JPRN-JapicCTI-194761
23/5/201917/05/2019A Phase 3 study of KHK4827 in patients with systemic sclerosisA Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickening Systemic sclerosisIntervention name : KHK4827
INN of the intervention : Brodalumab
Dosage And administration of the intervention : 210 mg Q2W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 210 mg Q2W, SC
Kyowa Kirin Co., Ltd.NULLcomplete1870BOTH100Phase 3Japan
5JPRN-jRCTc071190041
04/01/201909/01/2020A clinical trial of autologous stem cell transplantation for severe systemic sclerosisA single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis systemic sclerosisAfter peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted.Akashi KoichiNULLNot Recruiting>= 16age old< 65age oldBoth12Phase 2Japan
6EUCTR2017-000372-29-IT
(EUCTR)
25/09/201827/01/2021Clinical Trial to evaluate efficacy and eafety of Lenabasum in for the diffuse dutaneous systemic sclerosis, a disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5mg Powder in Capsule
Product Code: [JBT-101]
INN or Proposed INN: lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: [JBT-101]
Other descriptive name: resunab, ajulemic acid, anabasum
CORBUS PHARMACEUTICALS, INCNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
7NCT03726398
(ClinicalTrials.gov)
September 1, 201821/10/2018CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PHCompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated Interstitial Lung DiseasE and Pulmonary Hypertension (PH): The CRuSADE PH StudyInterstitial Lung Disease;Scleroderma;Pulmonary HypertensionDrug: Opsumit 10 Mg TabletFranz Rischard, DONational Jewish Health;University of PittsburghRecruiting18 YearsN/AAll26Phase 2/Phase 3United States
8EUCTR2017-000372-29-ES
(EUCTR)
25/04/201802/02/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of;Sweden
9NCT03708718
(ClinicalTrials.gov)
December 21, 20178/10/2018Prednisolone in Early Diffuse Systemic SclerosisA 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 SclerosisDrug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'Prof. Ariane herrickVersus ArthritisCompleted18 YearsN/AAll35Phase 2United Kingdom
10NCT03398837
(ClinicalTrials.gov)
December 18, 20175/1/2018Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsuleCorbus Pharmaceuticals Inc.NULLTerminated18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
11JPRN-JapicCTI-173760
10/11/201707/11/2017Tocilizumab LTE study in patients with SScA PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic sclerosisIntervention name : tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/week, SC
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
CHUGAI PHARMACEUTICAL CO., LTDNULLcomplete18BOTH18Phase 3Japan
12JPRN-JapicCTI-173686
06/10/201729/08/2017A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosisA Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis systemic sclerosisIntervention name : KHK4827
INN of the intervention : brodalumab
Dosage And administration of the intervention : SC, 210 mg Q2W
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcomplete1870BOTH6Phase 1Japan
13JPRN-UMIN000026859
2017/04/1005/04/2017Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosisEffectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis - Therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in SSC systemic sclerosisacotinamaide hydrpchloride
100 mg tablets, 3 times/day, 28 days
trimebutine maleateon
100 mg tablets, 3 times/day, 28 days
Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of MedicineJapanese Cross Society Matsue JCS HospitalShimane Prefecture central HospitalPending20years-oldNot applicableMale and Female40Phase 3Japan
14EUCTR2016-002984-32-IT
(EUCTR)
16/02/201705/02/2018NDTreatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - ND SISTEMIC SCLEROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
INN or Proposed INN: ILOPROST TROMETAMOL
Other descriptive name: ILOPROST SALE DI TROMETAMOLO
Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
Product Code: ND
INN or Proposed INN: ILOPROST TROMETAMOL
Other descriptive name: ILOPROST SALE DI TROMETAMOLO
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
238Phase 4Italy
15EUCTR2015-000424-28-IE
(EUCTR)
17/10/201619/08/2016A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
16EUCTR2015-002586-39-IT
(EUCTR)
27/07/201606/02/2018Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
Product Name: Metoclopramide
Product Code: /
INN or Proposed INN: METOCLOPRAMIDE
Other descriptive name: METOCLOPRAMIDE
MEDAC GMBHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy
17EUCTR2015-005100-28-IT
(EUCTR)
18/07/201617/01/2022A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in patients with cutaneous lesions in 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. - A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in p Fibrotic and atrophic cutaneous lesions in localized scleroderma diseases.
MedDRA version: 20.0;Level: HLT;Classification code 10039711;Term: Scleroderma and associated disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: PLACENTEX ¿5.625 mg/3 ml soluzione iniettabile¿
Product Name: PLACENTEX ¿ Polydeoxyribonucleotide 5.625 mg/3 ml
INN or Proposed INN: POLYDEOXYRIBONUCLEOTIDES
Other descriptive name: PLACENTEX ® Polydeoxyribonucleotide
MASTELLI SRLNULLNot RecruitingFemale: yes
Male: yes
45Phase 4Italy
18NCT02745145
(ClinicalTrials.gov)
May 31, 201615/4/2016Abituzumab in SSc-ILDA 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 DiseaseDrug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years75 YearsAll24Phase 2United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
19EUCTR2015-000424-28-GR
(EUCTR)
26/01/201630/12/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
20JPRN-JapicCTI-152963
08/1/201609/07/2015Phase III Study of Tocilizumab in Patients with Systemic SclerosisA 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 SclerosisIntervention name : Tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo/W, SC
Chugai Pharmaceutical Co., Ltd.F.Hoffmann-La Roche Ltdcomplete18BOTH210Phase 3Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.
21EUCTR2015-000424-28-NL
(EUCTR)
22/12/201521/09/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
22EUCTR2015-000424-28-HR
(EUCTR)
18/12/201501/02/2016A 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 A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
23EUCTR2015-000424-28-DE
(EUCTR)
02/11/201527/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
24EUCTR2015-000424-28-LT
(EUCTR)
14/10/201529/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
25EUCTR2015-000424-28-HU
(EUCTR)
22/09/201511/08/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
26EUCTR2015-000424-28-DK
(EUCTR)
10/09/201517/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
27EUCTR2015-000424-28-IT
(EUCTR)
07/09/201530/09/2021A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO ASSESS THEEFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - NA Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE
Product Name: tocilizumab
Product Code: [RO487-7533/F10-04]
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan;United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland
28EUCTR2015-000424-28-BE
(EUCTR)
07/09/201528/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
29EUCTR2015-000424-28-ES
(EUCTR)
07/08/201504/08/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
30EUCTR2015-000424-28-PT
(EUCTR)
31/07/201530/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
31EUCTR2014-001353-16-GB
(EUCTR)
17/04/201503/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 m
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
32EUCTR2014-001353-16-DE
(EUCTR)
19/02/201516/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
33EUCTR2014-001353-16-CZ
(EUCTR)
22/01/201506/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
34EUCTR2014-001353-16-IT
(EUCTR)
19/01/201514/05/2015Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
35EUCTR2014-001353-16-NL
(EUCTR)
31/12/201420/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
36EUCTR2014-001353-16-HU
(EUCTR)
30/12/201414/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan
37EUCTR2014-001353-16-ES
(EUCTR)
22/12/201403/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
38EUCTR2014-001353-16-BE
(EUCTR)
09/12/201421/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
39JPRN-UMIN000015495
2014/04/0122/10/2014Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapiesOsaka UniversityNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not applicableJapan
40JPRN-jRCTs031180370
12/11/201318/03/2019Clinical trial of tocilizumab for skin fibrosis in systemic sclerosisClinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six monthsYoshizaki AyumiSato ShinichiComplete>= 20age old< 80age oldBoth5Phase 2Japan
41JPRN-UMIN000012214
2013/11/0505/11/2013Clinical trial of tocilizumab for skin fobrosis in systemic sclerosisClinical trial of tocilizumab for skin fobrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
The University of TokyoNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not applicableJapan
42JPRN-JapicCTI-132176
01/6/2013Bosentan DUA prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc) Digital ulcers associated with systemic sclerosisIntervention name : Ro47-0203 / ACT-050088
INN of the intervention : Bosentan
Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5.
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.NULL18BOTH20Phase 3NULL
43EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A 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 diseaseA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
44EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A 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 diseaseA 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 CorporationNULLNot 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): noFrance;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
45EUCTR2011-001460-22-GB
(EUCTR)
19/01/201217/10/2011A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A Systemic Sclerosis (SSc)
MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Germany;United Kingdom
46NCT01474122
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, 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 SclerosisDigital UlcersDrug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: PlaceboActelionNULLTerminated18 YearsN/AAll265Phase 3United 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
47EUCTR2011-001460-22-DE
(EUCTR)
28/11/201120/10/2011A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A Systemic Sclerosis (SSc)
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
86Phase 2/3France;United States;Canada;Germany;United Kingdom
48NCT02240888
(ClinicalTrials.gov)
October 20114/9/2014Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody ResponseRA;SLE;Vasculitis;Scleroderma;Sjögrens;SyndromeBiological: 0,5 mg Prevenar i.m.;Biological: 0,5 mg seasonal influenza vaccine i.m.Region SkaneNULLCompleted18 YearsN/AAll300N/ASweden
49JPRN-UMIN000005550
2011/06/0123/05/2011Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosisRandomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis - The assessment of tocilizumab for the treatment of systemic sclerosis Systemic sclerosisAdministrate 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 MedicineRheumatology Keio University,Rheumatology Tokyo Women's Medical University,Dermatology Osaka UniversityComplete: follow-up complete20years-old65years-oldMale and Female24Phase 2Japan
50NCT01257802
(ClinicalTrials.gov)
May 20119/12/2010GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesGnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesLupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial DiffuseDrug: depot leuprolide acetate 3.75 mg;Drug: PlaceboJoseph MccuneNational Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Terminated18 Years40 YearsFemale14Phase 3United States
51EUCTR2007-004669-17-DE
(EUCTR)
10/07/200813/03/2008A 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 sclerosisA 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
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Glivec 100 mg Filmtabletten
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
27Germany;Italy;United Kingdom
52NCT00319696
(ClinicalTrials.gov)
July 8, 200427/4/2006Bosentan in Digital UlcersLong-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital UlcersDigital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mgActelionNULLCompleted18 YearsN/AAll116Phase 3United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom
53NCT02800993
(ClinicalTrials.gov)
October 200313/6/2016Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisSystemic Sclerosis;Digital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth188Phase 3United States;Canada
54NCT00077584
(ClinicalTrials.gov)
October 200310/2/2004Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisDigital Ulcers;Systemic SclerosisDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth188Phase 3United States;Canada