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
| 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 | NCT04948554 (ClinicalTrials.gov) | March 10, 2023 | 4/6/2021 | A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) | A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis | Systemic Sclerosis With and Without Interstitial Lung Disease | Biological: MK-2225;Biological: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 1 | United States;Canada |
| 2 | NCT04789850 (ClinicalTrials.gov) | February 2, 2023 | 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 | Recruiting | 18 Years | N/A | All | 74 | Phase 2 | France |
| 3 | NCT05462522 (ClinicalTrials.gov) | January 16, 2023 | 14/7/2022 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis | A Phase Ib, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Participants With Systemic Sclerosis | Systemic Sclerosis | Drug: RO7303509;Drug: Placebo | Genentech, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 100 | Phase 1 | United States;Belgium;France;Israel;Poland;Puerto Rico;Spain |
| 4 | NCT04356287 (ClinicalTrials.gov) | January 5, 2023 | 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 | Medical University of South Carolina;McGill University Health Centre/Research Institute of the McGill University Health Centre;Université de Montréal;Assistance Publique - Hôpitaux de Paris;Centre hospitalier de l'Université de Montréal (CHUM);University Paris 7 - Denis Diderot | Recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | Canada |
| 5 | NCT05559580 (ClinicalTrials.gov) | November 24, 2022 | 26/9/2022 | A Study in People With Systemic Sclerosis to Test Whether BI 685509 Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms | A Phase II, Randomised, Placebo-controlled, Double-blind, Parallel Group, Efficacy and Safety Study of at Least 48 Weeks of Oral BI 685509 Treatment in Adults With Early Progressive Diffuse Cutaneous Systemic Sclerosis | Scleroderma, Systemic | Drug: BI 685509;Drug: Placebo | Boehringer Ingelheim | NULL | Recruiting | 18 Years | N/A | All | 200 | Phase 2 | Australia;Austria;Belgium;Canada;China;Czechia;Finland;France;Greece;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;New Zealand;Poland;Romania;Singapore;Spain;Sweden;Thailand |
| 6 | NCT05416697 (ClinicalTrials.gov) | November 9, 2022 | 9/6/2022 | Effectiveness of Cannabinoids on Appetite in Scleroderma | Effectiveness of Cannabinoid on Appetite, Sleep Quality, Quality of Life, Joint Pain, and Cytokine Level in Systemic Sclerosis Patients: a Randomized Placebo-controlled Trial | Systemic Sclerosis;Malnutrition;Loss of Appetite | Drug: CBD oil;Drug: Placebo | Khon Kaen University | NULL | Recruiting | 18 Years | 65 Years | All | 40 | Phase 3 | Thailand |
| 7 | NCT05339087 (ClinicalTrials.gov) | October 24, 2022 | 14/4/2022 | Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH | Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA) | Pulmonary Vascular Disorder;Primary Pulmonary Hypertension;Systemic Sclerosis;Other Systemic Involvement of Connective Tissue | Drug: Riociguat Oral Tablet;Other: Placebo | Heidelberg University | Merck Sharp & Dohme LLC | Recruiting | 18 Years | N/A | All | 70 | Phase 2 | Germany |
| 8 | JPRN-jRCT2031210521 | 20/07/2022 | 26/12/2021 | Phase 3 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 | (1)MT-0551 group Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks. (2)Placebo group Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks. | Kondou Kazuoki | NULL | Recruiting | >= 20age old | <= 80age old | Both | 80 | Phase 3 | Japan |
| 9 | EUCTR2021-005206-10-DE (EUCTR) | 19/07/2022 | 07/04/2022 | A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease | 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) - The ATHENA-SSc-ILD Study | Systemic sclerosis associated with interstitial lung disease MedDRA version: 21.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PRA023 INN or Proposed INN: tulisokibart Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Norway;Germany;Netherlands | ||
| 10 | NCT05098704 (ClinicalTrials.gov) | June 22, 2022 | 4/10/2021 | Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk | Phase II/III Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon | Scleroderma;Systemic Sclerosis | Drug: clopidogrel treatment;Drug: Placebo | University Hospital, Bordeaux | Ministry for Health and Solidarity, France | Recruiting | 18 Years | 85 Years | All | 90 | Phase 2/Phase 3 | France |
| 11 | EUCTR2021-005206-10-ES (EUCTR) | 12/04/2022 | 02/02/2022 | A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease. | 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). - The ATHENA-SSc-ILD Study. | Systemic sclerosis associated with interstitial lung disease. MedDRA version: 21.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Norway | ||
| 12 | 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. | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Spain;Switzerland;United Kingdom |
| 13 | EUCTR2020-005764-62-PL (EUCTR) | 31/01/2022 | 05/01/2022 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 14 | EUCTR2020-005764-62-NL (EUCTR) | 31/01/2022 | 25/11/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 15 | EUCTR2021-000230-33-IT (EUCTR) | 26/01/2022 | 17/08/2021 | TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE VERSUS PLACEBO IN EARLY SYSTEMIC SCLEROSIS (SSc) | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADD-ON TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE IN EARLY SYSTEMIC SCLEROSIS (SSc)- HYDROXYSSc - HYDROXYSSc | Systemic Sclerosis (SSc) is a rare and orphan disease (DPCM 12 gennaio 2017-GU SG n°65-S.O. n°15 - 18/03/2017), characterized by immunological, vascular and fibrotic abnormalities. The estimated incidence is 18 to 20 cases per million population year and a prevalence of 100 to 300 cases per million population. In Europe the prevalence rate is estimated around 200 per million while in the Italian population around 20000 persons suffer from this form of autoimmune disease. MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Idrossiclorochina solfato Product Code: [N/A] INN or Proposed INN: idrossiclorochina solfato | UMBERTO I - POLICLINICO DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 151 | Phase 3 | Italy | ||
| 16 | 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 | Terminated | 18 Years | 80 Years | All | 3 | Phase 1 | United States |
| 17 | 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 | Terminated | 18 Years | 75 Years | All | 13 | Phase 2 | United States;United Kingdom |
| 18 | NCT03211793 (ClinicalTrials.gov) | October 6, 2021 | 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 | Recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Netherlands |
| 19 | EUCTR2020-005764-62-IT (EUCTR) | 29/09/2021 | 30/08/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: HZN-825 Product Code: [HZN-825] | HORIZON THERAPEUTICS IRELAND DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Korea, Democratic People's Republic of;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 20 | EUCTR2020-005116-21-PL (EUCTR) | 27/09/2021 | 25/06/2021 | FT011 for Scleroderma | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Spain;Poland;Ukraine;Australia;Russian Federation;Netherlands | ||
| 21 | 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 |
| 22 | EUCTR2020-000134-17-PL (EUCTR) | 14/09/2021 | 18/08/2021 | A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Canada;Belgium;Spain;Poland;Germany;United Kingdom;Italy | ||
| 23 | EUCTR2020-005764-62-GR (EUCTR) | 13/09/2021 | 09/07/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of | ||
| 24 | EUCTR2020-005764-62-PT (EUCTR) | 24/08/2021 | 19/08/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of | ||
| 25 | EUCTR2020-005764-62-AT (EUCTR) | 16/08/2021 | 15/06/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 26 | EUCTR2020-005764-62-ES (EUCTR) | 11/08/2021 | 11/08/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of | ||
| 27 | EUCTR2020-005764-62-DE (EUCTR) | 09/08/2021 | 14/06/2021 | A Study 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 MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: HZN-825 INN or Proposed INN: HZN-825 | Horizon Therapeutics Ireland DAC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 28 | 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 |
| 29 | EUCTR2020-005116-21-ES (EUCTR) | 22/07/2021 | 22/07/2021 | FT011 for Scleroderma | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Poland;Spain;Ukraine;Australia;Russian Federation;Netherlands | ||
| 30 | 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;Austria;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Switzerland;United Kingdom |
| 31 | JPRN-jRCT2051200133 | 31/03/2021 | 12/02/2021 | 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 | Group A: Guselkumab Dose 1 Guselkumab Dose 1 will be administered intravenously. Group A: Guselkumab Dose 2 Guselkumab Dose 2 will be administered subcutaneously. Group B: Placebo Placebo will be administered intravenously or subcutaneously. | Numaguchi Hirotaka | NULL | Not Recruiting | >= 18age old | <= 75age old | Both | 56 | Phase 2 | Japan |
| 32 | 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 | Active, not recruiting | 18 Years | 75 Years | All | 56 | Phase 2 | Japan |
| 33 | 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 | Active, not recruiting | 18 Years | N/A | All | 72 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 34 | EUCTR2020-000134-17-DE (EUCTR) | 27/01/2021 | 06/10/2020 | A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Germany;United Kingdom;Italy | ||
| 35 | 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 |
| 36 | EUCTR2020-000134-17-GB (EUCTR) | 23/12/2020 | 05/08/2020 | A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Dersimelagon Product Code: MT-7117 INN or Proposed INN: Dersimelagon Other descriptive name: MT-7117 | Mitsubishi Tanabe Pharma Development America (MTDA), Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 37 | EUCTR2020-000134-17-IT (EUCTR) | 18/12/2020 | 15/06/2021 | A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-ControlledParallel-Group study to determine how safe, effective and tolerable MT7117 is in subjects with Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis - NA | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Dersimelagon Product Code: [MT-7117] Other descriptive name: A novel synthetic, orally-administered, non-peptide small molecule, which acts as an agonist of the melanocortin-1 receptor (MC1R) | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Canada;Spain;Belgium;Germany;United Kingdom;Italy | ||
| 38 | EUCTR2020-002081-13-PL (EUCTR) | 09/12/2020 | 30/09/2020 | A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc). | A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) | Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248 | Gesynta Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Poland;Netherlands;United Kingdom | ||
| 39 | EUCTR2020-002081-13-NL (EUCTR) | 02/11/2020 | 17/08/2020 | A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc). | A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in subjects with systemic sclerosis (SSc) | Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248 | Gesynta Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Poland;Netherlands;United Kingdom | ||
| 40 | 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 | Completed | 18 Years | 85 Years | All | 75 | Phase 2 | Norway |
| 41 | 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 |
| 42 | EUCTR2020-002081-13-GB (EUCTR) | 08/09/2020 | 21/07/2020 | A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc). | A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) | Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GS-248 Product Code: GS-248 INN or Proposed INN: GS-248 | Gesynta Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United Kingdom | ||
| 43 | EUCTR2019-000906-31-DE (EUCTR) | 01/07/2020 | 31/10/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 44 | EUCTR2019-004400-35-NO (EUCTR) | 24/06/2020 | 04/03/2020 | The ReSScue trial. Aiming to Reduce disease-related gastro-intestinal symptoms in patients with Systemic Sclerosis by repeat intestinal infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Phase II, randomized, double-blinded placebo-controlled 12 week study followed by a 14 week blinded extension with open label oral ACHIM capsules. | The ReSScue trial. Aiming to Reduce disease-related gastro-intestinal symptoms in patients with Systemic Sclerosis by repeat intestinal infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Phase II, randomized, double-blinded placebo-controlled 12 week study followed by a 14 week blinded extension with open label oral ACHIM capsules. | Systemic sclerosis (SSc) is a rare, complex, multi-organ disorder characterized by immune-mediated inflammation, progressive organ fibrosis and vascular pathology leading to small vessel obliteration. Gastrointestinal tract (GIT) affliction occurs in 9/10 SSc patients, involves all parts of the GIT and impairs key GIT functions such as motility, absorption and sphincter control. GIT symptoms impact quality of life in SSc, and severe GIT afflictions are among the leading causes of death in SSc. MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: ACHIM capsules INN or Proposed INN: Sodium chloride solution Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% Product Name: ACHIM INN or Proposed INN: Sodium chloride solution Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Oslo University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | Norway | ||
| 45 | 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;Puerto Rico |
| 46 | EUCTR2019-000906-31-GB (EUCTR) | 22/05/2020 | 29/10/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 47 | 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 |
| 48 | EUCTR2019-000906-31-BE (EUCTR) | 19/03/2020 | 09/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 49 | EUCTR2019-000906-31-IT (EUCTR) | 25/02/2020 | 22/01/2021 | 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 - 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 GMBH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 50 | EUCTR2019-000906-31-PL (EUCTR) | 31/01/2020 | 06/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany | ||
| 51 | 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 |
| 52 | 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 |
| 53 | EUCTR2019-000906-31-ES (EUCTR) | 16/12/2019 | 20/12/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 188 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 54 | EUCTR2019-003203-35-GB (EUCTR) | 13/12/2019 | 05/09/2019 | NA | A Phase 2, single-center, randomised, double-blind, placebo-controlled, cross-over, cold challenge study investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc) | Systemic sclerosis (SSc)Raynaud’s phenomenon (RP) MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: NA Product Code: C21 INN or Proposed INN: NA Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt | Vicore Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 2 | United Kingdom | ||
| 55 | EUCTR2019-000906-31-FR (EUCTR) | 03/12/2019 | 08/11/2019 | Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc) | A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis | efficacy and safety in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous (IV) administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany | ||
| 56 | EUCTR2019-002036-90-DE (EUCTR) | 02/12/2019 | 02/10/2019 | Study to test effectiveness and safety of the drug Dupilumab in patients with localized scleroderma | A randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma - DupiMorph | Localized scleroderma MedDRA version: 21.1;Level: LLT;Classification code 10009206;Term: Circumscribed scleroderma;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10027979;Term: Morphea;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Dupilumab Product Code: Dupilumab INN or Proposed INN: Dupilumab Other descriptive name: SAR231893 | University of Cologne | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Germany | ||
| 57 | 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 |
| 58 | 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 |
| 59 | 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 | Completed | 18 Years | N/A | All | 20 | Phase 2 | Greece |
| 60 | EUCTR2015-004613-24-BE (EUCTR) | 17/07/2019 | 18/04/2019 | Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. | Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early | (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Solu-Medrol Product Name: methylprednisolon INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Radboudumc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Belgium;Netherlands | ||
| 61 | 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 |
| 62 | NCT03919799 (ClinicalTrials.gov) | June 26, 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, a Sanofi Company | NULL | Terminated | 18 Years | 100 Years | All | 60 | Phase 2 | United States |
| 63 | JPRN-JapicCTI-194761 | 23/5/2019 | 17/05/2019 | A Phase 3 study of KHK4827 in patients with systemic sclerosis | A Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickening | Systemic sclerosis | Intervention name : KHK4827 INN of the intervention : Brodalumab Dosage And administration of the intervention : 210 mg Q2W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : 210 mg Q2W, SC | Kyowa Kirin Co., Ltd. | NULL | complete | 18 | 70 | BOTH | 100 | Phase 3 | Japan |
| 64 | 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 |
| 65 | EUCTR2018-001817-33-BE (EUCTR) | 05/04/2019 | 23/01/2019 | A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis | A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis | Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Belgium;Germany;United Kingdom;Italy | ||
| 66 | EUCTR2018-001817-33-DE (EUCTR) | 29/03/2019 | 23/01/2019 | A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis | A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis | Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Belgium;Germany;United Kingdom;Italy | ||
| 67 | EUCTR2018-001817-33-IT (EUCTR) | 20/03/2019 | 25/01/2021 | A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis | A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis - - | Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: GLPG1690 Product Code: [G451990] Other descriptive name: GLPG1690 | GALAPAGOS NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Belgium;Germany;United Kingdom;Italy | ||
| 68 | 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 |
| 69 | EUCTR2018-001817-33-GB (EUCTR) | 14/01/2019 | 20/11/2018 | A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis | A Phase 2a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of orally administered GLPG1690 for 24 weeks in subjects with systemic sclerosis | Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: GLPG1690 Product Code: G451990 INN or Proposed INN: Not applicable Other descriptive name: GLPG1690 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 70 | 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 |
| 71 | 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 |
| 72 | 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 |
| 73 | EUCTR2017-000372-29-PL (EUCTR) | 28/09/2018 | 02/07/2018 | A study of safety and efficacy of lenabasum in Systemic Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis | Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 74 | EUCTR2017-000372-29-IT (EUCTR) | 25/09/2018 | 27/01/2021 | Clinical 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, INC | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 75 | EUCTR2016-003417-95-NL (EUCTR) | 18/09/2018 | 09/07/2018 | Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. | A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. | Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: GSK2330811 Solution for Injection, 100mg/ml Product Code: GSK2330811 INN or Proposed INN: GSK2330811 Other descriptive name: GSK2330811 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Netherlands;United Kingdom | ||
| 76 | 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 |
| 77 | EUCTR2017-000372-29-NL (EUCTR) | 21/06/2018 | 24/01/2018 | A study of safety and efficacy of lenabasum in Systemic Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis | Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of | ||
| 78 | 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 |
| 79 | EUCTR2017-000372-29-ES (EUCTR) | 25/04/2018 | 02/02/2018 | A study of safety and efficacy of lenabasum in Systemic Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis | Systemic Sclerosis (SSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Lenabasum 5 mg Powder in Capsule Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum 20 mg Powder in Capsule Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of;Sweden | ||
| 80 | EUCTR2017-000372-29-GB (EUCTR) | 20/03/2018 | 07/12/2017 | A study of safety and efficacy of lenabasum in Systemic Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis | Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 81 | EUCTR2017-000372-29-DE (EUCTR) | 07/03/2018 | 13/12/2017 | A study of safety and efficacy of lenabasum in Systemic Sclerosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis | Systemic Sclerosis (SSc) MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 82 | 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 |
| 83 | 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 |
| 84 | 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 |
| 85 | 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 | Completed | 18 Years | N/A | All | 51 | Phase 2 | United States |
| 86 | 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 |
| 87 | 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. | Active, not recruiting | 18 Years | 70 Years | All | 17 | Phase 1/Phase 2 | United States;Canada |
| 88 | 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 | ||
| 89 | EUCTR2015-000392-28-CZ (EUCTR) | 27/06/2017 | 27/04/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 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 | EUCTR2015-000392-28-HU (EUCTR) | 08/06/2017 | 26/04/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 92 | 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 |
| 93 | EUCTR2015-000392-28-NO (EUCTR) | 02/06/2017 | 15/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Norway KS | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden | ||
| 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 | Phase 2 | Netherlands;Italy;United Kingdom;Slovenia;Bulgaria;Switzerland;Germany;Spain | ||
| 95 | EUCTR2015-000392-28-AT (EUCTR) | 12/05/2017 | 31/03/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia | ||
| 96 | EUCTR2015-000392-28-SE (EUCTR) | 08/05/2017 | 24/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel | ||
| 97 | 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 |
| 98 | EUCTR2015-000392-28-FI (EUCTR) | 21/02/2017 | 10/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 99 | EUCTR2015-002586-39-BE (EUCTR) | 19/01/2017 | 14/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Switzerland;Italy;United Kingdom;Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany | ||
| 100 | EUCTR2016-003417-95-GB (EUCTR) | 13/01/2017 | 24/10/2016 | Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. | A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. | Systemic sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: GSK2330811 Solution for Injection, 100mg/ml Product Code: GSK2330811 INN or Proposed INN: GSK2330811 Other descriptive name: GSK2330811 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Netherlands;United Kingdom | ||
| 101 | 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 |
| 102 | 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 |
| 103 | EUCTR2016-001028-80-IT (EUCTR) | 19/12/2016 | 05/11/2020 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study - NA | Systemic sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NA Product Code: SAR156597 INN or Proposed INN: non applicabile | SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 2 | United States;Estonia;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Romania;Germany | ||
| 104 | JPRN-UMIN000024818 | 2016/12/12 | 14/11/2016 | The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis | The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis - The efficacy and safety of BTX-B on digital ulcers in patients with SSc | digital ulcers in systemic sclerosis patients | placebo subcutaneously injection into hands with digital ulcers botulinum toxin type B subcutaneously injection into hands with digital ulcers | Gunma University Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 105 | 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 |
| 106 | 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 |
| 107 | EUCTR2016-001028-80-DE (EUCTR) | 08/11/2016 | 18/07/2016 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study | Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 2 | United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany | ||
| 108 | EUCTR2015-002586-39-GB (EUCTR) | 18/10/2016 | 19/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 109 | EUCTR2015-000424-28-IE (EUCTR) | 17/10/2016 | 19/08/2016 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 110 | EUCTR2016-001028-80-EE (EUCTR) | 04/10/2016 | 20/09/2016 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study | Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany | ||
| 111 | EUCTR2015-002586-39-PT (EUCTR) | 03/10/2016 | 06/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | France;United States;Portugal;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 112 | 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 |
| 113 | EUCTR2016-001028-80-AT (EUCTR) | 30/09/2016 | 27/07/2016 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study | Systemic sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany | ||
| 114 | EUCTR2016-001028-80-BE (EUCTR) | 26/09/2016 | 02/08/2016 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | Efficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study | Systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: SAR156597 | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany | ||
| 115 | EUCTR2015-002586-39-HU (EUCTR) | 20/09/2016 | 12/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 116 | EUCTR2015-002586-39-FR (EUCTR) | 13/09/2016 | 21/07/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;United States;France;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 117 | 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 |
| 118 | EUCTR2015-005023-11-IT (EUCTR) | 29/08/2016 | 23/02/2018 | Abituzumab in SSc-ILD | A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS | Systemic sclerosis-associated interstitial lung disease (SSc-ILD) MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Abituzumab Product Code: EMD 525797 INN or Proposed INN: abituzumab | MERCK KGAA | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;United Kingdom;Italy | ||
| 119 | EUCTR2015-002586-39-DE (EUCTR) | 03/08/2016 | 29/06/2016 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride INN or Proposed INN: TERGURIDE HYDROGENMALEATE | medac GmbH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 120 | EUCTR2015-002586-39-IT (EUCTR) | 27/07/2016 | 06/02/2018 | Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis | Diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Terguride Product Code: / INN or Proposed INN: TERGURIDE HYDROGENMALEATE Product Name: Terguride Product Code: / INN or Proposed INN: TERGURIDE HYDROGENMALEATE Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL Product Name: Metoclopramide Product Code: / INN or Proposed INN: METOCLOPRAMIDE Other descriptive name: METOCLOPRAMIDE | MEDAC GMBH | NULL | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 121 | 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 | ||
| 122 | 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 | ||
| 123 | 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 | ||
| 124 | EUCTR2015-000392-28-IE (EUCTR) | 27/06/2016 | 13/04/2016 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 125 | 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 | ||
| 126 | 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 |
| 127 | EUCTR2015-004613-24-NL (EUCTR) | 30/05/2016 | 13/04/2016 | Hit hard and early | Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized double-blind placebo-controlled trial. - Hit hard and early | (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: methylprednisolon INN or Proposed INN: methylprednisolon Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE | Radboudumc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 128 | EUCTR2015-000392-28-PL (EUCTR) | 09/03/2016 | 21/01/2016 | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim RCV GmbH&Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 129 | 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 |
| 130 | NCT02588625 (ClinicalTrials.gov) | February 2016 | 26/10/2015 | A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc) | A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc) | Scleroderma | Drug: BMS-986020;Other: Placebo | Bristol-Myers Squibb | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States;Canada;Poland;United Kingdom;France |
| 131 | EUCTR2015-000424-28-GR (EUCTR) | 26/01/2016 | 30/12/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 132 | JPRN-JapicCTI-152963 | 08/1/2016 | 09/07/2015 | Phase III Study of Tocilizumab in Patients with Systemic Sclerosis | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis | Intervention name : Tocilizumab INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg/W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo/W, SC | Chugai Pharmaceutical Co., Ltd. | F.Hoffmann-La Roche Ltd | complete | 18 | BOTH | 210 | Phase 3 | Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc. | |
| 133 | EUCTR2015-000392-28-PT (EUCTR) | 08/01/2016 | 14/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 134 | 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 |
| 135 | EUCTR2015-000392-28-IT (EUCTR) | 23/12/2015 | 08/06/2021 | 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) - SENSCIS¿ | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;Portugal;United States;Greece | ||
| 136 | EUCTR2015-000424-28-NL (EUCTR) | 22/12/2015 | 21/09/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 137 | EUCTR2015-000424-28-HR (EUCTR) | 18/12/2015 | 01/02/2016 | 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 | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 138 | EUCTR2015-000392-28-FR (EUCTR) | 11/12/2015 | 14/12/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 139 | EUCTR2015-000392-28-BE (EUCTR) | 08/12/2015 | 25/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China | ||
| 140 | 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 |
| 141 | EUCTR2015-000392-28-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 142 | EUCTR2015-000392-28-GR (EUCTR) | 18/11/2015 | 22/10/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Ellas SA | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 143 | 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 |
| 144 | EUCTR2015-000392-28-DE (EUCTR) | 11/11/2015 | 25/08/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 145 | EUCTR2015-000392-28-GB (EUCTR) | 10/11/2015 | 01/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 146 | EUCTR2015-000392-28-NL (EUCTR) | 02/11/2015 | 24/08/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 147 | EUCTR2015-000424-28-DE (EUCTR) | 02/11/2015 | 27/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 148 | 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 |
| 149 | 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 | ||
| 150 | EUCTR2015-000424-28-LT (EUCTR) | 14/10/2015 | 29/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 151 | EUCTR2015-000424-28-HU (EUCTR) | 22/09/2015 | 11/08/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED | Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 152 | EUCTR2015-000392-28-DK (EUCTR) | 22/09/2015 | 22/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 153 | EUCTR2015-001617-27-IT (EUCTR) | 18/09/2015 | 17/06/2015 | A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC | A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC | Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys. MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: IVA337 Product Code: IVA337 INN or Proposed INN: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID | Inventiva SAS | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 154 | 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 | ||
| 155 | EUCTR2014-005323-27-GB (EUCTR) | 16/09/2015 | 29/09/2015 | A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosis | A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial - The Abatacept Systemic SclErosis Trial (ASSET) | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 18.0;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 18.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: Abatacept Other descriptive name: Orencia | University of Michigan | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Italy;United Kingdom | ||
| 156 | EUCTR2015-000424-28-DK (EUCTR) | 10/09/2015 | 17/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 157 | 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 | ||
| 158 | EUCTR2015-000424-28-IT (EUCTR) | 07/09/2015 | 30/09/2021 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO ASSESS 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. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | France;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 | ||
| 159 | EUCTR2015-000424-28-BE (EUCTR) | 07/09/2015 | 28/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 160 | NCT02551042 (ClinicalTrials.gov) | September 2015 | 17/12/2014 | CSL Behring Sclero XIII | A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chloride | University College, London | CSL Behring | Recruiting | 18 Years | N/A | Both | 26 | Phase 2 | United Kingdom |
| 161 | EUCTR2015-000424-28-ES (EUCTR) | 07/08/2015 | 04/08/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 162 | 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 |
| 163 | EUCTR2015-000424-28-PT (EUCTR) | 31/07/2015 | 30/07/2015 | A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis. | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 164 | 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 |
| 165 | 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 |
| 166 | EUCTR2014-001353-16-GB (EUCTR) | 17/04/2015 | 03/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 m | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan | ||
| 167 | EUCTR2014-001101-40-GB (EUCTR) | 24/02/2015 | 14/01/2015 | Investigation of safety and therapeutic effect of Fibrogammin® in Scleroderma | Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII | Systemic Sclerosis MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Fibrogammin® 1250 Product Name: Fibrogammin® 1250 INN or Proposed INN: blood coagulation factor XIII | University College London (UCL) | NULL | Not Recruiting | Female: yes Male: yes | 26 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 168 | EUCTR2014-001353-16-DE (EUCTR) | 19/02/2015 | 16/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan | ||
| 169 | 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 |
| 170 | EUCTR2014-001353-16-CZ (EUCTR) | 22/01/2015 | 06/11/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 AG | NULL | Not 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): no | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 171 | EUCTR2014-001353-16-IT (EUCTR) | 19/01/2015 | 14/05/2015 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 AG | NULL | Not 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): no | United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 172 | 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 |
| 173 | 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 |
| 174 | EUCTR2014-001353-16-NL (EUCTR) | 31/12/2014 | 20/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 AG | NULL | Not 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): no | United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 175 | EUCTR2014-001353-16-HU (EUCTR) | 30/12/2014 | 14/11/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 AG | NULL | Not 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): no | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 176 | EUCTR2014-001353-16-ES (EUCTR) | 22/12/2014 | 03/11/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 177 | EUCTR2014-001353-16-BE (EUCTR) | 09/12/2014 | 21/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 AG | NULL | Not 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): no | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 178 | 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 |
| 179 | EUCTR2014-000865-34-DE (EUCTR) | 31/10/2014 | 10/09/2014 | A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis | A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis | Raynaud's Phenomenon secondary to Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom | ||
| 180 | 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 |
| 181 | NCT02260557 (ClinicalTrials.gov) | October 2014 | 6/10/2014 | Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis | Raynaud's Phenomenon Secondary to Systemic Sclerosis | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 74 | Phase 2 | France;Germany;United Kingdom |
| 182 | EUCTR2014-000865-34-GB (EUCTR) | 16/09/2014 | 10/09/2014 | A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis | A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis | Raynaud's Phenomenon secondary to Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom | ||
| 183 | 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 |
| 184 | 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 |
| 185 | EUCTR2013-003200-39-GB (EUCTR) | 01/04/2014 | 04/04/2014 | Investigation of Zibotentan for kidney disease in scleroderma | A phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA) | Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease). MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857 MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Zibotentan Product Code: ZD4054 INN or Proposed INN: Zibotentan | University College London | NULL | Not Recruiting | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 186 | EUCTR2010-022710-77-CZ (EUCTR) | 06/01/2014 | 02/02/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | |||
| 187 | EUCTR2012-004955-35-IT (EUCTR) | 29/07/2013 | 30/05/2013 | A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy” | A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy” | SYSTEMIC SCLEROSIS MedDRA version: 16.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Mabthera | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 188 | 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 |
| 189 | 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 |
| 190 | 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 |
| 191 | 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 |
| 192 | EUCTR2012-001369-34-IT (EUCTR) | 12/02/2013 | 21/12/2012 | Proof of biological activity of SAR100842 in Systemic Sclerosis | Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: SAR100842 Product Name: NA Product Code: SAR100842 | SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT | NULL | Not Recruiting | Female: yes Male: yes | 30 | United States;Canada;Germany;United Kingdom;Switzerland;Italy | |||
| 193 | 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 |
| 194 | NCT01651143 (ClinicalTrials.gov) | January 2013 | 24/7/2012 | Proof of Biological Activity of SAR100842 in Systemic Sclerosis | Double-blind, Randomized, Placebo-controlled, 8-week Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis | Drug: SAR100842;Drug: Placebo | Sanofi | NULL | Completed | 18 Years | N/A | Both | 30 | Phase 2 | United States;France;Italy;Switzerland;United Kingdom;Germany |
| 195 | EUCTR2012-001369-34-DE (EUCTR) | 19/11/2012 | 17/08/2012 | Proof of biological activity of SAR100842 in Systemic Sclerosis | Initial title : Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic SclerosisRevised title according to the protocol amendment 4 :Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: SAR100842 Product Code: SAR100842 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 30 | United States;Canada;Germany;United Kingdom;Switzerland | |||
| 196 | EUCTR2012-001369-34-GB (EUCTR) | 26/10/2012 | 15/06/2012 | Proof of biological activity of SAR100842 in Systemic Sclerosis | Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Code: SAR100842 Product Code: SAR100842 | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;Italy;Switzerland;United Kingdom | ||
| 197 | 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 |
| 198 | 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;Drug: Mycophenolate Mofetil;Other: Placebo Infusion | Hospital for Special Surgery, New York | Human Genome Sciences Inc. | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 199 | 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 | ||
| 200 | EUCTR2010-022710-77-PL (EUCTR) | 30/05/2012 | 12/03/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | |||
| 201 | EUCTR2010-022969-95-PL (EUCTR) | 30/05/2012 | 12/03/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand | |||
| 202 | EUCTR2010-022710-77-IT (EUCTR) | 11/04/2012 | 09/02/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis) | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA | ACTELION PHARMACEUTICALS LTD. | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 203 | EUCTR2010-022969-95-GR (EUCTR) | 02/04/2012 | 28/03/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | |||
| 204 | 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 | ||
| 205 | 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 | ||
| 206 | 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 | ||
| 207 | 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 | ||
| 208 | NCT01553981 (ClinicalTrials.gov) | March 2012 | 11/3/2012 | A Trial of Tadalafil in Interstitial Lung Disease of Scleroderma | A Double Blind Randomized Control Trial of Tadalafil in Interstitial Lung Disease of Scleroderma | Lung Diseases, Interstitial | Drug: Tadalafil;Drug: Placebo | Sanjay Gandhi Postgraduate Institute of Medical Sciences | NULL | Completed | 18 Years | 70 Years | Both | 40 | Phase 3 | India |
| 209 | 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 |
| 210 | EUCTR2010-022969-95-NL (EUCTR) | 27/02/2012 | 12/12/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand | |||
| 211 | EUCTR2010-022969-95-PT (EUCTR) | 03/02/2012 | 12/12/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand | |||
| 212 | EUCTR2011-001460-22-GB (EUCTR) | 19/01/2012 | 17/10/2011 | A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are. | A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A | Systemic Sclerosis (SSc) MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS) Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Germany;United Kingdom | ||
| 213 | EUCTR2010-022969-95-BE (EUCTR) | 16/01/2012 | 29/11/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 3 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | ||
| 214 | EUCTR2010-022710-77-FI (EUCTR) | 10/01/2012 | 07/12/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 215 | EUCTR2010-022969-95-GB (EUCTR) | 21/12/2011 | 27/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Phase 3 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand | ||
| 216 | EUCTR2010-022969-95-IE (EUCTR) | 07/12/2011 | 31/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | |||
| 217 | 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 |
| 218 | 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 |
| 219 | 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 |
| 220 | EUCTR2011-001460-22-DE (EUCTR) | 28/11/2011 | 20/10/2011 | A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are. | A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A | Systemic Sclerosis (SSc) MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: RoActemra Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS) Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 2/3 | France;United States;Canada;Germany;United Kingdom | ||
| 221 | EUCTR2010-022710-77-BG (EUCTR) | 17/11/2011 | 26/08/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | |||
| 222 | EUCTR2010-022969-95-DE (EUCTR) | 09/08/2011 | 31/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | |||
| 223 | 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 |
| 224 | EUCTR2010-022710-77-DE (EUCTR) | 16/06/2011 | 31/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 225 | EUCTR2010-022969-95-ES (EUCTR) | 26/05/2011 | 18/11/2011 | A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma). | Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis. | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand | |||
| 226 | NCT01257802 (ClinicalTrials.gov) | May 2011 | 9/12/2010 | GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases | GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases | Lupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial Diffuse | Drug: depot leuprolide acetate 3.75 mg;Drug: Placebo | Joseph Mccune | National Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Terminated | 18 Years | 40 Years | Female | 14 | Phase 3 | United States |
| 227 | NCT01347008 (ClinicalTrials.gov) | April 2011 | 2/5/2011 | Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis | Effect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial | Scleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud Phenomenon | Drug: Sildenafil citrate;Drug: Placebo (Sugar pill) | Federal University of São Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 18 Years | N/A | Female | 41 | Phase 3 | Brazil |
| 228 | EUCTR2010-022710-77-DK (EUCTR) | 22/03/2011 | 03/02/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 229 | 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 | ||||
| 230 | NCT01315899 (ClinicalTrials.gov) | March 2011 | 14/3/2011 | Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon | Phase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis | Raynaud's Phenomenon | Drug: ORM-12471 30mg;Drug: ORM-12471;Drug: placebo | Orion Corporation, Orion Pharma | NULL | Terminated | 18 Years | 75 Years | Both | 15 | Phase 2 | United Kingdom |
| 231 | EUCTR2010-022710-77-HU (EUCTR) | 28/02/2011 | 01/02/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | |||
| 232 | NCT01295736 (ClinicalTrials.gov) | November 2010 | 11/2/2011 | Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY | Evaluation of the Efficacy of Sildenafil on Time to Healing in Patients With Scleroderma and Ischaemic Digital Ulcers: a Prospective, Longitudinal, Randomized, Comparative, Double-blind, 2-parallel-arm, Placebo-controlled Study | Systemic Scleroderma | Drug: Sildenafil;Drug: placebo | University Hospital, Lille | NULL | Completed | 18 Years | N/A | Both | 84 | Phase 3 | France |
| 233 | NCT00946699 (ClinicalTrials.gov) | March 2010 | 23/7/2009 | A Study of the Safety and Tolerability of MEDI-551 in Scleroderma | A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma | Scleroderma | Biological: MEDI-551;Biological: Placebo;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 50 | Phase 1 | United States;Canada;United Kingdom |
| 234 | NCT01117298 (ClinicalTrials.gov) | November 2009 | 3/5/2010 | A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma | A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study | Raynaud's Phenomenon;Digital Ulcers;Scleroderma | Drug: Tadalafil;Drug: Placebo | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Institute of Postgraduate Medical Education and Research;Postgraduate Institute of Medical Education and Research;Army Research and Referral hospital | Completed | 18 Years | 65 Years | Both | 66 | Phase 3 | India |
| 235 | 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 |
| 236 | EUCTR2007-002015-38-IT (EUCTR) | 05/06/2009 | 19/06/2009 | Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND | Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND | Skin Fibrosis in patients with systemic sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 | ISDIN S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy | ||
| 237 | 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 |
| 238 | EUCTR2007-003621-24-AT (EUCTR) | 30/03/2009 | 23/04/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 239 | EUCTR2008-005018-39-GB (EUCTR) | 05/03/2009 | 22/05/2009 | DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 | DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1 | Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma | Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15C-SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | United Kingdom | |||
| 240 | EUCTR2007-003621-24-GB (EUCTR) | 02/12/2008 | 14/07/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 241 | 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 |
| 242 | 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 |
| 243 | 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 |
| 244 | EUCTR2007-003621-24-NL (EUCTR) | 23/07/2008 | 13/03/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 245 | EUCTR2007-003621-24-IT (EUCTR) | 15/07/2008 | 17/11/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil | MONDOGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 246 | EUCTR2007-003621-24-BE (EUCTR) | 20/06/2008 | 08/01/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 247 | EUCTR2007-003621-24-FR (EUCTR) | 29/05/2008 | 27/12/2007 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 248 | EUCTR2007-003122-24-GB (EUCTR) | 09/04/2008 | 15/02/2008 | A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis | A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis | Diffuse Cutaneous Systemic Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis MedDRA version: 9.1;Classification code 10036814;Term: Progressive systemic sclerosis MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma MedDRA version: 9.1;Classification code 10012941;Term: Diffuse scleroderma MedDRA version: 9.1;Classification code 10018124;Term: Generalized scleroderma MedDRA version: 9.1;Classification code 10042954;Term: Systemic sclerosis pulmonary | Product Name: AIMSPRO | Daval International Limited | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 249 | NCT01545427 (ClinicalTrials.gov) | April 2008 | 1/3/2012 | Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma | A Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma | Scleroderma | Drug: Imatinib mesylate;Other: Placebo | Lawson Health Research Institute | Novartis Pharmaceuticals | Terminated | 18 Years | N/A | Both | 10 | Phase 2 | Canada |
| 250 | EUCTR2007-003621-24-DE (EUCTR) | 20/03/2008 | 13/02/2009 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 251 | EUCTR2007-002015-38-DE (EUCTR) | 20/12/2007 | 03/08/2007 | PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. | PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. | SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 252 | EUCTR2007-002015-38-GB (EUCTR) | 19/12/2007 | 31/07/2007 | PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. | PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. | SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 DIGNA CREAM Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Spain;Germany;Italy;United Kingdom | ||
| 253 | NCT00479934 (ClinicalTrials.gov) | December 2007 | 29/5/2007 | Efficacy and Safety of Imatinib in Scleroderma | Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement. | Scleroderma, Localized;Scleroderma, Systemic | Drug: imatinib mesylate | University Hospital, Bordeaux | Ministry of Health, France;Novartis | Completed | 18 Years | N/A | Both | 28 | Phase 2 | France |
| 254 | NCT00577304 (ClinicalTrials.gov) | December 2007 | 18/12/2007 | A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon | A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon | Raynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Other Autoimmune Disease | Drug: Nitroglycerin;Drug: Topical AmphiMatrix | MediQuest Therapeutics | NULL | Active, not recruiting | 15 Years | 70 Years | Both | 200 | Phase 3 | United States |
| 255 | NCT00581997 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis | A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis | Pulmonary Fibrosis Secondary to Systemic Sclerosis | Drug: QAX576;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | Both | 8 | Phase 2 | United States |
| 256 | EUCTR2007-002015-38-HU (EUCTR) | 04/09/2007 | 09/07/2007 | Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. | Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. | SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Other descriptive name: DIGNA P144 CREAM | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy | ||
| 257 | NCT00574613 (ClinicalTrials.gov) | September 2007 | 13/12/2007 | Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic Sclerosis | Phase II, Multicenter, Randomized, Double-blind, Intraindividually Placebo Controlled Clinical Trial, to Evaluate Efficacy and Safety of p144 Topical Administration for Skin Fibrosis in Patients With Systemic Sclerosis | Skin Fibrosis | Drug: P144;Drug: placebo | ISDIN | Digna Biotech S.L. | Completed | 18 Years | 65 Years | Both | 56 | Phase 2 | Germany;Hungary;Italy;Poland;Spain;United Kingdom |
| 258 | 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 | ||
| 259 | NCT00419419 (ClinicalTrials.gov) | December 2006 | 4/1/2007 | Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon | Phase III In-Life Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon | Raynaud's Disease;Scleroderma;Autoimmune Diseases | Drug: Topical AmphiMatrix with nitroglycerin (MQX-503) | MediQuest Therapeutics | NULL | Completed | 18 Years | 70 Years | Both | 80 | Phase 3 | United States;Sweden;United Kingdom |
| 260 | EUCTR2005-004979-37-GB (EUCTR) | 27/11/2006 | 18/09/2006 | Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 | Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 | Moderate to severe primary Raynaud’s, OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma | Product Name: MQX-503 Product Code: MQX-503 INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP Other descriptive name: Nitroglycerine gel | MediQuest Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom;Sweden | ||
| 261 | EUCTR2005-004979-37-SE (EUCTR) | 27/10/2006 | 08/09/2006 | Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 | Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 | Moderate to severe primary Raynaud’s,OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as scleroderma | Product Name: MQX-503 Product Code: MQX-503 INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP Other descriptive name: Nitroglycerine gel | MediQuest Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Sweden | ||
| 262 | 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 |
| 263 | NCT00348296 (ClinicalTrials.gov) | July 2006 | 3/7/2006 | Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis | Scleroderma, Systemic | Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH) | Benesis Corporation | NULL | Completed | 16 Years | N/A | Both | 60 | Phase 3 | Japan |
| 264 | EUCTR2006-000905-41-AT (EUCTR) | 07/06/2006 | 08/05/2006 | Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud | Offene, monozentrische, randomisierte, placebo-kontrollierte, einfach blinde und Observer-blinde klinische Studie bei PatientInnen mit Raynaud Syndrom mit / ohne progressiver systemischer Sklerodermie zur systemischen Therapie mit Iloprost versus Placebo - iloprost in raynaud | Raynaud syndrome with / without systemic sclerosis | Trade Name: Ilomedin Product Name: Ilomedin Product Code: 1-22460 | ao. Univ. Prof. Dr. Elisabeth Aberer | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Austria | |||
| 265 | NCT00740285 (ClinicalTrials.gov) | April 2004 | 19/8/2008 | Effectiveness and Safety of Lidocaine for Scleroderma | Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial | Scleroderma | Drug: Lidocaine 2% without vessel constrictor;Other: Placebo - physiological solution 0,9% | Federal University of São Paulo | NULL | Completed | 18 Years | 60 Years | Both | 26 | Phase 2/Phase 3 | Brazil |
| 266 | NCT00077584 (ClinicalTrials.gov) | October 2003 | 10/2/2004 | Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis | Digital Ulcers;Systemic Sclerosis | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada |
| 267 | NCT02800993 (ClinicalTrials.gov) | October 2003 | 13/6/2016 | Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis | Systemic Sclerosis;Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada |
| 268 | NCT00070590 (ClinicalTrials.gov) | July 2003 | 6/10/2003 | Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis | Pulmonary Fibrosis;Scleroderma, Systemic | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom |
| 269 | NCT00043706 (ClinicalTrials.gov) | May 2002 | 12/8/2002 | Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis | A Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis | Systemic Sclerosis;Scleroderma | Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody | Genzyme, a Sanofi Company | Cambridge Antibody Technology | Completed | 18 Years | 75 Years | Both | Phase 1/Phase 2 | United States | |
| 270 | NCT00707187 (ClinicalTrials.gov) | July 2001 | 25/6/2008 | Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction | Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis | Systemic Sclerosis | Drug: Cialis | University of Medicine and Dentistry of New Jersey | NULL | Completed | 18 Years | N/A | Female | 120 | Phase 2 | United States |
| 271 | NCT00418132 (ClinicalTrials.gov) | August 2000 | 3/1/2007 | Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis | T Cell Immunity in Collagen Biosynthesis of Scleroderma | Scleroderma, Systemic | Drug: Thalidomide;Drug: Placebo thalidomide | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Terminated | 18 Years | 65 Years | Both | 30 | Phase 1 | United States |
| 272 | 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 |
| 273 | 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 |
| 274 | NCT00704665 (ClinicalTrials.gov) | December 1998 | 23/6/2008 | Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma | A Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse Scleroderma | Systemic Sclerosis | Drug: Relaxin | University of Medicine and Dentistry of New Jersey | University of California, Los Angeles;Boston University;University of Chicago;University of Connecticut Health Center;Johns Hopkins University;University of Pittsburgh;Medical University of South Carolina;Stanford University;Georgetown University;University of California, San Diego;Wayne State University;University of Colorado, Denver;Medical College of Wisconsin | Completed | 18 Years | 70 Years | Both | 231 | Phase 3 | NULL |
| 275 | NCT00004786 (ClinicalTrials.gov) | December 1995 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis | Systemic Sclerosis;Raynaud Disease | Drug: iloprost | National Center for Research Resources (NCRR) | University of Pittsburgh | Completed | 18 Years | N/A | Both | 200 | Phase 3 | NULL |