51. Scleroderma Clinical trials / Disease details
Clinical trials : 523 / Drugs : 608 - (DrugBank : 156) / Drug target genes : 114 - Drug target pathways : 215
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03800017 (ClinicalTrials.gov) | September 1, 2022 | 21/11/2018 | Skeletal Muscle Function in Interstitial Lung Disease | Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease | Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial Pneumonia | Biological: Hyperoxia | University of British Columbia | NULL | Not yet recruiting | 40 Years | 80 Years | All | 40 | N/A | NULL |
| 2 | NCT04356287 (ClinicalTrials.gov) | April 2022 | 15/4/2020 | Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis | Phase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic Sclerosis | Sclerosis, Systemic;Mesenchymal Stem Cells | Biological: UCMSC;Other: Placebo | Marie Hudson, MD | Assistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health Centre | Not yet recruiting | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | NULL |
| 3 | NCT05214014 (ClinicalTrials.gov) | March 1, 2022 | 29/11/2021 | Treatment of Systemic Sclerosis With Autologous Regulatory ?-cells | Treatment of Patients With Systemic Sclerosis With Autologous Regulatory ?-cells | Systemic Sclerosis | Biological: Autologous Regulatory ?-cells;Other: Standard treatment according to the clinical protocols | Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Belarusian State Medical University | Not yet recruiting | 18 Years | 80 Years | All | 30 | Phase 1/Phase 2 | NULL |
| 4 | NCT05236491 (ClinicalTrials.gov) | March 2022 | 10/2/2022 | COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases | COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases | Rheumatoid Arthritis;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Systemic Vasculitis;Systemic Sclerosis;Scleroderma;Undifferentiated Connective Tissue Diseases;Overlap Connective Tissue Disease;Immunosuppression | Biological: COVID-19 vaccine | Paul R Fortin | Canadian Institutes of Health Research (CIHR) | Not yet recruiting | 18 Years | N/A | All | 287 | Phase 2/Phase 3 | NULL |
| 5 | NCT05198557 (ClinicalTrials.gov) | March 2022 | 6/1/2022 | A Study of MT-0551 in Patients With Systemic Sclerosis | Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study) | Systemic Sclerosis | Drug: Inebilizumab;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Not yet recruiting | 20 Years | 80 Years | All | 80 | Phase 3 | Japan |
| 6 | JPRN-jRCT2031210521 | 15/02/2022 | 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 | Pending | >= 20age old | <= 80age old | Both | 80 | Phase 3 | Japan |
| 7 | NCT05214794 (ClinicalTrials.gov) | February 14, 2022 | 17/1/2022 | An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis | An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis | Systemic Sclerosis | Drug: nemolizumab | Maruho Co., Ltd. | NULL | Not yet recruiting | 20 Years | 70 Years | All | 8 | Phase 2 | Japan |
| 8 | NCT05016804 (ClinicalTrials.gov) | February 2022 | 17/8/2021 | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic Sclerosis | Systemic Sclerosis | Biological: AlloRx | The Foundation for Orthopaedics and Regenerative Medicine | NULL | Recruiting | N/A | N/A | All | 20 | Phase 1 | Antigua and Barbuda |
| 9 | 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 | ||
| 10 | 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 | United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of | ||
| 11 | 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 | ||
| 12 | NCT04789850 (ClinicalTrials.gov) | January 2022 | 10/2/2021 | Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis | Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial | Systemic Sclerosis | Drug: Itacitinib;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | N/A | All | 74 | Phase 2 | France |
| 13 | JPRN-jRCT2031210481 | 12/12/2021 | 12/12/2021 | An Open-label, Phase 2 Study to Assess the Effecacy and Safety of Nemolizumab in Subjects with Systemic Sclerosis | An Open-label, Phase 2 Study to Assess the Effecacy and Safety of Nemolizumab in Subjects with Systemic Sclerosis | Systemic Sclerosis | Nemolizumab will be administered subcutaneously | Nishiura Tomoyuki | NULL | Pending | >= 20age old | <= 70age old | Both | 8 | Phase 2 | Japan |
| 14 | NCT05029336 (ClinicalTrials.gov) | December 2021 | 24/8/2021 | Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases | Systemic Lupus Erythematosus;Systemic Sclerosis | Biological: Depletion of CD3/CD19 in an autologous stem cell transplant | Stephan Grupp MD PhD | NULL | Recruiting | 8 Years | 25 Years | All | 20 | Phase 2 | United States |
| 15 | NCT05098145 (ClinicalTrials.gov) | November 24, 2021 | 20/10/2021 | A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis | A Single-arm, Multi-center, Open-label Proof of Concept Safety and Efficacy Study of FCR001 Cell-based Therapy in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis at Risk for Organ Failure | Diffuse Cutaneous Systemic Sclerosis | Biological: FCR001 | Talaris Therapeutics Inc. | NULL | Recruiting | 18 Years | 70 Years | All | 18 | Phase 1/Phase 2 | United States |
| 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 | Recruiting | 18 Years | 80 Years | All | 25 | 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 | Recruiting | 18 Years | 75 Years | All | 48 | Phase 2 | United States;United Kingdom |
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | NCT04948554 (ClinicalTrials.gov) | September 16, 2021 | 4/6/2021 | Study of ACE-1334 to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease | A Phase 1b/2 Open-Label, Multiple-Ascending Dose Study Followed by a Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease | Systemic Sclerosis With and Without Interstitial Lung Disease | Drug: ACE-1334;Drug: Placebo | Acceleron Pharma Inc. | NULL | Recruiting | 18 Years | N/A | All | 210 | Phase 1/Phase 2 | United States |
| 21 | 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 Kingdom;Italy;Germany;Poland;Belgium;Spain;Canada;United States | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 |
| 28 | 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 | ||
| 29 | NCT04647890 (ClinicalTrials.gov) | July 19, 2021 | 16/11/2020 | Effects of FT011 in Systemic Sclerosis | A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis | Scleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, Systemic | Drug: FT011;Drug: Placebo | Certa Therapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Australia |
| 30 | NCT04627857 (ClinicalTrials.gov) | July 1, 2021 | 6/11/2020 | Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis | Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis | Scleroderma Systemic | Device: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss) | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 100 | N/A | France |
| 31 | NCT04837131 (ClinicalTrials.gov) | April 28, 2021 | 5/4/2021 | A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients | A Phase 2 Open-Label Pilot Study of the Safety and Tolerability of Ixazomib Administered Orally to Patients With Scleroderma-Related Interstitial Lung Disease | Systemic Sclerosis;Scleroderma;Diffuse Systemic Sclerosis;Diffuse Scleroderma;Diffuse Cutaneous Systemic Sclerosis;Diffuse Cutaneous Scleroderma;Progressive Systemic Sclerosis;Progressive Scleroderma;Scleroderma, Systemic;Scleroderma, Diffuse;Progressive;Systemic Sclerosis, Diffuse;Systemic; Sclerosis, Progressive;Scleroderma of Lung;Scleroderma With Pulmonary Involvement;Systemic Sclerosis Pulmonary;Systemic Sclerosis With Lung Involvement;Interstitial Lung Disease;Pulmonary Fibrosis Interstitial | Drug: Ixazomib | W. Leroy Griffing | NULL | Recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 32 | NCT04826419 (ClinicalTrials.gov) | April 1, 2021 | 29/3/2021 | Effect of Ozone Therapy for the Treatment of Digital Ulcer in Patients With SSc | Non-invazive Ozone Therapy and Digital Ulcer in Patients With SSc | Systemic Sclerosis | Other: ozone therapy | Pamukkale University | NULL | Completed | 18 Years | 75 Years | All | 25 | N/A | Turkey |
| 33 | NCT04781543 (ClinicalTrials.gov) | April 1, 2021 | 1/3/2021 | A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis;Sclerosis, Systemic | Drug: HZN-825 BID;Drug: Placebo;Drug: HZN-825 QD | Horizon Therapeutics Ireland DAC | NULL | Recruiting | 18 Years | 75 Years | All | 300 | Phase 2 | United States;Argentina;France;Greece;Korea, Republic of;Portugal |
| 34 | 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 | Recruiting | >= 18age old | <= 75age old | Both | 56 | Phase 2 | Japan |
| 35 | EUCTR2021-000880-63-SE (EUCTR) | 11/03/2021 | 23/02/2021 | COVID-19 vaccine in patients with rheumatic diseases: The impact of treatments on the vaccine response protection against infection (COVID19-REUMA) | COVID-19 vaccine in patients with inflammatory rheumatic diseases: The impact of immunomodulating treatments on the antibody response, T cells response and protection against infection (COVID19-REUMA) - COVID19-REUMA | rheumatoid arthritis, SLE, systemic vasculitis, systemic sclerosis, spondylarthritis;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Comirnaty Product Name: Comirnaty INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified) Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19) Trade Name: COVID-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) | Skåne University Hospital, department of rheumatology in Lud and Malmö | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 868 | Phase 4 | Sweden | ||
| 36 | ChiCTR2100042327 | 2021-03-01 | 2021-01-19 | Observation of curative effection of Milli Fire Needle in treating Localized Scleroderma | Feasibility and Safety of Milli Fire Needle in Localized Scleroderma Treatment | Localized Scleroderma | treatment group:Milli Fire Needle+0.1% tacrolimus oinment;control group:0.1% tacrolimus oinment; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | treatment group:45;control group:45; | China | |
| 37 | ChiCTR2100041982 | 2021-03-01 | 2021-01-10 | An Open-Label Clinical Study to Evaluate the 24-Week Efficacy and 52-Week Safety of Baricitinib in Patients with Early Diffuse Cutaneous Systemic Sclerosis | An Open-Label Clinical Study to Evaluate the 24-Week Efficacy and 52-Week Safety of Baricitinib in Patients with Early Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis | A:baricitinib 4mg;B:baricitinib2mg;C:no intervention; | Huashan Hospital, Fudan University | NULL | Recruiting | 18 | 70 | Both | A:25;B:50;C:50; | China | |
| 38 | NCT04683029 (ClinicalTrials.gov) | February 24, 2021 | 22/12/2020 | A Study of Guselkumab in Participants With Systemic Sclerosis | A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic Sclerosis | Scleroderma, Systemic | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Placebo | Janssen Pharmaceutical K.K. | NULL | Recruiting | 18 Years | 75 Years | All | 56 | Phase 2 | Japan |
| 39 | NCT04440592 (ClinicalTrials.gov) | February 5, 2021 | 17/6/2020 | Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis | Drug: MT-7117;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 18 Years | N/A | All | 72 | Phase 2 | United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom |
| 40 | 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 | ||
| 41 | 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 |
| 42 | NCT04680975 (ClinicalTrials.gov) | December 24, 2020 | 11/12/2020 | Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | Diffuse Cutaneous Systemic Sclerosis | Drug: Belumosudil | Kadmon Corporation, LLC | NULL | Active, not recruiting | 18 Years | N/A | All | 15 | Phase 2 | United States |
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | ||
| 46 | NCT04303208 (ClinicalTrials.gov) | December 2020 | 3/3/2020 | Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic Sclerosis | Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic Sclerosis | Systemic Sclerosis | Procedure: 2 ml of whole blood sample will be collected on EDTA tube | Assiut University | NULL | Not yet recruiting | 18 Years | N/A | All | 80 | N/A | NULL |
| 47 | 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 | ||
| 48 | EUCTR2019-004718-32-NL (EUCTR) | 09/10/2020 | 09/10/2020 | Stem cell transplantation in diffuse cutaneous systemic sclerosis: upfront therapy or rescue therapy after failure of immunosuppressants? | Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial | Diffuse cutaneous systemic sclerosis according to the ACR/EULAR criteria;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Mycophenolate mofetil | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 4 | Netherlands | ||
| 49 | 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 |
| 50 | 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 | ||
| 51 | EUCTR2019-003430-16-FR (EUCTR) | 28/07/2020 | 02/06/2020 | 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 - SCLERITA - SCLERITA | Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening 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: Itacitinib Product Code: INCB039110 INN or Proposed INN: ITACITINIB | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 2 | France | ||
| 52 | 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 | ||
| 53 | 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 |
| 54 | NCT04265144 (ClinicalTrials.gov) | June 8, 2020 | 5/2/2020 | Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre | Cohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune Diseases | Scleroderma;Systemic Sclerosis | Biological: Blood samples;Other: Biopsy;Other: Bronchoalveolar samples | University Hospital, Bordeaux | NULL | Recruiting | 18 Years | N/A | All | 500 | N/A | France |
| 55 | NCT04244916 (ClinicalTrials.gov) | May 25, 2020 | 6/1/2020 | MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic Sclerosis | Prospective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic Sclerosis | Systemic Sclerosis | Biological: AUC of MPA measure | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 50 | France | |
| 56 | 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 | ||
| 57 | 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 |
| 58 | NCT04523506 (ClinicalTrials.gov) | May 8, 2020 | 19/7/2020 | The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma | The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma | Scleroderma | Biological: Botulinum toxin(Botox) | University of Texas Southwestern Medical Center | NULL | Completed | 18 Years | 65 Years | All | 17 | Early Phase 1 | United States |
| 59 | ChiCTR2000031572 | 2020-05-01 | 2020-04-04 | A randomized controlled clinical study on the efficacy and safety of erbium laser percutaneous methotrexate in the treatment of localized scleroderma | A randomized controlled clinical study on the efficacy and safety of erbium laser percutaneous methotrexate in the treatment of localized scleroderma | morphea | control group:Erbium laser;experimental group:erbium laser assisted delivery of methotrexate; | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | NULL | Recruiting | 18 | 65 | Both | control group:28;experimental group:28; | China | |
| 60 | NCT04325217 (ClinicalTrials.gov) | April 15, 2020 | 26/3/2020 | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 61 | 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 | ||
| 62 | ChiCTR2000030370 | 2020-03-01 | 2020-02-29 | The efficacy and safety of sirolimus for the treatment of Systemic Sclerosis: a single-arm, single-center pilot study | The efficacy and safety of sirolimus for the treatment of Systemic Sclerosis: a single-arm, single-center pilot study | Systemic Sclerosis | treatment group:sirolimus; | The First Affiliated Hospital of China Medical University | NULL | Recruiting | 18 | Both | treatment group:20; | China | ||
| 63 | 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 | ||
| 64 | EUCTR2019-003906-28-FR (EUCTR) | 24/02/2020 | 18/11/2019 | Adipose tissu derived-stem cells injections from patients with sclerodermia to treat thier refractory digital ulcers. | Subcutaneous injections of autologous cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma : a phase II study - ADUSE | Patients with systemic sclerosis presenting digital ulcer : - located beyond the proximal interphalangeal joint, on finger surface (included periungueal ulcers), - of ischemic origin according to the physician, - not over subcutaneous calcifications or bone relief, - active DU - refractory after 10±2 weeks of standard of care (that is either still active or new occurrence despite standard of care);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: autologous ASC | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 65 | EUCTR2019-002444-24-GB (EUCTR) | 18/02/2020 | 18/12/2019 | Clinical trial of a single dose of treprostinil injected as a depot under the skin to investigate the effect on the digital blood flow and safety in patients with Raynaud’s Phenomenon due to Systemic Sclerosis | An Exploratory Trial Assessing Vascular Digital Perfusion, Pharmacokinetics, Safety and Tolerability Following a Single Dose of CAM2043 (Treprostinil Subcutaneous Depot) in Patients with Raynaud’s Phenomenon Secondary to Systemic Sclerosis | Raynaud’s phenomenon secondary to systemic sclerosis MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CAM2043 Product Code: CAM2043 INN or Proposed INN: Treprostinil Sodium Other descriptive name: TREPROSTINIL SODIUM | Camurus AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | United Kingdom | ||
| 66 | 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 | ||
| 67 | JPRN-jRCTs031180366 | 22/01/2020 | 18/03/2019 | The Effectiveness of Glycyrrhizin in Systemic Sclerosis | Exploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic Sclerosis | Systemic sclerosis | Treatment with Glycyrrhizin for systemic sclerosis | Sumida Hayakazu | NULL | Recruiting | >= 20age old | < 80age old | Both | 20 | N/A | Japan |
| 68 | NCT03582800 (ClinicalTrials.gov) | January 6, 2020 | 13/6/2018 | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | Systemic Sclerosis;Dermatomyositis;iPPSD2 | Drug: STS | University Hospital, Limoges | NULL | Recruiting | 6 Months | N/A | All | 40 | Phase 2 | France |
| 69 | NCT04656704 (ClinicalTrials.gov) | January 1, 2020 | 30/11/2020 | Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease | Investigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin Disease | Microstomia;Scleroderma;CREST Syndrome;Scleromyxedema;Morphea | Drug: hyaluronidase injected intradermally | Brigham and Women's Hospital | NULL | Withdrawn | 18 Years | N/A | All | 0 | Early Phase 1 | NULL |
| 70 | 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 |
| 71 | NCT03740724 (ClinicalTrials.gov) | December 18, 2019 | 6/11/2018 | A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) | A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) | Morphea;Scleroderma, Localized;Scleroderma | Genetic: FCX-013;Drug: veledimex | Castle Creek Biosciences, LLC. | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 72 | 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 | ||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 | ||
| 76 | 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 |
| 77 | EUCTR2019-001279-34-DE (EUCTR) | 30/09/2019 | 18/07/2019 | A clinical study to test long term safety of GLPG1690 for patients with systemic sclerosis | A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis | Systemic sclerosis 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 | ||
| 78 | NCT04137224 (ClinicalTrials.gov) | September 19, 2019 | 21/10/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) and IgPro10 (Intravenous Immunoglobulin, Privigen®) in Adults With Systemic Sclerosis (SSc) | Diffuse Cutaneous Systemic Sclerosis | Biological: IgPro20;Biological: IgPro10 | CSL Behring | NULL | Active, not recruiting | 18 Years | N/A | All | 27 | Phase 2 | Australia;Germany;Italy;Poland;United Kingdom;France |
| 79 | EUCTR2019-001279-34-IT (EUCTR) | 17/09/2019 | 15/01/2021 | A clinical study to test long term safety of GLPG1690 for patients with systemic sclerosis | A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis - - | Systemic sclerosis 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Belgium;Germany;United Kingdom;Italy | ||
| 80 | EUCTR2019-001279-34-GB (EUCTR) | 20/08/2019 | 24/05/2019 | A clinical study to test long term safety of GLPG1690 for patients with systemic sclerosis | A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis | Systemic sclerosis 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: ziritaxestat Other descriptive name: GLPG1690 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United States;Spain;Belgium;Germany;Italy;United Kingdom | ||
| 81 | EUCTR2019-001279-34-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A clinical study to test long term safety of GLPG1690 for patients with systemic sclerosis | A multicenter, open-label extension study to evaluate the long-term safety, tolerability and efficacy of orally administered GLPG1690 in subjects with systemic sclerosis | Systemic sclerosis 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;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 82 | EUCTR2018-001978-22-FR (EUCTR) | 31/07/2019 | 17/09/2018 | Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. | Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. - ITS Pilot | Patient presenting with: - ectopic ossification secondary to iPPSD2 or - ectopic calcification secondary to dermatomyositis or - ectopic calcification secondary to systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10006935;Term: Calcification and ossification, unspecified;System Organ Class: 100000004867 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Sodium Thiosulfate 10% Product Name: Sodium thiosulfate INN or Proposed INN: Sodium thiosulfate 10% Other descriptive name: SODIUM THIOSULFATE PENTAHYDRATE | CHU de LIMOGES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 83 | NCT04045743 (ClinicalTrials.gov) | July 19, 2019 | 27/7/2019 | The Benefit of Bermekimab in Patients With Systemic Sclerosis | Clinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial) | Scleroderma, Systemic | Drug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab) | Hellenic Institute for the Study of Sepsis | NULL | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | Greece |
| 84 | NCT03976648 (ClinicalTrials.gov) | July 18, 2019 | 4/6/2019 | A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis | A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis | Systemic Sclerosis | Drug: GLPG1690 | Galapagos NV | NULL | Terminated | 18 Years | N/A | All | 31 | Phase 2 | United States;Belgium;Italy;Spain;United Kingdom |
| 85 | 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 | ||
| 86 | EUCTR2018-003149-41-DE (EUCTR) | 16/07/2019 | 20/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with 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] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous 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 | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 87 | NCT03919799 (ClinicalTrials.gov) | July 9, 2019 | 21/11/2018 | KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis | A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic Sclerosis | System; Sclerosis;Diffuse Cutaneous Systemic Sclerosis | Drug: Belumosudil (KD025);Drug: Placebo | Kadmon Corporation, LLC | NULL | Active, not recruiting | 18 Years | 100 Years | All | 60 | Phase 2 | United States |
| 88 | EUCTR2018-004655-20-GR (EUCTR) | 30/05/2019 | 31/01/2019 | 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) - LIGHT | CLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL) MedDRA version: 20.0;Level: PT;Classification code 10078638;Term: Systemic scleroderma;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: BERMEKIMAB INN or Proposed INN: N/A Other descriptive name: BERMEKIMAB | HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Greece | ||
| 89 | EUCTR2018-003149-41-FR (EUCTR) | 24/05/2019 | 27/03/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | 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 | France;Poland;Australia;Germany;Italy;United Kingdom | ||
| 90 | EUCTR2018-003149-41-IT (EUCTR) | 23/05/2019 | 22/01/2021 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - NA | Safety and Pharmacokinetics in subjects with diffuse cutaneous systemicsclerosis 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] | Trade Name: Hizentra Product Name: Immunoglobulina Normale Umana per somministrazione sottocutanea Product Code: [IgPro20] INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE Trade Name: Privigen Product Name: immunoglobulina Normale Umana per somministrazione endovenosa Product Code: [IgPro10] INN or Proposed INN: immunoglobulina normale umana | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;United Kingdom;Italy | ||
| 91 | 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 |
| 92 | 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 |
| 93 | EUCTR2018-003149-41-GB (EUCTR) | 15/05/2019 | 30/07/2019 | Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc). | A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - n/a | Safety and Pharmacokinetics in subjects with 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] | Trade Name: Hizentra Product Name: Human normal immunoglobulin for subcutaneous administration Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Trade Name: Privigen Product Name: Human normal immunoglobulin for intravenous administration Product Code: IgPro10 INN or Proposed INN: Human normal immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;Poland;Australia;Germany;Italy;United Kingdom | ||
| 94 | 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 | ||
| 95 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 312 | Phase 1 | United States;Canada |
| 96 | 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 | ||
| 97 | 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 | ||
| 98 | 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 |
| 99 | 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 | ||
| 100 | 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 |
| 101 | JPRN-jRCTc071190041 | 04/01/2019 | 09/01/2020 | A clinical trial of autologous stem cell transplantation for severe systemic sclerosis | A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis | systemic sclerosis | After peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted. | Akashi Koichi | NULL | Recruiting | >= 16age old | < 65age old | Both | 12 | Phase 2 | Japan |
| 102 | NCT03831438 (ClinicalTrials.gov) | January 1, 2019 | 31/1/2019 | Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis | A Phase 1 Open-Label Study to Determine the Safety and Tolerability of AVID200: A Transforming Growth Factor ß (TGFß) Inhibitor, in Patients With Diffuse Cutaneous Systemic Sclerosis | Scleroderma, Diffuse | Drug: AVID200 | Formation Biologics | NULL | Active, not recruiting | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 103 | 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 |
| 104 | EUCTR2018-001719-65-NL (EUCTR) | 10/12/2018 | 09/07/2018 | CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study | CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study | Systemic sclerosis (SSc) is a rare progressive autoimmune disease hallmarked by severe vasculopathy. Patients are prone to enhanced calcification of skin and the vasculature. Active calcifications may not only occur in the skin of patients with clinically overt calcinosis cutis, but also in SSc patients without. Since calcification is strongly associated with local inflammation, it may very well occur in internal organs and serve as an early proxy for long-term SSc-related complications.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Sodium fluoride 18F Product Code: EMA/CHMP/212874/2015 | University Medial Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 105 | NCT03742466 (ClinicalTrials.gov) | November 10, 2018 | 10/11/2018 | Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients | Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical Trial | Carpal Tunnel Syndrome;Chronic Pain;Scleroderma | Drug: Ozone;Drug: methylprednisolone acetate | Assiut University | NULL | Completed | 20 Years | 60 Years | All | 50 | N/A | Egypt |
| 106 | NCT03675581 (ClinicalTrials.gov) | November 8, 2018 | 17/9/2018 | A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) | A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) | Scleroderma, Systemic | Drug: Microgynon;Drug: Nintedanib | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | Female | 17 | Phase 1 | Belgium;France;Germany;Netherlands;Portugal;Spain |
| 107 | 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 |
| 108 | EUCTR2016-003403-66-SE (EUCTR) | 15/10/2018 | 14/05/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;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;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 109 | EUCTR2016-003403-66-IT (EUCTR) | 28/09/2018 | 14/06/2021 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS(TM)- ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;Classification code 10012977;Term: Diffuse 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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;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 | ||
| 110 | 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 | ||
| 111 | 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 | ||
| 112 | EUCTR2016-003403-66-GR (EUCTR) | 21/09/2018 | 14/05/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 113 | NCT03575156 (ClinicalTrials.gov) | September 20, 2018 | 7/6/2018 | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis | Systemic Lupus Erythematosus;Systemic Scleroderma | Biological: blood sample;Biological: urine sample | University Hospital, Bordeaux | NULL | Active, not recruiting | 18 Years | N/A | All | 208 | N/A | France |
| 114 | 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 | ||
| 115 | NCT03678987 (ClinicalTrials.gov) | September 13, 2018 | 13/9/2018 | Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis | Mycophenolate Mofetil in Systemic Sclerosis: A Phase 1 Pharmacokinetic Study of Orally Ingested Mycophenolate Mofetil Tablets in Patients Suffering From Systemic Sclerosis | Systemic Sclerosis;Gastrointestinal Complication | Diagnostic Test: P-MPA concentration;Drug: mycophenolic acid | Region Skane | NULL | Completed | 18 Years | N/A | All | 35 | Phase 1 | Sweden |
| 116 | NCT03629002 (ClinicalTrials.gov) | September 2018 | 7/8/2018 | BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA | BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND | Systemic Scleroderma | Biological: Study of the gene expression profile | Assistance Publique Hopitaux De Marseille | NULL | Unknown status | 18 Years | N/A | All | 30 | France | |
| 117 | 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 |
| 118 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation | Paul Szabolcs | NULL | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States |
| 119 | EUCTR2016-003403-66-FI (EUCTR) | 17/07/2018 | 29/06/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R) -ON | Systemic Sclerosis 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] - Respiratory Tract Diseases [C08] | 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 Fnland Ky | NULL | Not Recruiting | Female: yes Male: yes | 400 | 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 | ||
| 120 | 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 | ||
| 121 | EUCTR2016-003403-66-CZ (EUCTR) | 20/06/2018 | 12/04/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 122 | NCT03365869 (ClinicalTrials.gov) | June 1, 2018 | 4/12/2017 | A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis | A Phase ? Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Sirolimus | Peking University People's Hospital | NULL | Not yet recruiting | 18 Years | 80 Years | All | 72 | Phase 2 | NULL |
| 123 | NCT03593902 (ClinicalTrials.gov) | May 17, 2018 | 28/6/2018 | Cardiac Safe Transplants for Systemic Sclerosis | Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction | Systemic Sclerosis;Scleroderma | Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 2/Phase 3 | United States |
| 124 | NCT03607071 (ClinicalTrials.gov) | May 15, 2018 | 20/7/2018 | Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma | Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study | Myocardial Inflammation | Drug: Prednisolone and taper | Khon Kaen University | NULL | Completed | 18 Years | N/A | All | 20 | Phase 2 | Thailand |
| 125 | NCT03508375 (ClinicalTrials.gov) | May 15, 2018 | 16/4/2018 | Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis | Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis | Systemic Scleroderma | Biological: blood samples | Assistance Publique Hopitaux De Marseille | NULL | Recruiting | 18 Years | N/A | All | 75 | N/A | France |
| 126 | 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 | ||
| 127 | EUCTR2016-003403-66-AT (EUCTR) | 17/04/2018 | 28/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;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;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 128 | EUCTR2016-003403-66-BE (EUCTR) | 12/04/2018 | 12/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM) Extension | Systemic Sclerosis 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] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | 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 | ||
| 129 | EUCTR2016-003403-66-DK (EUCTR) | 05/04/2018 | 02/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-on | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;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 | ||
| 130 | EUCTR2016-003403-66-FR (EUCTR) | 04/04/2018 | 01/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON | Systemic Sclerosis 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] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | 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 | ||
| 131 | 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 | ||
| 132 | 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 | ||
| 133 | EUCTR2016-003403-66-PT (EUCTR) | 23/02/2018 | 13/12/2017 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Norway;Japan;Sweden;United States;Portugal;Greece;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;Poland;Brazil;Belgium;Germany | ||
| 134 | EUCTR2016-003403-66-GB (EUCTR) | 07/02/2018 | 09/01/2018 | A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | 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;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 135 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 136 | EUCTR2016-003403-66-ES (EUCTR) | 19/01/2018 | 22/11/2017 | A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON | Systemic Sclerosis 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] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | 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 | ||
| 137 | NCT03444220 (ClinicalTrials.gov) | January 18, 2018 | 13/2/2018 | Gut Microbiota Transplantation in Systemic Sclerosis | Reduce Disease Activity in Systemic Sclerosis by Transplantation of an Anaerobically Cultivated Human Intestinal Microbiota, a Controlled Interventional Pilot Trial | Scleroderma, Systemic | Biological: Anaerobically Cultivated Human Intestinal Microbiota;Biological: Anaerobically Cultivated medium | Oslo University Hospital | NULL | Completed | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | Norway |
| 138 | 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 |
| 139 | NCT03313180 (ClinicalTrials.gov) | November 27, 2017 | 13/10/2017 | A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis | An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD) | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Active, not recruiting | 18 Years | N/A | All | 444 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;India;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom;Ireland |
| 140 | JPRN-JapicCTI-173760 | 10/11/2017 | 07/11/2017 | Tocilizumab LTE study in patients with SSc | A PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic sclerosis | Intervention name : tocilizumab INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg/week, SC Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | CHUGAI PHARMACEUTICAL CO., LTD | NULL | complete | 18 | BOTH | 18 | Phase 3 | Japan | |
| 141 | EUCTR2016-003403-66-NL (EUCTR) | 06/11/2017 | 27/09/2017 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;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: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 142 | NCT04368403 (ClinicalTrials.gov) | October 6, 2017 | 13/4/2020 | A Study of KHK4827 in Patients With Systemic Sclerosis | A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis | Systemic Sclerosis | Drug: KHK4827 | Kyowa Kirin Co., Ltd. | NULL | Active, not recruiting | 18 Years | 70 Years | All | 8 | Phase 1 | Japan |
| 143 | JPRN-JapicCTI-173686 | 06/10/2017 | 29/08/2017 | A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis | A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis | systemic sclerosis | Intervention name : KHK4827 INN of the intervention : brodalumab Dosage And administration of the intervention : SC, 210 mg Q2W Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd. | NULL | complete | 18 | 70 | BOTH | 6 | Phase 1 | Japan |
| 144 | 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 | ||
| 145 | EUCTR2016-002651-25-GB (EUCTR) | 11/07/2017 | 08/05/2018 | A Study of Prednisolone in Patients with Early (within 3 years of onset) Diffuse Cutaneous Scleroderma (Systemic Sclerosis) | A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis - PRedSS: Prednisolone in Early Diffuse Systemic Sclerosis. Version 1.0 | Early diffuse cutaneous systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Prednisolone 5mg Gastro-resistant Tablets Product Name: Prednisolone 5mg Gastro-resistant Tablets INN or Proposed INN: Prednisolone Other descriptive name: Prednisolon;Prednisolona; Prednisoloni; Prednisolonum; Prednizolon;Prednizolonas | Research Governance and Integrity, University of Manchester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United Kingdom | ||
| 146 | 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 | ||
| 147 | 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 | ||
| 148 | 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 |
| 149 | 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 | ||
| 150 | NCT04822038 (ClinicalTrials.gov) | June 1, 2017 | 12/2/2021 | Immunomodulating Effects of Supplementation With 25-OH Vitamin D | Immunomodulating Effects of Supplementation With 25 oh Vitamin D in Adults With Scleroderma and Hypovitaminosis D | Vitamin D Deficiency;Scleroderma, Systemic | Dietary Supplement: Vitamin D3;Other: Dietary recommendations | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | N/A | All | 49 | N/A | Mexico |
| 151 | NCT03155464 (ClinicalTrials.gov) | June 1, 2017 | 24/4/2017 | Intraoperative ICG for Systemic Sclerosis | A Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic Scerlosis | Systemic Sclerosis | Procedure: Order of two elements of surgical procedure;Drug: Indocyanine Green | Duke University | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | NULL |
| 152 | EUCTR2015-001617-27-SI (EUCTR) | 26/05/2017 | 15/05/2017 | A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving. | A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC | Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs. MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: IVA337 Product Code: IVA337 INN or Proposed INN: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID | Inventiva SA | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland | ||
| 153 | 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 | ||
| 154 | 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 | ||
| 155 | 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 |
| 156 | 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 | ||
| 157 | EUCTR2016-002984-32-IT (EUCTR) | 16/02/2017 | 05/02/2018 | ND | Treatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - ND | SISTEMIC SCLEROSIS MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST INN or Proposed INN: ILOPROST TROMETAMOL Other descriptive name: ILOPROST SALE DI TROMETAMOLO Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST Product Code: ND INN or Proposed INN: ILOPROST TROMETAMOL Other descriptive name: ILOPROST SALE DI TROMETAMOLO | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 238 | Phase 4 | Italy | ||
| 158 | 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 | ||
| 159 | 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 | ||
| 160 | NCT02866552 (ClinicalTrials.gov) | January 2017 | 5/8/2016 | SCLERoderma et Adipose-DErived Stroma Cells | Systemic Sclerosis | Drug: Stromal Vascular fraction;Drug: Ringer lactate | Assistance Publique Hopitaux De Marseille | NULL | Not yet recruiting | 18 Years | N/A | Both | 44 | Phase 2 | France | |
| 161 | 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 |
| 162 | NCT02682511 (ClinicalTrials.gov) | January 2017 | 8/2/2016 | Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension | A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH) | Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune Diseases | Drug: Oral Ifetroban;Drug: Oral Placebo | Cumberland Pharmaceuticals | NULL | Recruiting | 18 Years | 80 Years | All | 34 | Phase 2 | United States;India |
| 163 | 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 |
| 164 | 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 | ||
| 165 | NCT03007004 (ClinicalTrials.gov) | December 12, 2016 | 28/12/2016 | Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis | Trial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis | Systemic Sclerosis Patients With Digital Ulcers | Drug: Botulinum toxin type B (2500 units / vial);Drug: Physiological saline | Gunma University | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | Japan |
| 166 | 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 |
| 167 | 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 |
| 168 | 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 | ||
| 169 | 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 | ||
| 170 | 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 | ||
| 171 | 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 | ||
| 172 | 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 | ||
| 173 | 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 |
| 174 | NCT02798055 (ClinicalTrials.gov) | September 30, 2016 | 3/6/2016 | Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis | A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment. | Systematic Sclerosis;Digital Ulcer;Scleroderma | Drug: Bosentan group | Elpen Pharmaceutical Co. Inc. | NULL | Completed | 18 Years | 80 Years | All | 148 | Greece | |
| 175 | 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 | ||
| 176 | 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 | ||
| 177 | 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 | ||
| 178 | 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 | ||
| 179 | 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 | ||
| 180 | 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 | ||
| 181 | 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 | ||
| 182 | EUCTR2015-005100-28-IT (EUCTR) | 18/07/2016 | 17/01/2022 | A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in patients with cutaneous lesions in scleroderma diseases. | A phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous lesions in scleroderma diseases. - A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in p | Fibrotic and atrophic cutaneous lesions in localized scleroderma diseases. MedDRA version: 20.0;Level: HLT;Classification code 10039711;Term: Scleroderma and associated disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: PLACENTEX ¿5.625 mg/3 ml soluzione iniettabile¿ Product Name: PLACENTEX ¿ Polydeoxyribonucleotide 5.625 mg/3 ml INN or Proposed INN: POLYDEOXYRIBONUCLEOTIDES Other descriptive name: PLACENTEX ® Polydeoxyribonucleotide | MASTELLI SRL | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 4 | Italy | ||
| 183 | EUCTR2015-000168-32-NL (EUCTR) | 13/07/2016 | 09/07/2015 | Mesenchymal stem cells as treatment for non healing wounds on the fingers in patients with systemic sclerosis | Mesenchymal stem cells for Angiogenesis and Neovascularization in digital Ulcers of Systemic sclerosis - MANUS Trial | 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] - Immune System Diseases [C20] | Product Name: Mesenchymal stem cells Product Code: MSC INN or Proposed INN: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS Other descriptive name: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 184 | 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 | ||
| 185 | 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 | ||
| 186 | 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 | ||
| 187 | JPRN-UMIN000022624 | 2016/07/01 | 06/06/2016 | Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD | Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD | The patients with systemic sclerosis or sclerodermatous chronic GVHD. | treatment with tocilizumab duration: 116 weeks dosage: 8mg/kg times: 6 times Frequency: every 4 weeks | Kanazawa University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 5 | Not selected | Japan |
| 188 | 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 | ||
| 189 | 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 | ||
| 190 | NCT02733978 (ClinicalTrials.gov) | June 2016 | 25/3/2016 | Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis | Non-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic Sclerosis | Ulcer;Scleroderma | Device: the ozone generator device (Human Pro medic, German) | Assiut University | NULL | Completed | N/A | N/A | All | 50 | N/A | NULL |
| 191 | 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 | |||
| 192 | EUCTR2014-002796-28-NL (EUCTR) | 12/04/2016 | 23/04/2015 | Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? | The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS | Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | University Medical Center Groningen (UMCG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 193 | 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 | ||
| 194 | NCT02680717 (ClinicalTrials.gov) | March 2016 | 9/2/2016 | Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea | Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea | Scleroderma | Drug: Clobetasol;Drug: Calcipotriene;Drug: Tacrolimus | Medical College of Wisconsin | Mayo Clinic;Seattle Children's Hospital;University of Toronto | Withdrawn | 2 Years | 18 Years | All | 0 | Phase 1 | NULL |
| 195 | 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 |
| 196 | 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 | ||
| 197 | 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 | ||
| 198 | 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 |
| 199 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;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;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 200 | 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 | ||
| 201 | 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 | ||
| 202 | 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 | ||
| 203 | 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 | ||
| 204 | 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 |
| 205 | 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 | ||
| 206 | 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 | ||
| 207 | 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 |
| 208 | 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 | ||
| 209 | 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 | ||
| 210 | 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 | ||
| 211 | 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 | ||
| 212 | 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 |
| 213 | 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 | ||
| 214 | 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 | ||
| 215 | JPRN-UMIN000020389 | 2015/10/01 | 06/01/2016 | Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD | Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD | The patients with systemic sclerosis or sclerodermatous chronic GVHD. | treatment with tocilizumab duration: 20 weeks dosage: 8mg/kg times: 6 times Frequency: every 4 weeks | Kanazawa University Hospital, Department of dermatology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 5 | Not selected | Japan |
| 216 | 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 | ||
| 217 | 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 | ||
| 218 | 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 | ||
| 219 | 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 | ||
| 220 | 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 | ||
| 221 | 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 | Japan;Germany;Bulgaria;Romania;Croatia;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;United Kingdom;Lithuania;Netherlands;South Africa;Denmark;France;Italy;Switzerland;Ireland;Spain;Greece;Portugal;United States | ||
| 222 | 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 | ||
| 223 | 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 | ||
| 224 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 225 | NCT02558543 (ClinicalTrials.gov) | September 2015 | 31/8/2015 | Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis | Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy Assessment | Scleroderma, Systemic | Drug: Stromal Vascular fraction;Drug: Ringer lactate | Assistance Publique Hopitaux De Marseille | NULL | Terminated | 18 Years | N/A | All | 40 | Phase 2 | France |
| 226 | 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 | ||
| 227 | 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 |
| 228 | 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 | ||
| 229 | JPRN-UMIN000018376 | 2015/07/22 | 22/07/2015 | Efficacy and safety of rituximab for patients with severe rheumatic disease | Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease | Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome) | 1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months | Yokohama City University Hospital Department of Pediatrics | NULL | Complete: follow-up complete | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 230 | 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 |
| 231 | NCT02371005 (ClinicalTrials.gov) | June 2015 | 18/2/2015 | Oral Manifestations of Systemic Sclerosis | Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers | Scleroderma, Systemic | Radiation: Cone Beam Computed Tomography (CBCT) | University Hospital, Strasbourg, France | NULL | Terminated | 18 Years | N/A | All | 85 | N/A | France |
| 232 | NCT03692299 (ClinicalTrials.gov) | June 2015 | 20/12/2016 | Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis | Efectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémica | Systemic Sclerosis;Small Intestinal Bacterial Overgrowth | Drug: Saccharomyces Boulardii Oral Tablet;Drug: Metronidazole | Coordinación de Investigación en Salud, Mexico | NULL | Completed | 18 Years | 65 Years | All | 39 | Phase 4 | Mexico |
| 233 | 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 |
| 234 | 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 | ||
| 235 | NCT02411643 (ClinicalTrials.gov) | March 2015 | 3/3/2015 | Molecular Effects of Topical Calcipotriene on Morphea | Molecular Effects of Topical Calcipotriene on Morphea | Morphea;Localized Scleroderma | Drug: topical calcipotriene 0.005% ointment | Northwestern University | NULL | Terminated | 18 Years | N/A | All | 2 | N/A | United States |
| 236 | 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 | ||
| 237 | 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 | ||
| 238 | 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 | ||
| 239 | 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 | ||
| 240 | 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 |
| 241 | NCT02642146 (ClinicalTrials.gov) | January 2015 | 24/12/2015 | Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study | Raynaud Disease;Systemic Sclerosis;Digital Ulcer | Drug: Calcium Channel Blockers;Drug: Phosphodiesterase Inhibitors;Drug: Endothelin receptor blocker;Drug: Prostanoids;Drug: Other vasodilator | Seoul National University Hospital | NULL | Terminated | 18 Years | N/A | All | 71 | Korea, Republic of | ||
| 242 | 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 | ||
| 243 | 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 | ||
| 244 | 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 | ||
| 245 | 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 | ||
| 246 | NCT02363478 (ClinicalTrials.gov) | December 2014 | 29/1/2015 | Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc) | Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc) | Systemic Sclerosis | Drug: buspirone | Laikon General District Hospital, Athens | NULL | Completed | 18 Years | 75 Years | All | 22 | Early Phase 1 | Greece |
| 247 | JPRN-UMIN000017617 | 2014/11/01 | 19/05/2015 | Effect of botulinum toxin A on Raynaud's phenomenon in patients with systemic sclerosis | Raynaud's phenomenon | Botulinum toxin A injection | Gunma University Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 248 | NCT02374320 (ClinicalTrials.gov) | November 2014 | 23/2/2015 | Exparel as a Nerve Block for Severe Hand Pain | Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine | CREST Syndrome;Peripheral Vascular Disease;Raynaud Disease;Scleroderma, Diffuse | Drug: liposomal bupivacaine | Jose Soberon, MD | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 2/Phase 3 | United States |
| 249 | 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 |
| 250 | 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 | ||
| 251 | EUCTR2014-001882-28-DE (EUCTR) | 13/10/2014 | 07/08/2014 | Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertension | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA | Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Volibris Product Name: Ambrisentan | Thoraxklinik-Heidelberg gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | ||
| 252 | 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 |
| 253 | 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 | ||
| 254 | NCT02166229 (ClinicalTrials.gov) | June 2014 | 10/6/2014 | Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma | Scleroderma;Systemic Sclerosis | Drug: Divalproex sodium | Yale University | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States | |
| 255 | NCT02213705 (ClinicalTrials.gov) | May 6, 2014 | 17/7/2014 | Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells | Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells | SYSTEMIC SCLERODERMA;ALLOGENEIC MESENCHYMAL STEM CELLS;ADULT | Biological: INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS | Assistance Publique - Hôpitaux de Paris | NULL | Active, not recruiting | 18 Years | 70 Years | All | 20 | Phase 1/Phase 2 | France |
| 256 | NCT02212249 (ClinicalTrials.gov) | May 2014 | 23/4/2014 | Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis | Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis | Primary Raynaud Disease;Systemic Sclerosis | Biological: soluble Ve cadherin | University Hospital, Grenoble | NULL | Completed | 18 Years | N/A | Both | 85 | N/A | France |
| 257 | JPRN-UMIN000015495 | 2014/04/01 | 22/10/2014 | Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) | Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) | Systemic sclerosis | Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies | Osaka University | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 5 | Not applicable | Japan |
| 258 | 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 | ||
| 259 | EUCTR2013-004596-12-IT (EUCTR) | 22/01/2014 | 13/12/2013 | Infusion at home ,using a pump device, of a drug that dilates peripheral blood vessels to treat patients affected by a disease named Systemic sclerosis, with manifestations caused by a reduced blood flow in hands and feet. | HOME INFUSION THERAPY WITH ILOPROST USING A PORTABLE SYRINGE PUMP FOR THE TREATMENT OF PERIPHERAL ULCERS AND RAYNAUD'S PHENOMENON IN SYSTEMIC SCLEROSIS. - iloporta | Raynaud's phenomenon and acral ulcers in systemic sclerosis;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Endoprost Product Name: Endoprost | Azienda ospedaliera universitaria Ospedali Riuniti | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 260 | 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 | Germany;Bulgaria;Denmark;Australia;Croatia;Poland;Canada;Czech Republic;Hungary;France;India;United Kingdom;Italy;Colombia;Chile;Russian Federation;Ukraine;Finland;Belarus | |||
| 261 | JPRN-UMIN000012214 | 2013/11/05 | 05/11/2013 | Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis | Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis | Systemic sclerosis | Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies Continue existing conventional therapies | The University of Tokyo | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 5 | Not applicable | Japan |
| 262 | EUCTR2012-003633-42-GB (EUCTR) | 18/10/2013 | 22/08/2013 | A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases | A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD | A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide | Royal Brompton and Harefield NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 263 | EUCTR2013-001353-28-IT (EUCTR) | 04/10/2013 | 04/07/2013 | An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis-Related Interstitial Lung Disease | An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis-Related Interstitial Lung Disease - LOTUSS | Systemic Sclerosis-Related Interstitial Lung Disease;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Esbriet INN or Proposed INN: PIRFENIDONE | InterMune Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Canada;Italy | ||
| 264 | NCT01933334 (ClinicalTrials.gov) | October 2013 | 23/8/2013 | Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) | The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) | Systemic Sclerosis | Drug: Pirfenidone | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 63 | Phase 2 | United States;Canada;Italy |
| 265 | 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 | ||||
| 266 | JPRN-JapicCTI-132176 | 01/6/2013 | Bosentan DU | A prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc) | Digital ulcers associated with systemic sclerosis | Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : Bosentan Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5. Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | BOTH | 20 | Phase 3 | NULL | |||
| 267 | 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 |
| 268 | NCT03561233 (ClinicalTrials.gov) | May 2013 | 7/6/2018 | Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis | Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis | Systemic Sclerosis;Gastroesophageal Reflux;Proton Pubm Inhibitor | Drug: Omeprazole 20mg | Khon Kaen University | Thai Rheumatism Association | Completed | 18 Years | N/A | All | 250 | Phase 1 | NULL |
| 269 | 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 |
| 270 | 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 |
| 271 | NCT02002897 (ClinicalTrials.gov) | April 2013 | 5/9/2013 | Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized Scleroderma | Fractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative Study | Localized Scleroderma | Device: Fractional carbon dioxide laser;Device: Ultraviolet A1 phototherapy (UVA1) | Cairo University | NULL | Recruiting | N/A | N/A | Both | 20 | N/A | Egypt |
| 272 | EUCTR2012-005348-92-IT (EUCTR) | 19/02/2013 | 11/01/2013 | PROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis | PROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis - PROGASS | Sysemic sclerosis with gastroenteric involvement (constipation) MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: RESOLOR*28CPR RIV 2MG INN or Proposed INN: PRUCALOPRIDE SUCCINATE | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | Italy | ||||
| 273 | 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 | |||
| 274 | 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 |
| 275 | 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 | |||
| 276 | 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 | ||
| 277 | NCT01895244 (ClinicalTrials.gov) | September 2012 | 1/7/2013 | Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis | Highdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation | Scleroderma;Cardiac Involvement;Autologous Stem Cell Transplantation | Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells | University Hospital Tuebingen | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Germany |
| 278 | NCT02169752 (ClinicalTrials.gov) | September 2012 | 6/5/2014 | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Pre-Pulmonary Atrial Hypertension | Drug: Ambrisentan | National Jewish Health | NULL | Terminated | 18 Years | 80 Years | All | 7 | N/A | United States |
| 279 | 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 |
| 280 | 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 | ||
| 281 | 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 | |||
| 282 | 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 | |||
| 283 | JPRN-UMIN000007702 | 2012/04/26 | 24/04/2012 | Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis | Interstitial lung disease secondary to systemic sclerosis | Rituximab(+) 30weeks 375mg/m2 once a week 4 times | Department of Dermatology, University of Tokyo | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 20 | Not selected | Japan | |
| 284 | 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 | |||
| 285 | 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 | |||
| 286 | EUCTR2011-002434-40-DE (EUCTR) | 23/03/2012 | 18/08/2011 | Transplantation of stem cells for the treatment of svere systemic sclerosis with a protocol which is adapted to individual manifestatons of the disease | Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosisModification according to manifestation - AST-MOMA | Systemic sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10059040;Term: Autologous peripheral haematopoietic stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CD34 selected autologous hematopoietic cells Product Code: CD34+SC | University Hospital Tuebingen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 287 | 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 | ||
| 288 | 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 | ||
| 289 | 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 | ||
| 290 | EUCTR2011-005303-32-NL (EUCTR) | 05/03/2012 | 26/01/2012 | The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II) | Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II) - HOME II | Digital Ulcera in Systemic Sclerodermia patients MedDRA version: 14.1;Level: PT;Classification code 10053400;Term: Endothelin increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Nederland bv | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 291 | 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 | ||
| 292 | 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 |
| 293 | 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 |
| 294 | 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 | |||
| 295 | 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;New Zealand;Netherlands;Germany;South Africa;Poland;Belgium;Argentina;Puerto Rico;Mexico;United Kingdom;Colombia;Russian Federation;Turkey;Ireland;Ukraine | |||
| 296 | NCT01554540 (ClinicalTrials.gov) | February 2012 | 7/2/2012 | Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study | Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers | Scleroderma, Systemic | Drug: Cutaneous iontophoresis of treprostinil | University Hospital, Grenoble | NULL | Active, not recruiting | 18 Years | N/A | Both | 40 | Phase 1/Phase 2 | France |
| 297 | NCT01497743 (ClinicalTrials.gov) | February 2012 | 20/12/2011 | Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis | Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis | Scleroderma | Drug: Lactobacillus | University of Michigan | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | United States |
| 298 | 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 | ||
| 299 | 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 | ||
| 300 | 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 | |||
| 301 | 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 | ||
| 302 | 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 | |||
| 303 | 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 |
| 304 | NCT01487551 (ClinicalTrials.gov) | December 2011 | 6/12/2011 | An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod) | An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod) | Systemic Sclerosis | Drug: paquinimod | Active Biotech AB | NULL | Completed | 18 Years | N/A | Both | 9 | Phase 2 | Germany;Sweden;Switzerland |
| 305 | 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 |
| 306 | 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 | ||
| 307 | 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 | |||
| 308 | NCT02240888 (ClinicalTrials.gov) | October 2011 | 4/9/2014 | Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response | RA;SLE;Vasculitis;Scleroderma;Sjögrens;Syndrome | Biological: 0,5 mg Prevenar i.m.;Biological: 0,5 mg seasonal influenza vaccine i.m. | Region Skane | NULL | Completed | 18 Years | N/A | All | 300 | N/A | Sweden | |
| 309 | EUCTR2011-001667-44-DE (EUCTR) | 28/09/2011 | 26/09/2011 | A study to evaluate biomarkers and safety in scleroderma patients treated with ABR-215757 (paquinimod) | An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod) | Systemic Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: paquinimod Product Code: ABR-215757 INN or Proposed INN: paquinimod | Active Biotech AB | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Switzerland;Sweden | |||
| 310 | NCT01445821 (ClinicalTrials.gov) | September 15, 2011 | 29/9/2011 | Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial | Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb) | Scleroderma, Systemic | Biological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Fludarabine | Northwestern University | NULL | Terminated | 17 Years | 60 Years | All | 44 | Phase 3 | United States |
| 311 | 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 | |||
| 312 | EUCTR2011-001667-44-SE (EUCTR) | 28/06/2011 | 18/05/2011 | An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod) | An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod) | Systemic Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: paquinimod Product Code: ABR-215757 INN or Proposed INN: paquinimod | Active Biotech AB | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Switzerland;Sweden | |||
| 313 | 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 | |||
| 314 | 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 | |||
| 315 | NCT01639573 (ClinicalTrials.gov) | April 2011 | 18/6/2012 | Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic Sclerosis | Campath-1h as Immunoablative Therapy for Children and Adolescents With Treatment Refractory Systemic Sclerosis | Scleroderma | Drug: Campath | Children's Hospital Los Angeles | NULL | Withdrawn | 8 Years | 18 Years | All | 0 | Phase 1/2 | United States |
| 316 | 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 | |||
| 317 | 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 | ||||
| 318 | 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 |
| 319 | NCT01395732 (ClinicalTrials.gov) | March 2011 | 6/7/2011 | Bosentan in Systemic Sclerosis | Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands | Systemic Sclerosis;Digital Ulcers | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 4 | Netherlands |
| 320 | 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 | |||
| 321 | NCT01284322 (ClinicalTrials.gov) | January 2011 | 25/1/2011 | Fresolimumab In Systemic Sclerosis | OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL | Diffuse Systemic Sclerosis | Drug: Fresolimumab | Boston University | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 1 | United States |
| 322 | EUCTR2010-019977-14-IT (EUCTR) | 04/11/2010 | 27/12/2010 | Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND | Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - ND | Patients affected by Systemic Sclerosis with Raynaud’s Phenomenon MedDRA version: 9.1;Level: LLT;Classification code 10042953 | Trade Name: PLETAL INN or Proposed INN: CILOSTAZOL | AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 323 | EUCTR2009-018194-31-GB (EUCTR) | 03/11/2010 | 18/03/2010 | Topical Amlodipine in Raynaud's Phenomenon | Topical Amlodipine in Raynaud's Phenomenon | The medical conditions under investigation in this trial are as follows:1] Primary Raynaud's Phenomenon2] Systemic Sclerosis (SSc) - otherwise known an Seconday Raynaud's Phenomenon.Raynaud's phenomenon is a disorder that affects the blood vessels in the fingers, toes, ears, and nose. This disorder is characterized by episodic attacks, called vasospastic attacks, that cause the blood vessels in the digits (fingers and toes) to constrict (narrow). | Product Name: Amlodipine Gel Product Code: AM-01 | Pharmarama International Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | United Kingdom | |||
| 324 | 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 |
| 325 | EUCTR2009-013468-37-GB (EUCTR) | 29/09/2010 | 17/03/2010 | A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon. - Asasantin retard therapy in the management of Raynaud's phenomenon | A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon. - Asasantin retard therapy in the management of Raynaud's phenomenon | Primary Raynaud's Phenomenon and Systemic Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10042953;Term: Systemic Sclerosis MedDRA version: 12.0;Classification code 10037917;Term: Raynaud's phenomenon | Trade Name: Asasantin Retard ® Product Name: ASASANTIN Retard INN or Proposed INN: aspirin INN or Proposed INN: dipyridamole | Royal National Hospital for Rheumatic Disease | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 326 | EUCTR2009-017869-27-DE (EUCTR) | 23/09/2010 | 14/07/2010 | A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis. | A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis. | Diffuse scleroderma MedDRA version: 12.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma | Product Name: Terguride Product Code: PR1 INN or Proposed INN: Terguride Other descriptive name: transdihydrolisuride | University Hospital Zurich | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 14 | Germany | |||
| 327 | EUCTR2010-021452-26-FR (EUCTR) | 20/09/2010 | 09/07/2010 | Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO | Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO | Les patients inclus dans l'étude seront des patients atteints de sclérodermie systémique (définie selon les critères de la classification de l'ACR et/ou de Leroy et Medsger) et présentant une crise rénale sclérodermique aigue définie par une HTA sévère d'emblée et/ou d'aggravation progressive >150/85mmHg obtenue à deux reprises minimum en 24H, sans autre explication que la ScS et/ou une insuffisance rénale rapidement progressive, sans autre explication que la ScS. MedDRA version: 8.1;Level: PT;Classification code 10062553;Term: scleroderma renal crisis | Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: bosentan Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: Bosentan | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 328 | JPRN-UMIN000031940 | 2010/09/07 | 28/03/2018 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis | Systemic sclerosis | Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells | Kyushu University | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | |
| 329 | JPRN-UMIN000004162 | 2010/09/01 | 05/09/2010 | The efficacy of Mizoribine for scleroderma of systemic sclerosis. | systemic sclerosis | a group of Mizoribine a group of the existing treatment | Faculty of Life Sciences, Kumamoto University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 330 | NCT02339441 (ClinicalTrials.gov) | June 2010 | 22/12/2014 | Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis | Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis | Early Diffuse Cutaneous Systemic Sclerosis | Drug: Methotrexate;Drug: Mycophenolate mofetil;Drug: Cyclophosphamide | University of Manchester | NULL | Completed | 18 Years | N/A | Both | 320 | N/A | NULL |
| 331 | EUCTR2008-001265-28-IT (EUCTR) | 02/03/2010 | 07/12/2009 | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - ND | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - ND | skin fibrosis of systemic sclerosis patients MedDRA version: 12.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144. Cytokines Inhibitors Product Code: P144 INN or Proposed INN: P144 Cytokines Inhibitors | ISDIN S.A. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 332 | 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 |
| 333 | NCT01374282 (ClinicalTrials.gov) | January 2010 | 14/6/2011 | Post Marketing Surveillance Study of Cuprimine | Post Marketing Surveillance Study of Cuprimine (MK-0172-001) | Scleroderma | Drug: Cuprimine (penicillamine) | Merck Sharp & Dohme Corp. | NULL | No longer available | N/A | N/A | Both | N/A | NULL | |
| 334 | NCT01586663 (ClinicalTrials.gov) | January 2010 | 25/4/2012 | Serial Night Time Position Splint on Systemic Sclerosis | Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis | Diffuse Systemic Sclerosis | Device: Serial night time position splint;Drug: Drug treatment | Federal University of São Paulo | NULL | Recruiting | 18 Years | N/A | Both | 76 | Phase 3 | Brazil |
| 335 | NCT01002508 (ClinicalTrials.gov) | November 2009 | 26/10/2009 | Influenza Vaccination in Patients With Scleroderma | Safety and Efficacy of Vaccination Against Influenza in Patients With Scleroderma | Influenza Vaccine in Scleroderma | Biological: Influenza vaccine | Tel-Aviv Sourasky Medical Center | NULL | Not yet recruiting | 16 Years | 90 Years | Both | 80 | Phase 4 | Israel |
| 336 | NCT00848107 (ClinicalTrials.gov) | September 2009 | 16/2/2009 | Open-Label Study of Oral Treprostinil in Digital Ulcers | Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension Study | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Terminated | 18 Years | N/A | All | 115 | Phase 2 | United States;Canada;United Kingdom |
| 337 | NCT00930683 (ClinicalTrials.gov) | September 2009 | 29/6/2009 | A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma | A Phase 1 Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor, in Adult Subjects With Scleroderma | Scleroderma | Drug: MEDI-546 | MedImmune LLC | NULL | Completed | 18 Years | N/A | Both | 34 | Phase 1 | United States |
| 338 | NCT00962923 (ClinicalTrials.gov) | August 2009 | 19/8/2009 | Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc) | Systemic Sclerosis;Mesenchymal Stem Cells | Biological: Allogeneic Mesenchymal Stem Cells (AlloMSC) | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | NULL | Recruiting | 15 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | China | |
| 339 | 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 | ||
| 340 | NCT00936546 (ClinicalTrials.gov) | June 2009 | 9/7/2009 | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis) | Drug: Rituximab | University Hospital, Ghent | NULL | Completed | 18 Years | N/A | All | 3 | Phase 2 | Belgium |
| 341 | EUCTR2008-007180-16-NL (EUCTR) | 13/05/2009 | 24/11/2008 | INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS) | INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS) | systemic sclerosis MedDRA version: 9.1;Level: PT;Classification code 10039710;Term: Scleroderma | Trade Name: Rituximab Product Name: Mabthera | LUMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 342 | 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 |
| 343 | 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 | |||
| 344 | 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 | |||
| 345 | EUCTR2008-006978-15-GB (EUCTR) | 05/03/2009 | 22/05/2009 | DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT | DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXT | Systemic Sclerosis, scleroderma digital ulcers MedDRA version: 14.0;Level: PT;Classification code 10039710;Term: Scleroderma;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | 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 Product Name: treprostinil diethanolamine Product Code: UT-15C SR INN or Proposed INN: treprostinil diethanolamine Product Name: treprostinil diethanolamine Product Code: UT-15 SR INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | United Kingdom;Canada;United States | |||
| 346 | NCT00764309 (ClinicalTrials.gov) | January 2009 | 1/10/2008 | Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis | An Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial Fibrosis | Scleroderma | Drug: dasatinib | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 47 | Phase 1/Phase 2 | United States |
| 347 | EUCTR2007-004669-17-IT (EUCTR) | 17/12/2008 | 16/06/2008 | A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis - ND | A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis - ND | sistemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10018124;Term: Generalized scleroderma | Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESILATO | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 27 | United Kingdom;Italy | |||
| 348 | 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 | ||
| 349 | NCT00848939 (ClinicalTrials.gov) | December 2008 | 19/2/2009 | Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis | An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: treprostinil diethanolamine | United Therapeutics | NULL | Completed | 18 Years | N/A | Both | 28 | Phase 1 | United States |
| 350 | 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 |
| 351 | EUCTR2008-001265-28-GB (EUCTR) | 14/11/2008 | 19/08/2008 | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - OLE | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - OLE | Skin fibrosis in patients with systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144. Cytokines Inhibitors INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 352 | EUCTR2006-004598-83-GB (EUCTR) | 22/10/2008 | 24/10/2008 | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | Severe systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Neupogen Product Name: Filgrastim INN or Proposed INN: FILGRASTIM Trade Name: Thymoglobuline Product Name: Thymoglobuline Product Code: rbATG INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS Trade Name: Solu-Medrone Product Name: Methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA | EBMT (European group for Blood and Marrow Transplantation) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | United Kingdom | |||
| 353 | EUCTR2008-000224-27-GB (EUCTR) | 15/10/2008 | 07/08/2008 | Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease | Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease | Systemic Sclerosis associated interstitial lung disease MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Solu-medrone Product Name: methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Product Name: cyclophosphamide Product Code: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE | Newcastle upon Tyne NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | United Kingdom | ||
| 354 | EUCTR2008-001265-28-DE (EUCTR) | 13/10/2008 | 19/05/2008 | OFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE | OFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE | Skin fibrosis in patients with systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Cytokine Inhibitor INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;Spain;Germany;Italy;United Kingdom | |||
| 355 | EUCTR2008-001265-28-HU (EUCTR) | 18/09/2008 | 05/08/2008 | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE | Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE | Skin fibrosis in patients with systemic sclerosis.Szisztémás szklerózisban szenvedo betegek. MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: P144 Product Code: P144 Cytokines Inhibitors INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Not Recruiting | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 356 | 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 |
| 357 | 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 | |||
| 358 | 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 | |||
| 359 | EUCTR2007-004669-17-DE (EUCTR) | 10/07/2008 | 13/03/2008 | A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis | A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis | systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Glivec 100 mg Filmtabletten Product Name: Glivec Product Code: STI571 INN or Proposed INN: imatinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 27 | Germany;Italy;United Kingdom | |||
| 360 | 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 | |||
| 361 | EUCTR2008-001265-28-ES (EUCTR) | 17/06/2008 | 08/04/2008 | Estudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE | Estudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE | 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. Cytokines Inhibitors INN or Proposed INN: P144 Other descriptive name: DIGNA P144 cream | ISDIN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | |||
| 362 | NCT00725361 (ClinicalTrials.gov) | June 2008 | 28/7/2008 | A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma). | A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis. | n Ulcer;Scleroderma, Systemic | Drug: Ambrisentan | Stanford University | NULL | Completed | 18 Years | N/A | All | 20 | N/A | United States |
| 363 | EUCTR2007-003621-24-FR (EUCTR) | 29/05/2008 | 27/12/2007 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 364 | 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 | ||
| 365 | 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 | |||
| 366 | EUCTR2007-004669-17-GB (EUCTR) | 15/02/2008 | 16/10/2007 | A multi-center, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis | A multi-center, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis | Skin fibrosis in systemic sclerosis patients MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Glivec Product Name: Glivec Product Code: STI571 INN or Proposed INN: imatinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 27 | United Kingdom;Italy | |||
| 367 | NCT00613171 (ClinicalTrials.gov) | January 2, 2008 | 25/1/2008 | Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis | A Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis | Systemic Sclerosis, Scleroderma | Drug: STI571 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 27 | Phase 2 | United States;Germany;Italy;Switzerland;United Kingdom |
| 368 | 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 | ||
| 369 | 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 | ||
| 370 | 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 |
| 371 | 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 |
| 372 | NCT00626665 (ClinicalTrials.gov) | December 2007 | 21/2/2008 | Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma | Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma | Raynaud Disease | Drug: Tadalafil | Sanjay Gandhi Postgraduate Institute of Medical Sciences | NULL | Completed | 18 Years | 70 Years | Both | 25 | Phase 3 | NULL |
| 373 | EUCTR2007-006035-32-IT (EUCTR) | 15/11/2007 | 15/01/2008 | Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND | Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - ND | Systemic Sclerosis and Hypercholesterolemia. MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: SINVACOR*28CPR RIV 20MG INN or Proposed INN: Simvastatin | AZIENDA OSPEDALIERA PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 374 | EUCTR2007-005322-68-IT (EUCTR) | 30/10/2007 | 04/10/2007 | Low-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in scleroderma | Low-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in scleroderma | Systemic Sclerosis MedDRA version: 6.1;Level: PT;Classification code 10042953 | Trade Name: GLIVEC INN or Proposed INN: Imatinib | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
| 375 | EUCTR2007-001508-19-IT (EUCTR) | 06/09/2007 | 29/07/2008 | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | GVH CRONICA ESTESA MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease | Trade Name: GLIVEC INN or Proposed INN: Imatinib | AZIENDA OSPEDALIERA S. CARLO | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 376 | 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 | ||
| 377 | EUCTR2006-007091-15-NL (EUCTR) | 03/09/2007 | 02/04/2007 | Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis | Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis | systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma | Product Name: Glivec | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Netherlands | |||
| 378 | 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 | ||
| 379 | NCT00684255 (ClinicalTrials.gov) | August 2007 | 22/5/2008 | Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc) | Reduced Intensity Conditioning And Allogeneic Stem Cell Transplantation in Patients With Medically Refractory Systemic Lupus Erythematosus and Medically Refractory Systemic Sclerosis (SSc) | Systemic Lupus Erythematosus;Systemic Sclerosis | Procedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: Campath | New York Medical College | NULL | Terminated | 7 Years | 50 Years | All | 1 | Phase 1 | United States |
| 380 | NCT00506831 (ClinicalTrials.gov) | July 2007 | 24/7/2007 | Imatinib in Systemic Sclerosis | A Pilot Study of Imatinib in the Treatment of Refractory Systemic Sclerosis | Scleroderma, Systemic | Drug: Imatinib mesylate | Stanford University | NULL | Completed | 18 Years | 80 Years | All | 9 | Phase 1/Phase 2 | United States |
| 381 | NCT00498615 (ClinicalTrials.gov) | April 2007 | 6/7/2007 | A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon | Efficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon | Raynaud;Scleroderma | Drug: Fasudil | Johns Hopkins University | NULL | Completed | 18 Years | 80 Years | All | 17 | Phase 3 | United States |
| 382 | NCT00463125 (ClinicalTrials.gov) | March 2007 | 19/4/2007 | Platelet Gel in Systemic Sclerosis | Platelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled Trial | Scleroderma, Systemic | Drug: Platelet Gel | Università Politecnica delle Marche | NULL | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 2/Phase 3 | Italy |
| 383 | JPRN-UMIN000000589 | 2007/02/01 | 14/02/2007 | Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis | systemic sclerosis (SSc) | Granulocyte-colony stimulating factor (G-CSF), "Gran" | Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine | NULL | Complete: follow-up complete | 18years-old | 70years-old | Male and Female | 8 | Phase 1,2 | Japan | |
| 384 | NCT00428883 (ClinicalTrials.gov) | January 2007 | 29/1/2007 | High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis | Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis | Scleroderma, Diffuse | Drug: N-acetylcysteine (NAC) | Università Politecnica delle Marche | NULL | Recruiting | 18 Years | 80 Years | Both | 45 | Phase 2/Phase 3 | Italy |
| 385 | 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 |
| 386 | 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 | ||
| 387 | NCT00379431 (ClinicalTrials.gov) | November 2006 | 20/9/2006 | A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab | A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab | Early and Severe Systemic Sclerosis | Drug: Administration of rituximab and methylprednisolone | University Hospital, Ghent | NULL | Active, not recruiting | 18 Years | N/A | Both | 40 | Phase 2 | Belgium |
| 388 | 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 | ||
| 389 | EUCTR2006-002081-19-NL (EUCTR) | 16/10/2006 | 21/07/2006 | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic SclerosisA phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic SclerosisA phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH | Pulmonary arterial hypertension associated with systemic sclerosis | Trade Name: Erbitux Product Name: Cetuximab Product Code: C225 | VU University Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 390 | EUCTR2006-003957-25-IT (EUCTR) | 13/10/2006 | 09/07/2007 | Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc | Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc | Systemic Scleroderma MedDRA version: 9.1;Level: LLT;Classification code 10055953;Term: Scleroedema | Trade Name: HIDONAC*EV 1FL 5G 25ML INN or Proposed INN: Acetylcysteine Trade Name: ENDOPROST 50*INFUS 1F 0,050MG/ INN or Proposed INN: Iloprost | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 391 | EUCTR2006-003836-31-BE (EUCTR) | 06/09/2006 | 02/08/2006 | A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab | A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab | systemic sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 392 | EUCTR2006-005230-20-IT (EUCTR) | 14/07/2006 | 12/07/2007 | EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS.Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica - ND | EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS.Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica - ND | Variazione della gravita' del fenomeno di Raynaud misurata mediante diario dei sintomi e scala analogica visiva VAS ? Visual Analogic Scale (6). Variazione dello stato globale di malattia valutata mediante HAQ ? Health Assessment Questionnaire (7). MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: CAPILLAREMA | OSPEDALE MAGGIORE DI MILANO (IRCCS) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 393 | 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 |
| 394 | NCT00378521 (ClinicalTrials.gov) | July 2006 | 18/9/2006 | Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon | Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon | Raynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Autoimmune Disease | Drug: MQX-503 | MediQuest Therapeutics | NULL | Completed | 18 Years | 75 Years | Both | 15 | Phase 2 | United States |
| 395 | 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 | |||
| 396 | NCT00318175 (ClinicalTrials.gov) | June 2006 | 24/4/2006 | Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis | Study to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF) | Systemic Scleroderma;Skin Fibrosis;Hand Functionality | Drug: Bosentan (Tracleer) | Heinrich-Heine University, Duesseldorf | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 2 | Germany |
| 397 | EUCTR2005-000701-61-GB (EUCTR) | 29/11/2005 | 27/10/2005 | An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 | An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 | Scleroderma renal crisis | Trade Name: Tracleer Product Name: Bosentan Product Code: N/A | University College London | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 398 | NCT00278525 (ClinicalTrials.gov) | September 2005 | 15/1/2006 | Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma | Trial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized Trial | SYSTEMIC SCLERODERMA | Drug: standard of care;Procedure: stem cell transplantation | Northwestern University | NULL | Completed | N/A | 60 Years | All | 19 | Phase 2 | United States |
| 399 | NCT00147771 (ClinicalTrials.gov) | September 2005 | 2/9/2005 | Imiquimod in Children With Plaque Morphea | Evaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot Study | Scleroderma, Localized | Drug: Imiquimod 5% cream | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 10 | Phase 3 | Canada |
| 400 | NCT00860548 (ClinicalTrials.gov) | June 2005 | 11/3/2009 | SCOT Scleroderma Treatment Alternative Registry (STAR Registry) | An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02) | Scleroderma, Systemic;Sclerosis | Drug: currently available therapy in the community | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 19 | N/A | United States |
| 401 | NCT00114530 (ClinicalTrials.gov) | June 2005 | 15/6/2005 | Scleroderma: Cyclophosphamide or Transplantation (SCOT) | A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01) | Scleroderma, Systemic;Sclerosis;Autoimmune Disease | Biological: mHSCT;Drug: cyclophosphamide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 75 | Phase 2/Phase 3 | United States;Canada |
| 402 | NCT00282425 (ClinicalTrials.gov) | May 2005 | 24/1/2006 | Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis | Scleroderma | Biological: Hematopoietic stem cell transplantation | Richard Burt, MD | NULL | Terminated | 18 Years | 55 Years | Both | 8 | Phase 1 | United States |
| 403 | EUCTR2004-000632-82-IT (EUCTR) | 06/04/2005 | 15/03/2007 | Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers | Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers | Healing and prevention of ischemic digital ulcers in patients with systemic sclerosis Level: PTClassification code 10059084 | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Italy | |||
| 404 | JPRN-UMIN000020701 | 2005/03/10 | 22/01/2016 | The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma | The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma - The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma | reflux esophagitis associated with systemic scleroderma | Rabeprazole sodium 1 tablet a day will be added to subjects whose symptom does not improve with 1 tablet a day. The study will continue until subjects meet discontinuance criteria. | Faculty of Medicine,Institute of Medical, Pharmaceutical and Health Sciences,Kanazawa University | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 40 | Not applicable | Japan |
| 405 | EUCTR2004-002712-28-IT (EUCTR) | 28/02/2005 | 15/02/2006 | Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study. | Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study. | Disease progression in scleroderma. MedDRA version: 6.1;Level: HLT;Classification code 10039711 | Trade Name: ENDOPROST 0,05MG/0,5ML 1F INN or Proposed INN: iloprost trometamol | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 3 | Italy | ||
| 406 | NCT00226889 (ClinicalTrials.gov) | January 2005 | 23/9/2005 | Treatment of Early Systemic Sclerosis by Bosentan | Systemic Sclerosis (Scleroderma) | Drug: bosentan | Rikshospitalet University Hospital | NULL | Terminated | 18 Years | 70 Years | Both | 30 | Phase 1/Phase 2 | Norway | |
| 407 | NCT00253331 (ClinicalTrials.gov) | November 2004 | 13/11/2005 | Lab Study of MQX-503 in Treatment of Raynaud's | Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon | Raynaud Disease;Raynaud Disease Secondary to Scleroderma;Raynaud Secondary to Other Autoimmune Disease | Drug: topical organogel with nitroglycerin | MediQuest Therapeutics | NULL | Completed | 18 Years | 80 Years | Both | 36 | Phase 2/Phase 3 | United States |
| 408 | EUCTR2004-000632-82-GB (EUCTR) | 16/09/2004 | 11/02/2005 | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Italy;United Kingdom | ||
| 409 | EUCTR2004-000631-28-IT (EUCTR) | 14/09/2004 | 17/09/2004 | Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. | Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. | Interstitial lung disease associated with systemic sclerosis | Trade Name: TRACLEER*125MG 56CPR RIV. Product Name: NA Product Code: NA INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 410 | NCT00319696 (ClinicalTrials.gov) | July 8, 2004 | 27/4/2006 | Bosentan in Digital Ulcers | Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers | Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg | Actelion | NULL | Completed | 18 Years | N/A | All | 116 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom |
| 411 | NCT00319033 (ClinicalTrials.gov) | July 2004 | 26/4/2006 | Open-label Study With Bosentan in Interstitial Lung Disease | Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330. | Interstitial Lung Disease;Scleroderma | Drug: bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;Canada;France;Germany;Israel;Italy;Korea, Republic of;Netherlands;Sweden;Switzerland;United Kingdom |
| 412 | 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 |
| 413 | NCT00624273 (ClinicalTrials.gov) | February 2004 | 14/2/2008 | Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis | Effect of Sildenafil on Digital Ulcers in Systemic Sclerosis | Active Digital Ulcers | Drug: Sildenafil therapy | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 80 Years | Both | 17 | Phase 2 | Germany |
| 414 | 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 |
| 415 | 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 |
| 416 | 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 |
| 417 | NCT00241189 (ClinicalTrials.gov) | August 2002 | 14/10/2005 | Rapamycin vs Methotrexate in Diffuse SSc | A 48-week, Double-blind, Randomized, Parallel Phase I/II Study of Oral Rapamycin Versus Methotrexate in Systemic Sclerosis (Scleroderma) | Systemic Sclerosis | Drug: rapamycin;Drug: methotrexate | University of California, Los Angeles | NULL | Completed | 18 Years | 70 Years | Both | 17 | Phase 1/Phase 2 | United States |
| 418 | 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 |
| 419 | NCT00025818 (ClinicalTrials.gov) | May 2001 | 26/10/2001 | Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome | Keratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, Systemic | Drug: Ophthalmic Emulsion | Allergan | NULL | Completed | 18 Years | N/A | Both | 290 | Phase 3 | United States | |
| 420 | NCT00501995 (ClinicalTrials.gov) | February 2001 | 13/7/2007 | High Dose Cyclophosphamide for Treatment of Scleroderma | High Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma) | Scleroderma | Drug: IV Cyclophosphamide | Johns Hopkins University | NULL | Completed | 18 Years | 70 Years | All | 6 | Phase 3 | United States |
| 421 | NCT00016458 (ClinicalTrials.gov) | June 2000 | 6/5/2001 | Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis | Systemic Sclerosis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide | Fred Hutchinson Cancer Research Center | NULL | Completed | N/A | 64 Years | Both | 20 | Phase 2 | United States | |
| 422 | 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 |
| 423 | 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 |
| 424 | 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 | |
| 425 | NCT00004380 (ClinicalTrials.gov) | December 1991 | 18/10/1999 | Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis | Systemic Sclerosis | Drug: relaxin | National Center for Research Resources (NCRR) | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Stanford University | Completed | N/A | N/A | Both | 1 | Phase 2 | NULL |