51. Systemic scleroderma
[
237 clinical trials,
287 drugs（DrugBank:
98 drugs),
89 target genes / 197 target pathways ]
Searched query = "Systemic scleroderma", "Systemic sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04138485 | November 2019 | 4 November 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 | Not recruiting | 18 Years | N/A | All | 144 | Phase 2 | ||
| 2 | NCT04040322 | October 14, 2019 | 28 October 2019 | Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis | 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. | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | United States | |
| 3 | NCT04095351 | October 1, 2019 | 30 September 2019 | Connective Tissue Diseases and Lung Manifestations | Connective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris) | Connective Tissue Diseases;Interstitial Lung Disease;Systemic Sclerosis | Diagnostic Test: Pulmonary function test;Diagnostic Test: Imaging;Biological: Blood sampling | Medical University Innsbruck | Boehringer Ingelheim | Not recruiting | 18 Years | 80 Years | All | 120 | N/A | |
| 4 | NCT04137224 | September 19, 2019 | 11 November 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 | Not recruiting | 18 Years | N/A | All | 26 | Phase 2 | Germany;Poland | |
| 5 | NCT03844061 | July 29, 2019 | 26 August 2019 | Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis | Drug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMF | Hospital for Special Surgery, New York | GlaxoSmithKline | Recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03976648 | July 18, 2019 | 4 November 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 | Sclerosis, Systemic | Drug: GLPG1690 | Galapagos NV | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States;Spain;United Kingdom | |
| 7 | NCT03919799 | July 9, 2019 | 30 September 2019 | 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 KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis | System; Sclerosis;Diffuse Cutaneous Systemic Sclerosis | Drug: KD025;Drug: Placebo | Kadmon Corporation, LLC | Recruiting | 18 Years | 100 Years | All | 60 | Phase 2 | United States | |
| 8 | JPRN-JapicCTI-194761 | 23/5/2019 | 7 October 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. | Recruiting | 18 | 70 | BOTH | 100 | Phase 3 | Japan | |
| 9 | NCT03957681 | May 23, 2019 | 16 September 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. | Recruiting | 18 Years | 70 Years | All | 100 | Phase 3 | Japan | |
| 10 | NCT03198689 | May 7, 2019 | 3 June 2019 | Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis | A Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma) | Diffuse Cutaneous Systemic Sclerosis | Drug: Brentuximab Vedotin | Lawson Health Research Institute | Seattle Genetics, Inc. | Recruiting | 18 Years | N/A | All | 10 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03816345 | April 4, 2019 | 11 November 2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States | |
| 12 | NCT03867097 | March 4, 2019 | 24 June 2019 | Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis | 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: Iloprost Injection, for intravenous use;Drug: Placebo IV infusion | Eicos Sciences, Inc. | Not recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States | |
| 13 | NCT03798366 | January 14, 2019 | 7 October 2019 | A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis | A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis | Scleroderma | Drug: GLPG1690;Drug: Placebo | Galapagos NV | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States;Belgium;Germany;Italy;Spain;United Kingdom | |
| 14 | NCT03831438 | January 1, 2019 | 9 September 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 | Recruiting | 18 Years | N/A | All | 24 | Phase 1 | United States | |
| 15 | NCT03817424 | December 13, 2018 | 30 September 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 | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | United States;Poland;Spain | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2018-001719-65-NL | 10/12/2018 | 28 February 2019 | 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 Pharmaceutical Form: Injection | University Medial Center Groningen | Authorised | Female: yes Male: yes | 120 | Phase 4 | Netherlands | |||
| 17 | NCT03675581 | November 8, 2018 | 4 November 2019 | 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 | Not recruiting | 18 Years | N/A | Female | 17 | Phase 1 | Belgium;France;Germany;Netherlands;Portugal;Spain | |
| 18 | NCT03211793 | November 2018 | 18 June 2018 | Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis | Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial | Systemic Sclerosis;Digital Ulcer | Drug: Mesenchymal stromal cells;Other: Placebo | UMC Utrecht | ZonMw: The Netherlands Organisation for Health Research and Development | Not recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | Netherlands |
| 19 | NCT03717961 | October 15, 2018 | 26 November 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 | Recruiting | 18 Years | N/A | All | 90 | Phase 3 | France | |
| 20 | NCT03575156 | September 20, 2018 | 9 October 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 | Recruiting | 18 Years | N/A | All | 200 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2016-003417-95-NL | 18/09/2018 | 1 October 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: GSK2330811 CAS Number: N/A Current Sponsor code: GSK2330811 Other descriptive name: GSK2330811 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 40 | Phase 2 | United States;Canada;Netherlands;United Kingdom | |||
| 22 | NCT03678987 | September 13, 2018 | 1 October 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 | Recruiting | 18 Years | N/A | All | 35 | N/A | Sweden | |
| 23 | NCT03593902 | September 7, 2018 | 26 August 2019 | 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 | Not recruiting | 18 Years | 65 Years | All | 50 | Phase 2/Phase 3 | United States | |
| 24 | NCT03629002 | September 2018 | 20 August 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 | Not recruiting | 18 Years | N/A | All | 30 | N/A | France | |
| 25 | NCT03558854 | August 28, 2018 | 11 November 2019 | 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 | Recruiting | 18 Years | 65 Years | All | 70 | Phase 4 | Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03630211 | July 31, 2018 | 15 April 2019 | 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 | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States | |
| 27 | JPRN-jRCTs031180366 | 21/06/2018 | 7 October 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 | Hayakazu Sumida | Recruiting | >= 20age old | < 80age old | Both | 20 | N/A | none | |
| 28 | NCT03856853 | June 15, 2018 | 11 March 2019 | Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease | A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) | Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild) | Drug: Pirfenidone;Other: placebo | Beijing Continent Pharmaceutical Co, Ltd. | Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group) | Recruiting | 18 Years | 75 Years | All | 144 | Phase 3 | China |
| 29 | NCT03365869 | June 1, 2018 | 16 December 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 | Not recruiting | 18 Years | 80 Years | All | 72 | Phase 2 | ||
| 30 | NCT03508375 | May 15, 2018 | 15 July 2019 | 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 | Recruiting | 18 Years | N/A | All | 75 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03607071 | May 15, 2018 | 26 August 2019 | 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 | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Thailand | |
| 32 | EUCTR2017-000372-29-ES | 25/04/2018 | 11 June 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 Pharmaceutical Form: Capsule INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-20 Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Lenabasum 20 mg Powder in Capsule Product Code: JBT-101 Pharmaceutical Form: Capsule INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-20 Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Corbus pharmaceuticals Inc. | Authorised | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of | |||
| 33 | JPRN-UMIN000031901 | 2018/04/01 | 2 April 2019 | Efficacy of acotiamide for scleroderma patients with esophageal symptoms | systemic sclerosis | proton pump inhibitor proton pump inhibitor and acotiamide | Juntendo University School of Medicine | Juntendo Tokyo Koto Geriatric Medical Center | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 34 | EUCTR2017-000372-29-DE | 07/03/2018 | 28 February 2019 | 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 Product Code: JBT-101 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENABASUM CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Lenabasum Product Code: JBT-101 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENABASUM CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Corbus pharmaceuticals Inc. | Authorised | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of | |||
| 35 | NCT03430388 | January 31, 2018 | 6 May 2019 | 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 | Not recruiting | 2 Years | 60 Years | All | 600 | N/A | Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT03444220 | January 18, 2018 | 25 March 2019 | 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 | Not recruiting | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | Norway | |
| 37 | NCT03708718 | December 21, 2017 | 22 October 2018 | Prednisolone in Early Diffuse Systemic Sclerosis | A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis | Systemic Sclerosis | Drug: Prednisolone 5 mg;Drug: Placebo oral capsule | Prof. Ariane herrick | Arthritis Research UK | Recruiting | 18 Years | N/A | All | 72 | Phase 2 | United Kingdom |
| 38 | NCT03398837 | December 18, 2017 | 15 July 2019 | 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. | Not recruiting | 18 Years | N/A | All | 365 | Phase 3 | United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom | |
| 39 | NCT03313180 | November 27, 2017 | 4 November 2019 | 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 | Recruiting | 18 Years | N/A | All | 450 | 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 | |
| 40 | NCT03274076 | October 2, 2017 | 26 August 2019 | Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) | Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase I/II Two Center Safety and Tolerability Study | Systemic Sclerosis;Scleroderma | Drug: Tofacitinib;Drug: Placebo Oral Tablet | University of Michigan | Pfizer | Not recruiting | 18 Years | 70 Years | All | 15 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT03222492 | September 20, 2017 | 11 November 2019 | Brentuximab Vedotin for Systemic Sclerosis | Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI) | Diffuse Cutaneous Systemic Sclerosis;Scleroderma;dcSSc | Biological: Brentuximab Vedotin;Biological: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN);Seattle Genetics, Inc. | Recruiting | 18 Years | 70 Years | All | 24 | Phase 1/Phase 2 | United States;Canada |
| 42 | JPRN-JapicCTI-173760 | 01/8/2017 | 16 July 2019 | 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 Dosage And administration of the intervention : 162 mg/week, SC | CHUGAI PHARMACEUTICAL CO., LTD | Recruiting | 18 | BOTH | 18 | Phase 3 | |||
| 43 | JPRN-JapicCTI-173686 | 01/7/2017 | 16 July 2019 | 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 | Kyowa Hakko Kirin Co., Ltd. | Not Recruiting | 18 | 70 | BOTH | 6 | Phase 1 | ||
| 44 | NCT03120533 | June 20, 2017 | 25 March 2019 | Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study | Therapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study | Scleroderma, Systemic | Drug: Iontophoresis of treprostinil;Drug: Iontophoresis of placebo | University Hospital, Grenoble | Linksium;University Grenoble Alps | Recruiting | 18 Years | N/A | All | 36 | Phase 1/Phase 2 | France |
| 45 | NCT03041025 | June 5, 2017 | 7 October 2019 | 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 | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States;Canada;Netherlands;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT03155464 | June 1, 2017 | 26 August 2019 | 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 | Not recruiting | 18 Years | N/A | All | 0 | Phase 4 | ||
| 47 | NCT03068234 | May 2017 | 16 December 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 | Not recruiting | 18 Years | 70 Years | All | 72 | Phase 2/Phase 3 | China | |
| 48 | JPRN-UMIN000026859 | 2017/04/10 | 2 April 2019 | Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis | systemic sclerosis | acotinamaide hydrpchloride 100 mg tablets, 3 times/day, 28 days trimebutine maleateon 100 mg tablets, 3 times/day, 28 days | Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of Medicine | Japanese Cross Society Matsue JCS Hospital Shimane Prefecture central Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 40 | Phase 3 | Japan | |
| 49 | EUCTR2016-002984-32-IT | 16/02/2017 | 12 February 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ILOPROST TROMETAMOL CAS Number: 73873-87-7 Current Sponsor code: ND Other descriptive name: ILOPROST SALE DI TROMETAMOLO Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA Product Name: ENDOPROST Product Code: ND Pharmaceutical Form: Solution for infusion INN or Proposed INN: ILOPROST TROMETAMOL CAS Number: 73873-87-7 Current Sponsor code: ND Other descriptive name: ILOPROST SALE DI TROMETAMOLO Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | Authorised | Female: yes Male: yes | 238 | Phase 4 | Italy | |||
| 50 | EUCTR2016-003417-95-GB | 13/01/2017 | 13 March 2017 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: GSK2330811 CAS Number: N/A Current Sponsor code: GSK2330811 Other descriptive name: GSK2330811 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 40 | Phase 2 | United States;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT02682511 | January 2017 | 26 August 2019 | 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 | Recruiting | 18 Years | 80 Years | All | 34 | Phase 2 | United States;India | |
| 52 | NCT02866552 | January 2017 | 22 August 2016 | SCLERoderma et Adipose-DErived Stroma Cells | Systemic Sclerosis | Drug: Stromal Vascular fraction;Drug: Ringer lactate | Assistance Publique Hopitaux De Marseille | Not recruiting | 18 Years | N/A | Both | 44 | Phase 2 | France | ||
| 53 | NCT03059979 | January 2017 | 30 September 2019 | 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 | Recruiting | 18 Years | N/A | All | 30 | Early Phase 1 | Netherlands | |
| 54 | NCT02981082 | December 2016 | 25 February 2019 | Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension | A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress. | Systemic Sclerosis;Pulmonary; Hypertension | Drug: Dimethyl Fumarate (DMF);Drug: Placebo Oral Tablet | Robert Lafyatis | Biogen | Recruiting | 18 Years | 80 Years | All | 34 | Phase 1 | United States |
| 55 | NCT03007004 | December 2016 | 26 February 2018 | 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: Physiological saline;Drug: Botulinum toxin type B (2500 units / vial) | Gunma University | Not recruiting | 18 Years | N/A | All | 10 | Phase 2 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT03053739 | December 2016 | 16 December 2017 | 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 | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | India | |
| 57 | JPRN-UMIN000024818 | 2016/11/29 | 2 April 2019 | The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis | 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 | Recruiting | 18years-old | Not applicable | Male and Female | 20 | Not selected | Japan | ||
| 58 | NCT02921971 | November 23, 2016 | 23 April 2019 | Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis | Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study | Systemic Sclerosis | Drug: SAR156597 (ACT14604);Drug: Placebo | Sanofi | Not recruiting | 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 | |
| 59 | EUCTR2016-001028-80-DE | 08/11/2016 | 15 October 2018 | 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 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: SAR156597 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 100- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | sanofi-aventis recherche & développement | 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 | |||
| 60 | NCT02975960 | October 25, 2016 | 5 February 2018 | ADMSCs for the Treatment of Systemic Sclerosis | Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Biological: injection of autologous stromal vascular fraction | The Catholic University of Korea | Seoul St. Mary's Hospital | Not recruiting | 18 Years | N/A | All | 7 | N/A | Korea, Republic of |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT02663895 | October 2016 | 7 October 2019 | A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis | Systemic Sclerosis;Calcinosis | Drug: Oral treprostinil | Stanford University | United Therapeutics | Not recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 62 | NCT02896205 | October 2016 | 18 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 41 | Phase 3 | India | |
| 63 | NCT02798055 | September 30, 2016 | 15 July 2019 | 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. | Not recruiting | 18 Years | 80 Years | All | 148 | Phase 1/Phase 2 | Greece | |
| 64 | EUCTR2015-002586-39-DE | 03/08/2016 | 23 July 2018 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: TERGURIDE HYDROGENMALEATE CAS Number: 37686-85-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Terguride Pharmaceutical Form: Tablet INN or Proposed INN: TERGURIDE HYDROGENMALEATE CAS Number: 37686-85-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | medac GmbH | Not Recruiting | Female: yes Male: yes | 148 | Phase 3 | Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland | |||
| 65 | EUCTR2015-000168-32-NL | 13/07/2016 | 5 June 2017 | 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 Pharmaceutical Form: Suspension and solvent for suspension for injection INN or Proposed INN: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS Other descriptive name: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS Concentration unit: CFU/ml colony forming unit(s)/millilitre Concentration type: up to Concentration number: 50000000- Pharmaceutical form of the placebo: Suspension and solvent for suspension for injection Route of administration of the placebo: Intramuscular use | University Medical Center Utrecht | Authorised | Female: yes Male: yes | Phase 2 | Netherlands | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | JPRN-UMIN000022624 | 2016/07/01 | 22 July 2019 | 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 | Not Recruiting | 20years-old | Not applicable | Male and Female | 5 | Not selected | Japan | |
| 67 | EUCTR2015-000392-28-IE | 27/06/2016 | 28 February 2019 | 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 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis System Organ Class: 100000004859 MedDRA version: 19.1 Level: PT Classification code 10042954 Term: Systemic sclerosis pulmonary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1 Level: LLT Classification code 10025109 Term: Lung involvement in systemic sclerosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1 Level: LLT 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 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use | Boehringer Ingelheim Limited | 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 | |||
| 68 | NCT02733978 | June 2016 | 26 February 2018 | 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 | Not recruiting | N/A | N/A | All | 50 | N/A | ||
| 69 | NCT02745145 | May 31, 2016 | 1 April 2019 | Abituzumab in SSc-ILD | A Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) | Systemic Sclerosis-associated Interstitial Lung Disease | Drug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Not recruiting | 18 Years | 75 Years | All | 24 | Phase 2 | United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey |
| 70 | EUCTR2015-004613-24-NL | 30/05/2016 | 13 June 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 Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: methylprednisolon Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Pharmaceutical form of the placebo: Concentrate and solvent for solution for infusion Route of administration of the placebo: Intravenous use | Radboudumc | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2014-002796-28-NL | 12/04/2016 | 18 April 2016 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: bosentan CAS Number: 157212-55-0 Current Sponsor code: ACT-050088 Other descriptive name: BOSENTAN MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 125-250 | University Medical Center Groningen (UMCG) | Authorised | Female: yes Male: yes | Netherlands | |||||
| 72 | NCT02370693 | March 2016 | 16 September 2019 | Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis | Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558 | Interstitial Lung Disease;ILD;Systemic Sclerosis;Scleroderma | Drug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetil | Northwestern University | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 73 | NCT02588625 | February 2016 | 8 August 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | United States;Canada;Poland;United Kingdom;France | |
| 74 | JPRN-JapicCTI-152963 | 08/1/2016 | 5 November 2019 | Phase III Study of Tocilizumab in Patients with Systemic Sclerosis | A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS | Systemic Sclerosis | Intervention name : Tocilizumab INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg/W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo/W, SC | Chugai Pharmaceutical Co., Ltd. | F.Hoffmann-La Roche Ltd | Not Recruiting | 18 | BOTH | 210 | Phase 3 | Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc. | |
| 75 | NCT02642146 | January 2016 | 18 January 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 200 | N/A | Korea, Republic of | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT02453256 | November 20, 2015 | 18 December 2018 | 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 | Not recruiting | 18 Years | N/A | All | 212 | Phase 3 | Bulgaria;Canada;Croatia;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;South Africa;Spain;Switzerland;United Kingdom;United States;Brazil;Argentina;Belgium | |
| 77 | EUCTR2015-000392-28-GB | 10/11/2015 | 28 February 2019 | 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 Level: LLT 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 Level: LLT Classification code 10025109 Term: Lung involvement in systemic sclerosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1 Level: LLT 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 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use | Boehringer Ingelheim Limited | 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 | |||
| 78 | EUCTR2015-000392-28-NL | 02/11/2015 | 3 April 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 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis System Organ Class: 100000004859 MedDRA version: 19.1 Level: PT Classification code 10042954 Term: Systemic sclerosis pulmonary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1 Level: LLT Classification code 10025109 Term: Lung involvement in systemic sclerosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1 Level: LLT 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 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Nintedanib CAS Number: 656247-17-5 Current Sponsor code: BIBF 1120 Other descriptive name: NINTEDANIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use | Boehringer Ingelheim bv | Authorised | 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 | |||
| 79 | EUCTR2015-000424-28-DE | 02/11/2015 | 28 February 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | |||
| 80 | NCT03531216 | November 2, 2015 | 21 January 2019 | Topical Rosemary Oil Application in Systemic Sclerosis | Psychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized Trial | Systemic Sclerosis | Other: Rosemary essential oil;Other: Placebo | ARCIM Institute Academic Research in Complementary and Integrative Medicine | University Hospital Tuebingen | Not recruiting | 18 Years | N/A | All | 12 | N/A | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT02503644 | October 29, 2015 | 18 March 2019 | 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 | Not recruiting | 18 Years | 75 Years | All | 145 | Phase 2 | Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom | |
| 82 | JPRN-UMIN000020389 | 2015/10/01 | 22 July 2019 | 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 | Not Recruiting | 20years-old | Not applicable | Male and Female | 5 | Not selected | Japan | |
| 83 | EUCTR2015-001617-27-IT | 18/09/2015 | 26 February 2018 | A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving. | A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC | Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys. MedDRA version: 18.0 Level: LLT Classification code 10012941 Term: Diffuse scleroderma System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: IVA337 CAS Number: 927961-18-0 Current Sponsor code: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Inventiva SAS | Authorised | Female: yes Male: yes | 105 | Phase 2 | Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy | |||
| 84 | EUCTR2014-005323-27-GB | 16/09/2015 | 28 February 2019 | 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 Level: LLT 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 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Abatacept Current Sponsor code: IM101-344 Other descriptive name: Orencia Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Endotracheopulmonary instillation Route of administration of the placebo: Subcutaneous use | University of Michigan | Not Recruiting | Female: yes Male: yes | 86 | Phase 2 | United States;Canada;Italy;United Kingdom | |||
| 85 | EUCTR2015-001617-27-ES | 08/09/2015 | 4 December 2018 | 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 Level: LLT 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: IVA337 CAS Number: 927961-18-0 Current Sponsor code: IVA337 Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Inventiva SAS | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | EUCTR2015-000424-28-BE | 07/09/2015 | 28 February 2019 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | |||
| 87 | NCT02551042 | September 2015 | 13 June 2016 | CSL Behring Sclero XIII | A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chloride | University College, London | CSL Behring | Recruiting | 18 Years | N/A | Both | 26 | Phase 2 | United Kingdom |
| 88 | NCT02558543 | September 2015 | 18 March 2019 | 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 | Not recruiting | 18 Years | N/A | All | 40 | Phase 2 | France | |
| 89 | NCT02465437 | August 2015 | 9 October 2018 | 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. | Not recruiting | 18 Years | 70 Years | All | 42 | Phase 2 | United States | |
| 90 | JPRN-UMIN000018376 | 2015/07/22 | 23 April 2019 | 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 | Not Recruiting | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT02480335 | June 26, 2015 | 18 December 2018 | The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis | The Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital Ulcers | Scleroderma, Systemic | Drug: bosentan | University Medical Center Groningen | Actelion | Not recruiting | 18 Years | N/A | All | 20 | Phase 4 | Netherlands |
| 92 | NCT02349009 | June 2015 | 16 December 2017 | 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. | Not recruiting | 18 Years | N/A | All | 17 | Phase 1/Phase 2 | United States | |
| 93 | NCT03692299 | June 2015 | 26 August 2019 | 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: Metronidazole;Drug: Saccharomyces Boulardii Oral Tablet | Coordinación de Investigación en Salud, Mexico | Not recruiting | 18 Years | 65 Years | All | 39 | Phase 4 | Mexico | |
| 94 | EUCTR2014-001353-16-GB | 17/04/2015 | 29 May 2017 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT | Bayer AG | Authorised | 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 | |||
| 95 | NCT02356809 | March 2015 | 19 February 2015 | Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's Phenomenon | Safety and Efficacy Study of Pl-vegf165 to Treat Secondary Raynaud's Phenomenon Caused by Systemic Scleroderma | Secondary Raynaud's Phenomenon | Drug: Neovasculgen | Human Stem Cell Institute, Russia | Institute of Rheumatology-Russian Academy of Medical Sciences | Not recruiting | 18 Years | 65 Years | Both | 30 | Phase 1/Phase 2 | Russian Federation |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT02370784 | February 2015 | 18 March 2019 | Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma | The Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic Sclerosis | Scleroderma | Drug: atorvastatin;Drug: Placebo | Robyn T. Domsic, MD, MPH | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | United States |
| 97 | NCT02283762 | January 15, 2015 | 23 April 2019 | 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 | Not recruiting | 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 | |
| 98 | NCT02290613 | December 2014 | 16 December 2017 | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA | Systemic Sclerosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Heidelberg University | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 38 | Phase 2 | Germany |
| 99 | NCT02363478 | December 2014 | 19 October 2017 | 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 | Not recruiting | 18 Years | 75 Years | All | 22 | Early Phase 1 | Greece | |
| 100 | JPRN-UMIN000017617 | 2014/11/01 | 2 April 2019 | Effect of botulinum toxin A on Raynaud's phenomenon in patients with systemic sclerosis | Raynaud's phenomenon | Botulinum toxin A injection | Gunma University Hospital | Not Recruiting | 18years-old | Not applicable | Male and Female | 10 | Not selected | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT02228850 | November 2014 | 11 April 2016 | 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.) | Not recruiting | 18 Years | 79 Years | Both | 35 | Phase 2 | United States | |
| 102 | EUCTR2014-000865-34-DE | 31/10/2014 | 14 March 2016 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Other descriptive name: SELEXIPAG Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom | |||
| 103 | EUCTR2014-001882-28-DE | 13/10/2014 | 8 January 2018 | 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 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Thoraxklinik-Heidelberg gGmbH | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | |||
| 104 | NCT02260557 | October 2014 | 23 May 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 74 | Phase 2 | France;Germany;United Kingdom | |
| 105 | NCT02161406 | September 2014 | 12 November 2018 | A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis | A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial. | Diffuse Cutaneous Systemic Sclerosis | Drug: Abatacept;Drug: Placebo | Dinesh Khanna, MD, MS | Bristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | N/A | All | 88 | Phase 2 | United States;Canada;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT02166229 | June 2014 | 22 August 2016 | Divalproex Sodium in the Treatment of the Cutaneous Manifestations of Scleroderma | Scleroderma;Systemic Sclerosis | Drug: Divalproex sodium | Yale University | Not recruiting | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States | ||
| 107 | NCT02213705 | June 2014 | 25 April 2016 | 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 | Recruiting | 18 Years | 70 Years | Both | 20 | Phase 1/Phase 2 | France | |
| 108 | NCT02212249 | May 2014 | 11 April 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 85 | N/A | France | |
| 109 | JPRN-UMIN000015495 | 2014/04/01 | 21 May 2019 | 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 | Not Recruiting | 20years-old | 80years-old | Male and Female | 5 | Not applicable | Japan | |
| 110 | EUCTR2013-004596-12-IT | 22/01/2014 | 19 February 2018 | 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 Pharmaceutical Form: Concentrate for solution for infusion | Azienda ospedaliera universitaria Ospedali Riuniti | Authorised | Female: yes Male: yes | 20 | Phase 2 | Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
| 112 | JPRN-jRCTs031180370 | 12/11/2013 | 22 July 2019 | Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis | Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis | Systemic sclerosis | Administrate 8 mg/kg of tocilizumab once every four weeks for six months | Ayumi Yoshizaki | Shinichi Sato | Not Recruiting | >=20 age old | <80 age old | Both | 5 | Phase 2 | none |
| 113 | JPRN-UMIN000012214 | 2013/11/05 | 2 April 2019 | 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 | Not Recruiting | 20years-old | 80years-old | Male and Female | 5 | Not applicable | Japan | ||
| 114 | EUCTR2013-001353-28-IT | 04/10/2013 | 10 July 2015 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: PIRFENIDONE CAS Number: 53179-13-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 267- | InterMune Inc. | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Canada;Italy | |||
| 115 | NCT01933334 | October 2013 | 19 October 2017 | 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. | Not recruiting | 18 Years | 75 Years | All | 63 | Phase 2 | United States;Canada;Italy | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | EUCTR2012-004955-35-IT | 29/07/2013 | 17 August 2015 | 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 Pharmaceutical Form: Powder for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI | Authorised | Female: yes Male: yes | Italy | |||||
| 117 | JPRN-JapicCTI-132176 | 01/6/2013 | 2 April 2019 | 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. | 18 | BOTH | 20 | Phase 3 | ||||
| 118 | NCT01878526 | June 2013 | 16 December 2017 | 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 | Not recruiting | 18 Years | 65 Years | All | 80 | Phase 3 | Thailand | |
| 119 | NCT01804959 | May 2013 | 17 September 2018 | 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 | Not recruiting | 18 Years | N/A | All | 40 | Phase 2 | Singapore | |
| 120 | NCT03561233 | May 2013 | 2 July 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 | Not recruiting | 18 Years | N/A | All | 250 | Phase 1 | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | NCT01748084 | April 9, 2013 | 11 June 2018 | Rituximab in Systemic Sclerosis | Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis | Systemic Sclerosis | Drug: Rituximab;Drug: Placebo (NaCl) | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | 80 Years | All | 22 | Phase 2/Phase 3 | France | |
| 122 | NCT01785056 | April 2013 | 23 July 2018 | IVIG Treatment in Systemic Sclerosis | A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis;Diffuse Scleroderma | Biological: Privigen | Georgetown University | CSL Behring | Not recruiting | 18 Years | N/A | All | 14 | N/A | United States |
| 123 | EUCTR2012-005348-92-IT | 19/02/2013 | 15 July 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: PRUCALOPRIDE SUCCINATE Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 2- | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | Authorised | Female: yes Male: no | Italy | |||||
| 124 | NCT01570764 | January 14, 2013 | 4 November 2019 | Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease | Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease | Systemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung Fibrosis | Drug: Cyclophosphamide;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Hôpital Claude-Huriez | Not recruiting | 18 Years | N/A | All | 40 | Phase 3 | France |
| 125 | EUCTR2012-001369-34-GB | 26/10/2012 | 25 March 2013 | 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 Pharmaceutical Form: Tablet CAS Number: 1195941-38-8 Current Sponsor code: SAR100842 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: SAR100842 Pharmaceutical Form: Tablet CAS Number: 1195941-38-8 Current Sponsor code: SAR100842 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Sanofi-aventis recherche & développement | Authorised | Female: yes Male: yes | 30 | United States;Canada;Germany;Switzerland;United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | NCT01895244 | September 2012 | 29 April 2019 | 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 | Recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Germany | |
| 127 | NCT01670565 | August 2012 | 16 December 2017 | Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis | Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study. | Systemic Sclerosis | Drug: Belimumab | Hospital for Special Surgery, New York | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 128 | JPRN-jRCTs031180373 | 14/05/2012 | 22 July 2019 | Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis | Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis - Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis | Interstitial lung disease secondary to systemic sclerosis | Rituximab 375mg/m2 once a week/4 times | Ayumi Yoshizaki | Shinichi Sato | Recruiting | 20 age old | 80 age old | Both | 60 | Phase 2 | none |
| 129 | JPRN-UMIN000007702 | 2012/04/26 | 2 April 2019 | 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 | Recruiting | 20years-old | 80years-old | Male and Female | 20 | Not selected | Japan | ||
| 130 | EUCTR2011-002434-40-DE | 23/03/2012 | 17 July 2012 | 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 sclerosis Modification 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 Pharmaceutical Form: Suspension for infusion | University Hospital Tuebingen | Authorised | Female: yes Male: yes | Germany | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | EUCTR2010-023047-15-DE | 15/03/2012 | 3 April 2017 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pomalidomide CAS Number: 19171-19-8 Current Sponsor code: CC-4047 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene Corporation | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | Sweden;Switzerland;United Kingdom;Italy;Germany;Russian Federation;Australia;Spain;Poland;United States;France | |||
| 132 | NCT02562079 | March 2012 | 16 December 2017 | Vasculopathy, Inflammation and Systemic Sclerosis | Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation | Systemic Sclerosis | Biological: Blood samples;Biological: Biopsy | University Hospital, Bordeaux | Société Française de Rhumatologie | Not recruiting | 18 Years | 75 Years | All | 350 | N/A | France |
| 133 | NCT01497743 | February 2012 | 9 January 2017 | 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 | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | United States | |
| 134 | EUCTR2011-001460-22-GB | 19/01/2012 | 2 June 2014 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd. | Authorised | Female: yes Male: yes | 86 | Phase 2/3 | France;United States;Canada;Germany;United Kingdom | |||
| 135 | EUCTR2010-022969-95-GB | 21/12/2011 | 17 December 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: macitentan Product Code: macitentan Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 295 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT01538719 | December 2011 | 11 June 2018 | IL1-TRAP, Rilonacept, in Systemic Sclerosis | Randomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker Trial | Scleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic Sclerosis | Drug: Rilonacept;Other: Placebo | Boston University | Regeneron Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 24 | Phase 1/Phase 2 | United States |
| 137 | NCT01413100 | September 15, 2011 | 26 August 2019 | Scleroderma Treatment With Autologous Transplant (STAT) Study | A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis | Systemic Scleroderma | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire Administration | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Recruiting | N/A | 70 Years | All | 30 | Phase 2 | United States;Canada |
| 138 | NCT01445821 | September 2011 | 26 August 2019 | 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 | Not recruiting | 17 Years | 60 Years | All | 80 | Phase 3 | United States | |
| 139 | EUCTR2011-001667-44-SE | 28/06/2011 | 27 October 2014 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: paquinimod CAS Number: 248282-01-1 Current Sponsor code: ABR-215757 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- | Active Biotech AB | Not Recruiting | Female: yes Male: yes | 20 | Sweden;Switzerland;Germany | ||||
| 140 | NCT01086540 | June 24, 2011 | 26 August 2019 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | 75 Years | All | 58 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | EUCTR2010-022710-77-DE | 16/06/2011 | 27 October 2014 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: macitentan Product Code: macitentan Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | 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 | ||||
| 142 | JPRN-UMIN000005550 | 2011/06/01 | 2 April 2019 | Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis | Systemic sclerosis | Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies Continue existing conventional therapies | Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine | Rheumatology Keio University, Rheumatology Tokyo Women's Medical University, Dermatology Osaka University | Not Recruiting | 20years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | |
| 143 | NCT01257802 | May 2011 | 16 December 2017 | GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases | GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases | Lupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial Diffuse | Drug: depot leuprolide acetate 3.75 mg;Drug: Placebo | Joseph Mccune | National Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 18 Years | 40 Years | Female | 14 | Phase 3 | United States |
| 144 | NCT01347008 | April 2011 | 19 October 2017 | Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis | Effect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial | Scleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud Phenomenon | Drug: Sildenafil citrate;Drug: Placebo (Sugar pill) | Federal University of São Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | 18 Years | N/A | Female | 41 | Phase 3 | Brazil |
| 145 | NCT01639573 | April 2011 | 21 January 2019 | 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 | Not recruiting | 8 Years | 18 Years | All | 0 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | EUCTR2010-024005-13-GB | 11/03/2011 | 25 September 2012 | 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 Pharmaceutical Form: Capsule Current Sponsor code: ORM-12741 Other descriptive name: alpha-2C AR antagonist Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: ORM-12741 Product Code: ORM-12741 Pharmaceutical Form: Capsule Current Sponsor code: ORM-12741 Other descriptive name: Alpha-2C AR antagonist Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Orion Corporation Orion Pharma | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 147 | NCT01309997 | March 2011 | 19 October 2017 | Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease | A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell Transplantation | Graft Versus Host Disease;Systemic Scleroderma | Drug: imatinib mesylate;Biological: rituximab | Lee, Stephanie | National Cancer Institute (NCI) | Not recruiting | 2 Years | N/A | All | 72 | Phase 2 | United States |
| 148 | NCT01315899 | March 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | 75 Years | Both | 15 | Phase 2 | United Kingdom | |
| 149 | NCT01395732 | March 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 18 | Phase 4 | Netherlands | |
| 150 | NCT01284322 | January 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 18 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | EUCTR2010-019977-14-IT | 04/11/2010 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: CILOSTAZOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA | Authorised | Female: yes Male: yes | Italy | |||||
| 152 | EUCTR2009-018194-31-GB | 03/11/2010 | 19 March 2012 | 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 Phenomenon 2] 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 Pharmaceutical Form: Gel Pharmaceutical form of the placebo: Gel Route of administration of the placebo: Topical use (Noncurrent) | Pharmarama International Limited | Authorised | Female: yes Male: yes | 45 | United Kingdom | ||||
| 153 | NCT01295736 | November 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 84 | Phase 3 | France | |
| 154 | EUCTR2009-013468-37-GB | 29/09/2010 | 19 March 2012 | 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 Level: LLT Classification code 10037917 Term: Raynaud's phenomenon | Trade Name: Asasantin Retard ® Product Name: ASASANTIN Retard Pharmaceutical Form: Capsule* INN or Proposed INN: aspirin CAS Number: 50-78-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- INN or Proposed INN: dipyridamole CAS Number: 58-32-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | Royal National Hospital for Rheumatic Disease | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 155 | EUCTR2009-017869-27-DE | 23/09/2010 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Terguride CAS Number: 37686-84-3 Current Sponsor code: - Other descriptive name: transdihydrolisuride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- | University Hospital Zurich | Authorised | Female: yes Male: yes | 14 | Germany | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | JPRN-UMIN000031940 | 2010/09/07 | 2 April 2019 | 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 | Not Recruiting | 16years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | ||
| 157 | JPRN-UMIN000004162 | 2010/09/01 | 2 April 2019 | 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 | Recruiting | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan | ||
| 158 | NCT01166139 | July 2010 | 16 December 2017 | Nilotinib in the Treatment of Systemic Sclerosis | Phase IIA Study of the Safety and Tolerability of the Use of Nilotinib in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Nilotinib (Tasigna) | Hospital for Special Surgery, New York | Rudolph Rupert Scleroderma Program;Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 159 | NCT02339441 | June 2010 | 23 May 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 320 | N/A | ||
| 160 | NCT01151644 | April 2010 | 19 February 2015 | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Rheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DM | Biological: Anti-pandemic H1N1 influenza vaccine | University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | N/A | N/A | Both | 5000 | Phase 4 | Brazil |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | NCT01072669 | February 2010 | 19 October 2017 | Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet | Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging | Ischemia | Drug: ambrisentan | Soumya Chatterjee | Gilead Sciences | Not recruiting | 18 Years | 70 Years | All | 20 | N/A | United States |
| 162 | NCT01093885 | February 2010 | 10 December 2018 | Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis | An Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic Sclerosis | Systemic Sclerosis;Scleroderma | Drug: Ambrisentan | University of Pennsylvania | Gilead Sciences | Not recruiting | 19 Years | 90 Years | All | 15 | N/A | United States |
| 163 | NCT01042158 | January 2010 | 16 December 2017 | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Pulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary Hypertension | Drug: tadalafil and ambrisentan upfront combination therapy | Johns Hopkins University | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford University | Not recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 164 | NCT01047072 | January 2010 | 19 February 2015 | Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis | Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) | Not recruiting | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 165 | NCT01586663 | January 2010 | 19 February 2015 | 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 | Recruiting | 18 Years | N/A | Both | 76 | Phase 3 | Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | NCT00848107 | September 2009 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 115 | Phase 2 | United States;Canada;United Kingdom | |
| 167 | NCT00962923 | August 2009 | 19 February 2015 | 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 | Recruiting | 15 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | China | ||
| 168 | EUCTR2008-007180-16-NL | 13/05/2009 | 19 March 2012 | 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 Pharmaceutical Form: Powder for infusion* Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | LUMC | Authorised | Female: yes Male: yes | Netherlands | |||||
| 169 | NCT00775463 | May 2009 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 148 | Phase 2 | United States;Canada;United Kingdom | |
| 170 | EUCTR2008-005018-39-GB | 05/03/2009 | 19 March 2012 | 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 Level: LLT Classification code 10039710 Term: Scleroderma | Product Name: treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C-SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 150 | United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | EUCTR2008-006978-15-GB | 05/03/2009 | 19 March 2012 | 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 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: treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Product Name: treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: treprostinil diethanolamine Product Code: UT-15C-SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: treprostinil diethanolamine Product Code: UT-15 SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: n/a Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 450 | United Kingdom;Canada;United States | ||||
| 172 | NCT01051960 | March 2009 | 11 June 2018 | Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan | Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot Study | Systemic Sclerosis;Shortness of Breath;Pulmonary Hypertension | Drug: Ambrisentan | University of California, Los Angeles | Gilead Sciences | Not recruiting | 18 Years | 80 Years | All | 15 | Phase 4 | United States |
| 173 | NCT00769028 | December 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United Kingdom | |
| 174 | NCT00848939 | December 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 28 | Phase 1 | United States | |
| 175 | NCT00442611 | November 2008 | 16 December 2017 | A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma) | A Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Systemic Sclerosis | Scleroderma, Diffuse;Scleroderma, Systemic | Drug: Abatacept;Drug: Placebo | Stanford University | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | EUCTR2006-004598-83-GB | 22/10/2008 | 19 March 2012 | 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 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Current Sponsor code: Cyclophosphamide Concentration unit: g gram(s) Concentration type: equal Concentration number: 28- Trade Name: Neupogen Product Name: Filgrastim Pharmaceutical Form: Injection* INN or Proposed INN: FILGRASTIM CAS Number: 121181531 Concentration unit: µg/kg microgram(s)/kilogram Concentration type: equal Concentration number: 10- Trade Name: Thymoglobuline Product Name: Thymoglobuline Product Code: rbATG Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 2.5- Trade Name: Solu-Medrone Product Name: Methylprednisolone Pharmaceutical Form: Intravenous infusion INN or Proposed INN: METHYLPREDNISOLONE CAS Number: 83432 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 1- Trade Name: Cyclophosphamide Product Name: Cyclophosphamide Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 750- Trade Name: Mesna Product Name: Mesna Pharmaceutical Form: Solution for injection INN or Proposed INN: MESNA CAS Number: 19767454 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Trade Name: Mesna Product Name: Mesna Pharmaceutical Form: Solution for injection INN or Proposed INN: MESNA CAS Number: 19767454 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- | EBMT (European group for Blood and Marrow Transplantation) | Authorised | Female: yes Male: yes | 150 | United Kingdom | ||||
| 177 | EUCTR2008-000224-27-GB | 15/10/2008 | 19 March 2012 | 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 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: METHYLPREDNISOLONE CAS Number: 83432 Current Sponsor code: MP Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Product Name: cyclophosphamide Product Code: cyclophosphamide Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CYCLOPHOSPHAMIDE CAS Number: 50180 Current Sponsor code: CYC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- | Newcastle upon Tyne NHS Foundation Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 178 | NCT00984932 | September 2008 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Both | 40 | Phase 3 | Egypt | |
| 179 | EUCTR2005-003775-21-GB | 14/08/2008 | 19 March 2012 | Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis | Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis | Systemic sclerosis (also termed 'scleroderma') | Trade Name: Lipitor Product Name: Lipitor Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Salford Royal Hospitals NHS Trust | University of Manchester | Authorised | Female: yes Male: yes | 36 | United Kingdom | |||
| 180 | EUCTR2008-001265-28-ES | 17/06/2008 | 19 March 2012 | “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 sistémica 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 Pharmaceutical Form: Cream INN or Proposed INN: P144 CAS Number: 272105-42-7 Current Sponsor code: P144 Other descriptive name: DIGNA P144 cream Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.03%- | ISDIN | Authorised | Female: yes Male: yes | 98 | Hungary;United Kingdom;Germany;Spain;Italy | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | NCT00725361 | June 2008 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 20 | N/A | United States | |
| 182 | EUCTR2007-003621-24-FR | 29/05/2008 | 19 March 2012 | 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 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Aviptadil CAS Number: 40077-57-4 Other descriptive name: VIP Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use | MondoGEN AG | Authorised | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | ||||
| 183 | EUCTR2007-003122-24-GB | 09/04/2008 | 19 March 2012 | 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 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma MedDRA version: 9.1 Level: LLT Classification code 10012941 Term: Diffuse scleroderma MedDRA version: 9.1 Level: LLT Classification code 10018124 Term: Generalized scleroderma MedDRA version: 9.1 Level: LLT Classification code 10042954 Term: Systemic sclerosis pulmonary | Product Name: AIMSPRO Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Daval International Limited | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 184 | EUCTR2007-004669-17-GB | 15/02/2008 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: imatinib CAS Number: 220127-57-1 Current Sponsor code: STI571 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 27 | United Kingdom;Italy | ||||
| 185 | NCT00613171 | January 2008 | 22 October 2018 | Efficacy and Tolerability of STI571 (Imatinib Mesylate) 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, Scleroderma | Drug: STI571 | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 27 | Phase 2 | United States;Germany;Italy;Switzerland;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | NCT00909337 | January 2008 | 19 February 2015 | Early Therapy of Pulmonary Arterial Hypertension | Early Therapy of Pulmonary Arterial Hypertension | Pulmonary Hypertension;Systemic Sclerosis | Drug: Bosentan | Medical University of Graz | Actelion | Not recruiting | 18 Years | 90 Years | Both | 10 | N/A | Austria |
| 187 | NCT00479934 | December 2007 | 19 February 2015 | Efficacy and Safety of Imatinib in Scleroderma | Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement. | Scleroderma, Localized;Scleroderma, Systemic | Drug: imatinib mesylate | University Hospital, Bordeaux | Ministry of Health, France;Novartis | Not recruiting | 18 Years | N/A | Both | 28 | Phase 2 | France |
| 188 | NCT00581997 | December 2007 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 8 | Phase 2 | United States | |
| 189 | EUCTR2007-006035-32-IT | 15/11/2007 | 19 March 2012 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | AZIENDA OSPEDALIERA PISANA | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 190 | EUCTR2007-005322-68-IT | 30/10/2007 | 19 March 2012 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Imatinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | Authorised | Female: yes Male: yes | Phase 2 | Italy | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | EUCTR2007-002015-38-HU | 04/09/2007 | 29 May 2012 | 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 Pharmaceutical Form: Cream CAS Number: 272105-42-7 Current Sponsor code: P144 Other descriptive name: DIGNA P144 CREAM Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0.03%- Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Topical use (Noncurrent) | ISDIN | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 192 | EUCTR2006-007091-15-NL | 03/09/2007 | 19 March 2012 | 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 Pharmaceutical Form: Capsule* | ErasmusMC | Authorised | Female: yes Male: yes | 10 | Netherlands | ||||
| 193 | EUCTR2007-002015-38-ES | 23/08/2007 | 29 May 2012 | 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 SISTÉMICA 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 | 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 SISTÉMICA 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 | FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICA SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma | Product Name: P144 Product Code: P144 Pharmaceutical Form: Cream CAS Number: 272105-42-7 Current Sponsor code: P144 Other descriptive name: DIGNA P144 CREAM Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0.03%- Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Topical use (Noncurrent) | ISDIN | Authorised | Female: yes Male: yes | 98 | Phase 2 | Hungary;Germany;United Kingdom;Spain;Italy | |||
| 194 | NCT00512902 | August 2007 | 19 October 2017 | A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic Sclerosis | Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis | Alveolitis;Systemic Sclerosis | Drug: Imatinib | University of California, Los Angeles | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
| 195 | NCT00555581 | August 2007 | 19 February 2015 | Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis | Phase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Imatinib Mesylate | Hospital for Special Surgery, New York | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 30 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT00684255 | August 2007 | 19 October 2017 | 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 | Not recruiting | 7 Years | 50 Years | All | 1 | Phase 1 | United States | |
| 197 | NCT00506831 | July 2007 | 20 August 2018 | Imatinib in Systemic Sclerosis | A Pilot Study of Imatinib in the Treatment of Refractory Systemic Sclerosis | Scleroderma, Systemic | Drug: Imatinib mesylate | Stanford University | Not recruiting | 18 Years | 80 Years | All | 9 | Phase 1/Phase 2 | United States | |
| 198 | NCT00463125 | March 2007 | 19 February 2015 | 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 | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 2/Phase 3 | Italy | |
| 199 | NCT00428883 | January 2007 | 19 February 2015 | 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 | Recruiting | 18 Years | 80 Years | Both | 45 | Phase 2/Phase 3 | Italy | |
| 200 | NCT00379431 | November 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 40 | Phase 2 | Belgium | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2006-002081-19-NL | 16/10/2006 | 19 March 2012 | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis A 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 Sclerosis A 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 Pharmaceutical Form: Intravenous infusion | VU University Medical Centre | Authorised | Female: yes Male: yes | 20 | Phase 2 | Netherlands | |||
| 202 | EUCTR2006-003957-25-IT | 13/10/2006 | 19 March 2012 | Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidly progressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc | Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidly progressive 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Acetylcysteine CAS Number: 616-91-1 Concentration unit: g gram(s) Concentration type: equal Concentration number: 5- Trade Name: ENDOPROST 50*INFUS 1F 0,050MG/ Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Iloprost Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .05- | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | Authorised | Female: yes Male: yes | Italy | |||||
| 203 | EUCTR2006-003836-31-BE | 06/09/2006 | 7 October 2014 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | University Hospital Gent | Authorised | Female: yes Male: yes | Belgium | |||||
| 204 | NCT00622895 | September 1, 2006 | 11 June 2018 | Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis | Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma;Severe Systemic Sclerosis | Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy | Fred Hutchinson Cancer Research Center | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | N/A | 70 Years | All | 3 | Phase 1/Phase 2 | United States |
| 205 | NCT00377455 | September 2006 | 11 June 2018 | Placebo Controlled Trial of Bosentan in Scleroderma Patients | Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension | Systemic Scleroderma;Pulmonary Hypertension | Drug: Bosentan;Drug: Placebo | Georgetown University | Actelion | Not recruiting | 18 Years | N/A | All | 5 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | EUCTR2006-005230-20-IT | 14/07/2006 | 12 November 2012 | 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 Pharmaceutical Form: Capsule, hard Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | OSPEDALE MAGGIORE DI MILANO (IRCCS) | Authorised | Female: yes Male: yes | Italy | |||||
| 207 | NCT00348296 | July 2006 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 60 | Phase 3 | Japan | |
| 208 | EUCTR2006-000905-41-AT | 07/06/2006 | 7 November 2016 | 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 Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use | ao. Univ. Prof. Dr. Elisabeth Aberer | Not Recruiting | Female: yes Male: yes | Phase 4 | Austria | ||||
| 209 | NCT00318175 | June 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 10 | Phase 2 | Germany | |
| 210 | NCT00433186 | March 2006 | 19 February 2015 | Mycophenolate Mofetil in Systemic Sclerosis | Phase I, Open-label Study of Mycophenolate Mofetil In Systemic Sclerosis | Diffuse Cutaneous Systemic Sclerosis | Drug: Mycophenolate Mofetil | Boston University | Aspreva Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 30 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT00278525 | September 2005 | 19 October 2017 | 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 | Not recruiting | N/A | 60 Years | All | 19 | Phase 2 | United States | |
| 212 | NCT00114530 | June 2005 | 16 December 2017 | 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) | Not recruiting | 18 Years | 69 Years | All | 75 | Phase 2/Phase 3 | United States;Canada | |
| 213 | NCT00282425 | May 2005 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 8 | Phase 1 | United States | |
| 214 | EUCTR2004-000632-82-IT | 06/04/2005 | 19 March 2012 | 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: PT Classification code 10059084 | Trade Name: TRACLEER*56CPR RIV 125MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bosentan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | ACTELION PHARMACEUTICALS ITALIA | Not Recruiting | Female: yes Male: yes | 180 | Italy | ||||
| 215 | JPRN-UMIN000020701 | 2005/03/10 | 2 April 2019 | 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 | Not Recruiting | Not applicable | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | NCT00226889 | January 2005 | 19 February 2015 | Treatment of Early Systemic Sclerosis by Bosentan | Systemic Sclerosis (Scleroderma) | Drug: bosentan | Rikshospitalet University Hospital | Not recruiting | 18 Years | 70 Years | Both | 30 | Phase 1/Phase 2 | Norway | ||
| 217 | EUCTR2004-000632-82-GB | 16/09/2004 | 17 October 2016 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 147536-97-8 Current Sponsor code: Ro47-0203/029 Concentration unit: % percent Concentration type: range Concentration number: 98.0-102.0 | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 180 | Phase 3 | Italy;United Kingdom | |||
| 218 | EUCTR2004-000631-28-IT | 14/09/2004 | 19 March 2012 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bosentan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | ACTELION PHARMACEUTICALS ITALIA | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 219 | NCT00319033 | July 2004 | 11 May 2015 | 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 | Not recruiting | 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 | |
| 220 | NCT00319696 | July 2004 | 19 October 2017 | Bosentan in Digital Ulcers | Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers | Systemic Sclerosis;Digital Ulcers | Drug: bosentan | Actelion | Not recruiting | 18 Years | N/A | All | 116 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | NCT00624273 | February 2004 | 19 February 2015 | 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 | Not recruiting | 18 Years | 80 Years | Both | 17 | Phase 2 | Germany | |
| 222 | NCT00077584 | October 2003 | 7 November 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 | Digital Ulcers;Systemic Sclerosis | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | Not recruiting | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada | |
| 223 | NCT02800993 | October 2003 | 27 June 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 | Not recruiting | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada | |
| 224 | NCT00070590 | July 2003 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom | |
| 225 | NCT00241189 | August 2002 | 18 April 2016 | 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 | Not recruiting | 18 Years | 70 Years | Both | 17 | Phase 1/Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | NCT00040651 | July 2002 | 19 February 2015 | Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients | Transplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study | Scleroderma;Systemic Sclerosis | Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Thymoglobulin;Procedure: Leukapheresis;Procedure: Self bone marrow transplant | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | University of Pittsburgh;Amgen;Genzyme, a Sanofi Company | Not recruiting | 18 Years | 70 Years | Both | 15 | Phase 1 | United States |
| 227 | NCT00043706 | May 2002 | 16 March 2015 | Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis | A Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis | Systemic Sclerosis;Scleroderma | Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody | Genzyme, a Sanofi Company | Cambridge Antibody Technology | Not recruiting | 18 Years | 75 Years | Both | Phase 1/Phase 2 | United States | |
| 228 | NCT00707187 | July 2001 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Female | 120 | Phase 2 | United States | |
| 229 | NCT00501995 | February 2001 | 16 December 2017 | High Dose Cyclophosphamide for Treatment of Scleroderma | High Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma) | Scleroderma | Drug: IV Cyclophosphamide | Johns Hopkins University | Not recruiting | 18 Years | 70 Years | All | 6 | Phase 3 | United States | |
| 230 | NCT00418132 | August 2000 | 11 April 2016 | Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis | T Cell Immunity in Collagen Biosynthesis of Scleroderma | Scleroderma, Systemic | Drug: Thalidomide;Drug: Placebo thalidomide | New York University School of Medicine | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | 65 Years | Both | 30 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT00016458 | June 2000 | 19 February 2015 | 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 | Not recruiting | N/A | 64 Years | Both | 20 | Phase 2 | United States | ||
| 232 | NCT00004563 | August 1999 | 19 October 2017 | 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) | Not recruiting | 18 Years | N/A | All | 158 | Phase 3 | |
| 233 | NCT00058578 | June 1999 | 19 February 2015 | Stem Cell Transplant to Treat Patients With Systemic Sclerosis | Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body Irradiation | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Not recruiting | 18 Years | 65 Years | Both | 24 | Phase 1 | United States |
| 234 | NCT00704665 | December 1998 | 19 February 2015 | 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 | Not recruiting | 18 Years | 70 Years | Both | 231 | Phase 3 | |
| 235 | NCT00622687 | September 1997 | 19 February 2015 | Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis | Comparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment Course | Systemic Sclerosis | Drug: iloprost;Drug: iloprost low dose;Drug: iloprost therapy up to 2 ng/kg x min | Charite University, Berlin, Germany | Schering-Plough | Not recruiting | 18 Years | 80 Years | Both | 50 | Phase 2 | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT00004786 | December 1995 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 200 | Phase 3 | ||
| 237 | NCT00004380 | December 1991 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Both | 1 | Phase 2 |