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 51. 全身性強皮症 [臨床試験数:237,薬物数:287(DrugBank:98),標的遺伝子数:78,標的パスウェイ数:52] 

Searched query = "Systemic scleroderma", "Systemic sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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Inclusion_
agemin
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PhaseCountries
1NCT04138485November 20194 November 2019Efficacy 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 SclerosisDiffuse Cutaneous Systemic SclerosisBiological: IgPro10;Biological: PlaceboCSL BehringNot recruiting18 YearsN/AAll144Phase 2
2NCT04040322October 14, 201928 October 2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisA 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 SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.Recruiting18 YearsN/AAll160Phase 3United States
3NCT04095351October 1, 201930 September 2019Connective Tissue Diseases and Lung ManifestationsConnective Tissue Diseases and Lung Manifestations Prospective Trial With Focus on Systemic Sclerosis (Colipris)Connective Tissue Diseases;Interstitial Lung Disease;Systemic SclerosisDiagnostic Test: Pulmonary function test;Diagnostic Test: Imaging;Biological: Blood samplingMedical University InnsbruckBoehringer IngelheimNot recruiting18 Years80 YearsAll120N/A
4NCT04137224September 19, 201911 November 2019Safety 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 SclerosisBiological: IgPro20;Biological: IgPro10CSL BehringNot recruiting18 YearsN/AAll26Phase 2Germany;Poland
5NCT03844061July 29, 201926 August 2019Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisA Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Belimumab;Drug: Rituximab;Other: Placebo Subcutaneous Injection;Other: Placebo Infusion;Drug: MMFHospital for Special Surgery, New YorkGlaxoSmithKlineRecruiting18 Years80 YearsAll30Phase 2United States
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
6NCT03976648July 18, 20194 November 2019A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic SclerosisA Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic SclerosisSclerosis, SystemicDrug: GLPG1690Galapagos NVRecruiting18 YearsN/AAll30Phase 2United States;Spain;United Kingdom
7NCT03919799July 9, 201930 September 2019KD025 in Subjects With Diffuse Cutaneous Systemic SclerosisA 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 SclerosisSystem; Sclerosis;Diffuse Cutaneous Systemic SclerosisDrug: KD025;Drug: PlaceboKadmon Corporation, LLCRecruiting18 Years100 YearsAll60Phase 2United States
8JPRN-JapicCTI-19476123/5/20197 October 2019A Phase 3 study of KHK4827 in patients with systemic sclerosisA Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickeningSystemic sclerosisIntervention name : KHK4827
INN of the intervention : Brodalumab
Dosage And administration of the intervention : 210 mg Q2W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 210 mg Q2W, SC
Kyowa Kirin Co., Ltd.Recruiting1870BOTH100Phase 3Japan
9NCT03957681May 23, 201916 September 2019A Phase 3 Study of KHK4827 in Patients With Systemic SclerosisA Phase 3, Placebo-controlled, Double-blind Comparative Study of KHK4827 With an Open-label Extension Period in Subjects With Systemic Sclerosis Who Have Moderate to Severe Skin ThickeningModerate to Severe Systemic SclerosisDrug: KHK4827;Drug: PlaceboKyowa Kirin Co., Ltd.Recruiting18 Years70 YearsAll100Phase 3Japan
10NCT03198689May 7, 20193 June 2019Brentuximab Vedotin in Early Diffuse Cutaneous Systemic SclerosisA Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)Diffuse Cutaneous Systemic SclerosisDrug: Brentuximab VedotinLawson Health Research InstituteSeattle Genetics, Inc.Recruiting18 YearsN/AAll10Phase 2Canada
No.TrialIDDate_
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PhaseCountries
11NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA 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 NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
12NCT03867097March 4, 201924 June 2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisA Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: Iloprost Injection, for intravenous use;Drug: Placebo IV infusionEicos Sciences, Inc.Not recruiting18 YearsN/AAll40Phase 2United States
13NCT03798366January 14, 20197 October 2019A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic SclerosisA 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 SclerosisSclerodermaDrug: GLPG1690;Drug: PlaceboGalapagos NVRecruiting18 YearsN/AAll30Phase 2United States;Belgium;Germany;Italy;Spain;United Kingdom
14NCT03831438January 1, 20199 September 2019Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic SclerosisA 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 SclerosisScleroderma, DiffuseDrug: AVID200Formation BiologicsRecruiting18 YearsN/AAll24Phase 1United States
15NCT03817424December 13, 201830 September 2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA 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 DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioRecruiting18 Years75 YearsAll32Phase 1United States;Poland;Spain
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
16EUCTR2018-001719-65-NL10/12/201828 February 2019CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc studyCALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc studySystemic 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 GroningenAuthorised Female: yes
Male: yes
120Phase 4Netherlands
17NCT03675581November 8, 20184 November 2019A 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, SystemicDrug: Microgynon;Drug: NintedanibBoehringer IngelheimNot recruiting18 YearsN/AFemale17Phase 1Belgium;France;Germany;Netherlands;Portugal;Spain
18NCT03211793November 201818 June 2018Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic SclerosisMesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS TrialSystemic Sclerosis;Digital UlcerDrug: Mesenchymal stromal cells;Other: PlaceboUMC UtrechtZonMw: The Netherlands Organisation for Health Research and DevelopmentNot recruiting18 YearsN/AAll20Phase 1/Phase 2Netherlands
19NCT03717961October 15, 201826 November 2018Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisMulticenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Study to Assess Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: BOTOX® solution;Drug: Placebo groupAssistance Publique - Hôpitaux de ParisRecruiting18 YearsN/AAll90Phase 3France
20NCT03575156September 20, 20189 October 2018Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisMicroparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic SclerosisSystemic Lupus Erythematosus;Systemic SclerodermaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxRecruiting18 YearsN/AAll200N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
21EUCTR2016-003417-95-NL18/09/20181 October 2018Proof 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 LtdAuthorisedFemale: yes
Male: yes
40Phase 2United States;Canada;Netherlands;United Kingdom
22NCT03678987September 13, 20181 October 2018Mycophenolate Mofetil Pharmacokinetics in Systemic SclerosisMycophenolate Mofetil in Systemic Sclerosis: A Phase 1 Pharmacokinetic Study of Orally Ingested Mycophenolate Mofetil Tablets in Patients Suffering From Systemic SclerosisSystemic Sclerosis;Gastrointestinal ComplicationDiagnostic Test: P-MPA concentration;Drug: mycophenolic acidRegion SkaneRecruiting18 YearsN/AAll35N/ASweden
23NCT03593902September 7, 201826 August 2019Cardiac Safe Transplants for Systemic SclerosisAutologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac DysfunctionSystemic Sclerosis;SclerodermaDrug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNot recruiting18 Years65 YearsAll50Phase 2/Phase 3United States
24NCT03629002September 201820 August 2018BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIABIOLOGICAL 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 HANDSystemic SclerodermaBiological: Study of the gene expression profileAssistance Publique Hopitaux De MarseilleNot recruiting18 YearsN/AAll30N/AFrance
25NCT03558854August 28, 201811 November 2019Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma PatientsEvaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic SclerosisSystemic SclerosisDrug: Acetylsalicylic acid;Drug: Placebo oral capsuleFederal University of São PauloRecruiting18 Years65 YearsAll70Phase 4Brazil
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
26NCT03630211July 31, 201815 April 2019Autologous Stem Cell Transplantation in Patients With Systemic SclerosisAutologous 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 HypertensionDrug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body IrradiationPaul SzabolcsRecruiting16 Years70 YearsAll8Phase 2United States
27JPRN-jRCTs03118036621/06/20187 October 2019The Effectiveness of Glycyrrhizin in Systemic SclerosisExploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic SclerosisSystemic sclerosisTreatment with Glycyrrhizin for systemic sclerosisHayakazu SumidaRecruiting>= 20age old< 80age oldBoth20N/Anone
28NCT03856853June 15, 201811 March 2019Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung DiseaseA 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: placeboBeijing Continent Pharmaceutical Co, Ltd.Shanghai Genomics, Inc.;GNI-EPS Pharmaceuticals, Inc. (GNI Group)Recruiting18 Years75 YearsAll144Phase 3China
29NCT03365869June 1, 201816 December 2017A Pilot-Study of Sirolimus for the Treatment of Systemic SclerosisA Phase ? Pilot-Study With Sirolimus for the Treatment of Systemic SclerosisSystemic SclerosisDrug: SirolimusPeking University People's HospitalNot recruiting18 Years80 YearsAll72Phase 2
30NCT03508375May 15, 201815 July 2019Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic SclerosisEvaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic SclerosisSystemic SclerodermaBiological: blood samplesAssistance Publique Hopitaux De MarseilleRecruiting18 YearsN/AAll75N/AFrance
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
31NCT03607071May 15, 201826 August 2019Outcome of Steroid Therapy for Myocardial Inflammation in SclerodermaOutcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label StudyMyocardial InflammationDrug: Prednisolone and taperKhon Kaen UniversityRecruiting18 YearsN/AAll30Phase 2Thailand
32EUCTR2017-000372-29-ES25/04/201811 June 2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic SclerosisSystemic 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.AuthorisedFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
33JPRN-UMIN0000319012018/04/012 April 2019Efficacy of acotiamide for scleroderma patients with esophageal symptomssystemic sclerosisproton pump inhibitor
proton pump inhibitor and acotiamide
Juntendo University School of MedicineJuntendo Tokyo Koto Geriatric Medical CenterRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
34EUCTR2017-000372-29-DE07/03/201828 February 2019A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic SclerosisSystemic 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
354Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
35NCT03430388January 31, 20186 May 2019Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNot recruiting2 Years60 YearsAll600N/ABrazil
No.TrialIDDate_
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PhaseCountries
36NCT03444220January 18, 201825 March 2019Gut Microbiota Transplantation in Systemic SclerosisReduce Disease Activity in Systemic Sclerosis by Transplantation of an Anaerobically Cultivated Human Intestinal Microbiota, a Controlled Interventional Pilot TrialScleroderma, SystemicBiological: Anaerobically Cultivated Human Intestinal Microbiota;Biological: Anaerobically Cultivated mediumOslo University HospitalNot recruiting18 YearsN/AFemale10Phase 1/Phase 2Norway
37NCT03708718December 21, 201722 October 2018Prednisolone in Early Diffuse Systemic SclerosisA Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Prednisolone 5 mg;Drug: Placebo oral capsuleProf. Ariane herrickArthritis Research UKRecruiting18 YearsN/AAll72Phase 2United Kingdom
38NCT03398837December 18, 201715 July 2019Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsuleCorbus Pharmaceuticals Inc.Not recruiting18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
39NCT03313180November 27, 20174 November 2019A 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, InterstitialDrug: NintedanibBoehringer IngelheimRecruiting18 YearsN/AAll450Phase 3United 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
40NCT03274076October 2, 201726 August 2019Evaluation 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 StudySystemic Sclerosis;SclerodermaDrug: Tofacitinib;Drug: Placebo Oral TabletUniversity of MichiganPfizerNot recruiting18 Years70 YearsAll15Phase 1/Phase 2United States
No.TrialIDDate_
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PhaseCountries
41NCT03222492September 20, 201711 November 2019Brentuximab Vedotin for Systemic SclerosisEvaluation 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;dcSScBiological: Brentuximab Vedotin;Biological: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Seattle Genetics, Inc.Recruiting18 Years70 YearsAll24Phase 1/Phase 2United States;Canada
42JPRN-JapicCTI-17376001/8/201716 July 2019Tocilizumab LTE study in patients with SScA PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSISSystemic sclerosisIntervention name : tocilizumab
Dosage And administration of the intervention : 162 mg/week, SC
CHUGAI PHARMACEUTICAL CO., LTDRecruiting18BOTH18Phase 3
43JPRN-JapicCTI-17368601/7/201716 July 2019A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosisA Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosissystemic sclerosisIntervention name : KHK4827
INN of the intervention : brodalumab
Dosage And administration of the intervention : SC, 210 mg Q2W
Kyowa Hakko Kirin Co., Ltd.Not Recruiting1870BOTH6Phase 1
44NCT03120533June 20, 201725 March 2019Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyTherapeutic Iontophoresis of Treprostinil in Systemic Sclerosis Digital UlcErations. A Proof of Concept StudyScleroderma, SystemicDrug: Iontophoresis of treprostinil;Drug: Iontophoresis of placeboUniversity Hospital, GrenobleLinksium;University Grenoble AlpsRecruiting18 YearsN/AAll36Phase 1/Phase 2France
45NCT03041025June 5, 20177 October 2019Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic SclerosisA 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 SclerosisScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineRecruiting18 YearsN/AAll40Phase 2United States;Canada;Netherlands;United Kingdom
No.TrialIDDate_
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PhaseCountries
46NCT03155464June 1, 201726 August 2019Intraoperative ICG for Systemic SclerosisA Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic ScerlosisSystemic SclerosisProcedure: Order of two elements of surgical procedure;Drug: Indocyanine GreenDuke UniversityNot recruiting18 YearsN/AAll0Phase 4
47NCT03068234May 201716 December 2017Pirfenidone as Treatment of Skin Fibrosis in Systemic SclerosisA Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic SclerosisSystemic SclerosisDrug: Pirfenidone;Drug: Placebo oral capsule;Drug: SteroidsRenJi HospitalNot recruiting18 Years70 YearsAll72Phase 2/Phase 3China
48JPRN-UMIN0000268592017/04/102 April 2019Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosissystemic sclerosisacotinamaide hydrpchloride
100 mg tablets, 3 times/day, 28 days
trimebutine maleateon
100 mg tablets, 3 times/day, 28 days
Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of MedicineJapanese Cross Society Matsue JCS Hospital Shimane Prefecture central HospitalNot Recruiting20years-oldNot applicableMale and Female40Phase 3Japan
49EUCTR2016-002984-32-IT16/02/201712 February 2018NDTreatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - NDSISTEMIC 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. GEMELLIAuthorisedFemale: yes
Male: yes
238Phase 4Italy
50EUCTR2016-003417-95-GB13/01/201713 March 2017Proof 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 LtdAuthorisedFemale: yes
Male: yes
40Phase 2United States;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
51NCT02682511January 201726 August 2019Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA 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 DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsRecruiting18 Years80 YearsAll34Phase 2United States;India
52NCT02866552January 201722 August 2016SCLERoderma et Adipose-DErived Stroma CellsSystemic SclerosisDrug: Stromal Vascular fraction;Drug: Ringer lactateAssistance Publique Hopitaux De MarseilleNot recruiting18 YearsN/ABoth44Phase 2France
53NCT03059979January 201730 September 2019The 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 PhenomenaDrug: Methylprednisolone;Other: sodium chlorideRadboud UniversityRecruiting18 YearsN/AAll30Early Phase 1Netherlands
54NCT02981082December 201625 February 2019Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA 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; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenRecruiting18 Years80 YearsAll34Phase 1United States
55NCT03007004December 201626 February 2018Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic SclerosisTrial to Confirm the Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic SclerosisSystemic Sclerosis Patients With Digital UlcersDrug: Physiological saline;Drug: Botulinum toxin type B (2500 units / vial)Gunma UniversityNot recruiting18 YearsN/AAll10Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
56NCT03053739December 201616 December 2017To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchRecruiting18 YearsN/AAll50Phase 4India
57JPRN-UMIN0000248182016/11/292 April 2019The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosisdigital ulcers in systemic sclerosis patientsplacebo subcutaneously injection into hands with digital ulcers
botulinum toxin type B subcutaneously injection into hands with digital ulcers
Gunma University HospitalRecruiting18years-oldNot applicableMale and Female20Not selectedJapan
58NCT02921971November 23, 201623 April 2019Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept StudySystemic SclerosisDrug: SAR156597 (ACT14604);Drug: PlaceboSanofiNot recruiting18 YearsN/AAll97Phase 2United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
59EUCTR2016-001028-80-DE08/11/201615 October 2018Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept studySystemic 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 & développementNot RecruitingFemale: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
60NCT02975960October 25, 20165 February 2018ADMSCs for the Treatment of Systemic SclerosisAdipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic SclerosisSystemic SclerosisBiological: injection of autologous stromal vascular fractionThe Catholic University of KoreaSeoul St. Mary's HospitalNot recruiting18 YearsN/AAll7N/AKorea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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Target_
size
PhaseCountries
61NCT02663895October 20167 October 2019A Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic SclerosisA Pilot Study to Evaluate the Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic SclerosisSystemic Sclerosis;CalcinosisDrug: Oral treprostinilStanford UniversityUnited TherapeuticsNot recruiting18 YearsN/AAll12Phase 2United States
62NCT02896205October 201618 June 2018Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung DiseaseA Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: PlaceboPostgraduate Institute of Medical Education and ResearchNot recruiting18 YearsN/AAll41Phase 3India
63NCT02798055September 30, 201615 July 2019Bosentan Treatment of Digital Ulcers Related to Systemic SclerosisA National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.Systematic Sclerosis;Digital Ulcer;SclerodermaDrug: Bosentan groupElpen Pharmaceutical Co. Inc.Not recruiting18 Years80 YearsAll148Phase 1/Phase 2Greece
64EUCTR2015-002586-39-DE03/08/201623 July 2018Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISSDiffuse 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 GmbHNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
65EUCTR2015-000168-32-NL13/07/20165 June 2017Mesenchymal stem cells as treatment for non healing wounds on the fingers in patients with systemic sclerosisMesenchymal stem cells for Angiogenesis and Neovascularization in digital Ulcers of Systemic sclerosis - MANUS Trialsystemic 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 UtrechtAuthorisedFemale: yes
Male: yes
Phase 2Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
66JPRN-UMIN0000226242016/07/0122 July 2019Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHDClinical 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 GVHDThe 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 HospitalNot Recruiting20years-oldNot applicableMale and Female5Not selectedJapan
67EUCTR2015-000392-28-IE27/06/201628 February 2019A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA 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-ILDPatients 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 LimitedNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;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
68NCT02733978June 201626 February 2018Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic SclerosisNon-invasive Oxygen-Ozone Therapy in the Treatment of Digital Ulcers in Egyptian Patients With Systemic SclerosisUlcer;SclerodermaDevice: the ozone generator device (Human Pro medic, German)Assiut UniversityNot recruitingN/AN/AAll50N/A
69NCT02745145May 31, 20161 April 2019Abituzumab in SSc-ILDA Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung DiseaseDrug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyNot recruiting18 Years75 YearsAll24Phase 2United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
70EUCTR2015-004613-24-NL30/05/201613 June 2016Hit hard and earlyHit 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
RadboudumcAuthorisedFemale: yes
Male: yes
Phase 4Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
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agemin
Inclusion_
agemax
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Target_
size
PhaseCountries
71EUCTR2014-002796-28-NL12/04/201618 April 2016Does 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 STIFFNESSSystemic 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)AuthorisedFemale: yes
Male: yes
Netherlands
72NCT02370693March 201616 September 2019Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary FibrosisComparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis Grant Number: R34HL122558Interstitial Lung Disease;ILD;Systemic Sclerosis;SclerodermaDrug: Bortezomib;Drug: Placebo;Drug: Mycophenolate mofetilNorthwestern UniversityNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 YearsN/AAll30Phase 2United States
73NCT02588625February 20168 August 2016A 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)SclerodermaDrug: BMS-986020;Other: PlaceboBristol-Myers SquibbNot recruiting18 YearsN/ABoth0Phase 2United States;Canada;Poland;United Kingdom;France
74JPRN-JapicCTI-15296308/1/20165 November 2019Phase III Study of Tocilizumab in Patients with Systemic SclerosisA PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSISSystemic SclerosisIntervention name : Tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo/W, SC
Chugai Pharmaceutical Co., Ltd.F.Hoffmann-La Roche LtdNot Recruiting18BOTH210Phase 3Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.
75NCT02642146January 201618 January 2016Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort StudyRaynaud Disease;Systemic Sclerosis;Digital UlcerDrug: Calcium Channel Blockers;Drug: Phosphodiesterase Inhibitors;Drug: Endothelin receptor blocker;Drug: Prostanoids;Drug: Other vasodilatorSeoul National University HospitalNot recruiting18 YearsN/ABoth200N/AKorea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
76NCT02453256November 20, 201518 December 2018A 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 SclerosisSystemic SclerosisDrug: Placebo;Drug: TocilizumabHoffmann-La RocheNot recruiting18 YearsN/AAll212Phase 3Bulgaria;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
77EUCTR2015-000392-28-GB10/11/201528 February 2019A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA 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-ILDPatients 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 LimitedNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;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
78EUCTR2015-000392-28-NL02/11/20153 April 2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA 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-ILDPatients 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 bvAuthorisedFemale: yes
Male: yes
750Phase 3Portugal;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
79EUCTR2015-000424-28-DE02/11/201528 February 2019A 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 SCLEROSISSystemic 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 LtdNot Recruiting Female: yes
Male: yes
210Phase 3United 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
80NCT03531216November 2, 201521 January 2019Topical Rosemary Oil Application in Systemic SclerosisPsychophysiological Effect of Local Rosemary and Olive Oil Application Onto the Hands of Patients With Systemic Sclerosis - a Prospective Crossover, Open-label, Nonrandomized TrialSystemic SclerosisOther: Rosemary essential oil;Other: PlaceboARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity Hospital TuebingenNot recruiting18 YearsN/AAll12N/AGermany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
81NCT02503644October 29, 201518 March 2019Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic SclerosisScleroderma, Diffuse;Diffuse Cutaneous Systemic SclerosisDrug: IVA337;Drug: PlaceboInventiva PharmaNot recruiting18 Years75 YearsAll145Phase 2Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom
82JPRN-UMIN0000203892015/10/0122 July 2019Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHDClinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHDThe 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 dermatologyNot Recruiting20years-oldNot applicableMale and Female5Not selectedJapan
83EUCTR2015-001617-27-IT18/09/201526 February 2018A 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 POCSystemic 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 SASAuthorisedFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy
84EUCTR2014-005323-27-GB16/09/201528 February 2019A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosisA 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 MichiganNot Recruiting Female: yes
Male: yes
86Phase 2United States;Canada;Italy;United Kingdom
85EUCTR2015-001617-27-ES08/09/20154 December 2018A 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 POCSystemic 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 SASNot RecruitingFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
86EUCTR2015-000424-28-BE07/09/201528 February 2019A 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 SCLEROSISSystemic 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 LtdNot Recruiting Female: yes
Male: yes
210Phase 3United 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
87NCT02551042September 201513 June 2016CSL Behring Sclero XIIIA Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic SclerosisSystemic SclerosisDrug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chlorideUniversity College, LondonCSL BehringRecruiting18 YearsN/ABoth26Phase 2United Kingdom
88NCT02558543September 201518 March 2019Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic SclerosisSubcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy AssessmentScleroderma, SystemicDrug: Stromal Vascular fraction;Drug: Ringer lactateAssistance Publique Hopitaux De MarseilleNot recruiting18 YearsN/AAll40Phase 2France
89NCT02465437August 20159 October 2018Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic SclerosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: JBT-101;Drug: Placebo;Drug: Part B Open-Label ExtensionCorbus Pharmaceuticals Inc.Not recruiting18 Years70 YearsAll42Phase 2United States
90JPRN-UMIN0000183762015/07/2223 April 2019Efficacy and safety of rituximab for patients with severe rheumatic diseaseEfficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic diseaseChildhood-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 PediatricsNot Recruiting2years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
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agemin
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agemax
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PhaseCountries
91NCT02480335June 26, 201518 December 2018The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic SclerosisThe Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital UlcersScleroderma, SystemicDrug: bosentanUniversity Medical Center GroningenActelionNot recruiting18 YearsN/AAll20Phase 4Netherlands
92NCT02349009June 201516 December 2017Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialA Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety TrialSystemic SclerodermaDrug: C-82 Topical Gel, 1%;Drug: C-82 Topical Gel, PlaceboPrism Pharma Co., Ltd.Not recruiting18 YearsN/AAll17Phase 1/Phase 2United States
93NCT03692299June 201526 August 2019Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic SclerosisEfectividad de Saccharomyces Oulardii Para Reducir Los síntomas Gastrointestinales y Evitar el Sobrecrecimiento Bacteriano en Esclerosis sistémicaSystemic Sclerosis;Small Intestinal Bacterial OvergrowthDrug: Metronidazole;Drug: Saccharomyces Boulardii Oral TabletCoordinación de Investigación en Salud, MexicoNot recruiting18 Years65 YearsAll39Phase 4Mexico
94EUCTR2014-001353-16-GB17/04/201529 May 2017Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
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 AGAuthorisedFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
95NCT02356809March 201519 February 2015Safety and Efficacy Study of Gene Therapy Drug (Neovasculgen) to Treat Secondary Raynaud's PhenomenonSafety and Efficacy Study of Pl-vegf165 to Treat Secondary Raynaud's Phenomenon Caused by Systemic SclerodermaSecondary Raynaud's PhenomenonDrug: NeovasculgenHuman Stem Cell Institute, RussiaInstitute of Rheumatology-Russian Academy of Medical SciencesNot recruiting18 Years65 YearsBoth30Phase 1/Phase 2Russian Federation
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02370784February 201518 March 2019Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse SclerodermaThe Effect of Atorvastatin on Microvascular Endothelial Function and Raynaud in Early Diffuse Systemic SclerosisSclerodermaDrug: atorvastatin;Drug: PlaceboRobyn T. Domsic, MD, MPHNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years70 YearsAll30Phase 2United States
97NCT02283762January 15, 201523 April 2019Efficacy and Safety of Riociguat in Patients With Systemic SclerosisA 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, SystemicDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNot recruiting18 YearsN/AAll121Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain
98NCT02290613December 201416 December 2017Early 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 EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineNot recruiting18 YearsN/AAll38Phase 2Germany
99NCT02363478December 201419 October 2017Long 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 SclerosisDrug: buspironeLaikon General District Hospital, AthensNot recruiting18 Years75 YearsAll22Early Phase 1Greece
100JPRN-UMIN0000176172014/11/012 April 2019Effect of botulinum toxin A on Raynaud's phenomenon in patients with systemic sclerosisRaynaud's phenomenonBotulinum toxin A injectionGunma University HospitalNot Recruiting18years-oldNot applicableMale and Female10Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
101NCT02228850November 201411 April 2016Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic SclerosisA 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 SclerosisDrug: Alprostadil;Other: PlaceboNexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)Not recruiting18 Years79 YearsBoth35Phase 2United States
102EUCTR2014-000865-34-DE31/10/201414 March 2016A study to assess efficacy and safety of selexipag in subjects with Raynaud's Phenomenon secondary to Systemic SclerosisA 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 SclerosisRaynaud'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 LtdNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom
103EUCTR2014-001882-28-DE13/10/20148 January 2018Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITASystemic 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 gGmbHNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
104NCT02260557October 201423 May 2016Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic SclerosisA 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 SclerosisRaynaud's Phenomenon Secondary to Systemic SclerosisDrug: Selexipag;Drug: PlaceboActelionNot recruiting18 YearsN/ABoth74Phase 2France;Germany;United Kingdom
105NCT02161406September 201412 November 2018A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic SclerosisA 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 SclerosisDrug: Abatacept;Drug: PlaceboDinesh Khanna, MD, MSBristol-Myers Squibb;National Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 YearsN/AAll88Phase 2United States;Canada;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
106NCT02166229June 201422 August 2016Divalproex Sodium in the Treatment of the Cutaneous Manifestations of SclerodermaScleroderma;Systemic SclerosisDrug: Divalproex sodiumYale UniversityNot recruiting18 YearsN/ABoth0Phase 1/Phase 2United States
107NCT02213705June 201425 April 2016Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsTreatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem CellsSYSTEMIC SCLERODERMA;ALLOGENEIC MESENCHYMAL STEM CELLS;ADULTBiological: INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLSAssistance Publique - Hôpitaux de ParisRecruiting18 Years70 YearsBoth20Phase 1/Phase 2France
108NCT02212249May 201411 April 2016Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic SclerosisSoluble VE-cadherin and VE-cadherin Antibody in Sclerodermic SclerosisPrimary Raynaud Disease;Systemic SclerosisBiological: soluble Ve cadherinUniversity Hospital, GrenobleNot recruiting18 YearsN/ABoth85N/AFrance
109JPRN-UMIN0000154952014/04/0121 May 2019Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapiesOsaka UniversityNot Recruiting20years-old80years-oldMale and Female5Not applicableJapan
110EUCTR2013-004596-12-IT22/01/201419 February 2018Infusion 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. - iloportaRaynaud'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 RiunitiAuthorisedFemale: yes
Male: yes
20Phase 2Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
111NCT01988506January 6, 201427 August 2018Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid 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 SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaRecruiting18 YearsN/AAll132Phase 2France
112JPRN-jRCTs03118037012/11/201322 July 2019Clinical trial of tocilizumab for skin fibrosis in systemic sclerosisClinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosisSystemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six monthsAyumi YoshizakiShinichi SatoNot Recruiting>=20 age old<80 age oldBoth5Phase 2none
113JPRN-UMIN0000122142013/11/052 April 2019Clinical trial of tocilizumab for skin fobrosis in systemic sclerosisSystemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
The University of TokyoNot Recruiting20years-old80years-oldMale and Female5Not applicableJapan
114EUCTR2013-001353-28-IT04/10/201310 July 2015An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis-Related Interstitial Lung DiseaseAn Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone when Administered to Patients with Systemic Sclerosis-Related Interstitial Lung Disease - LOTUSSSystemic 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 RecruitingFemale: yes
Male: yes
50Phase 2United States;Canada;Italy
115NCT01933334October 201319 October 2017Safety 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 SclerosisDrug: PirfenidoneGenentech, Inc.Not recruiting18 Years75 YearsAll63Phase 2United States;Canada;Italy
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
116EUCTR2012-004955-35-IT29/07/201317 August 2015A 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 GEMELLIAuthorisedFemale: yes
Male: yes
Italy
117JPRN-JapicCTI-13217601/6/20132 April 2019Bosentan DUA prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc)Digital ulcers associated with systemic sclerosisIntervention name : Ro47-0203 / ACT-050088
INN of the intervention : Bosentan
Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5.
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.18BOTH20Phase 3
118NCT01878526June 201316 December 2017Gastroesophageal Reflux Treatment in SclerodermaThe Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic SclerosisGastroesophageal Reflux Disease;Systemic Sclerosis;SclerodermaDrug: Alginic acid;Drug: placebo (for domperidone);Drug: Domperidone;Drug: placebo (of alginic acid)Khon Kaen UniversityNot recruiting18 Years65 YearsAll80Phase 3Thailand
119NCT01804959May 201317 September 2018Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseA Proof-of-concept Double-blind Randomized Placebo-controlled Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal DiseaseSystemic SclerosisDietary Supplement: Vivomixx probioticsSingapore General HospitalNot recruiting18 YearsN/AAll40Phase 2Singapore
120NCT03561233May 20132 July 2018Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic SclerosisPrevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic SclerosisSystemic Sclerosis;Gastroesophageal Reflux;Proton Pubm InhibitorDrug: Omeprazole 20mgKhon Kaen UniversityThai Rheumatism AssociationNot recruiting18 YearsN/AAll250Phase 1
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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PhaseCountries
121NCT01748084April 9, 201311 June 2018Rituximab in Systemic SclerosisEvaluation of Rituximab in Systemic Sclerosis Associated PolyarthritisSystemic SclerosisDrug: Rituximab;Drug: Placebo (NaCl)Assistance Publique - Hôpitaux de ParisNot recruiting18 Years80 YearsAll22Phase 2/Phase 3France
122NCT01785056April 201323 July 2018IVIG Treatment in Systemic SclerosisA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic SclerosisSystemic Sclerosis;Diffuse SclerodermaBiological: PrivigenGeorgetown UniversityCSL BehringNot recruiting18 YearsN/AAll14N/AUnited States
123EUCTR2012-005348-92-IT19/02/201315 July 2013PROGASS PRucalopride On the GAstreonteric transit in Systemic SclerosisPROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis - PROGASSSysemic 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 MILANOAuthorisedFemale: yes
Male: no
Italy
124NCT01570764January 14, 20134 November 2019Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung DiseaseIntravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung FibrosisDrug: Cyclophosphamide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisHôpital Claude-HuriezNot recruiting18 YearsN/AAll40Phase 3France
125EUCTR2012-001369-34-GB26/10/201225 March 2013Proof of biological activity of SAR100842 in Systemic SclerosisDouble-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 SclerosisSystemic 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 & développementAuthorisedFemale: yes
Male: yes
30United States;Canada;Germany;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
126NCT01895244September 201229 April 2019Autologous Stem Cell Transplantation for Progressive Systemic SclerosisHighdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to ManifestationScleroderma;Cardiac Involvement;Autologous Stem Cell TransplantationDrug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cellsUniversity Hospital TuebingenRecruiting18 Years65 YearsAll44Phase 2Germany
127NCT01670565August 201216 December 2017Belimumab for the Treatment of Diffuse Cutaneous Systemic SclerosisBelimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.Systemic SclerosisDrug: BelimumabHospital for Special Surgery, New YorkHuman Genome Sciences Inc.Not recruiting18 YearsN/AAll20Phase 2United States
128JPRN-jRCTs03118037314/05/201222 July 2019Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosisClinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis - Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosisInterstitial lung disease secondary to systemic sclerosisRituximab 375mg/m2 once a week/4 timesAyumi YoshizakiShinichi SatoRecruiting20 age old80 age oldBoth60Phase 2none
129JPRN-UMIN0000077022012/04/262 April 2019Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosisInterstitial lung disease secondary to systemic sclerosisRituximab(+)
30weeks
375mg/m2
once a week
4 times
Department of Dermatology, University of TokyoRecruiting20years-old80years-oldMale and Female20Not selectedJapan
130EUCTR2011-002434-40-DE23/03/201217 July 2012Transplantation of stem cells for the treatment of svere systemic sclerosis with a protocol which is adapted to individual manifestatons of the diseaseHighdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosis Modification according to manifestation - AST-MOMASystemic 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 TuebingenAuthorisedFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
131EUCTR2010-023047-15-DE15/03/20123 April 2017A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Diseasesystemic 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 CorporationNot RecruitingFemale: yes
Male: yes
88Phase 2Sweden;Switzerland;United Kingdom;Italy;Germany;Russian Federation;Australia;Spain;Poland;United States;France
132NCT02562079March 201216 December 2017Vasculopathy, Inflammation and Systemic SclerosisVasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte ActivationSystemic SclerosisBiological: Blood samples;Biological: BiopsyUniversity Hospital, BordeauxSociété Française de RhumatologieNot recruiting18 Years75 YearsAll350N/AFrance
133NCT01497743February 20129 January 2017Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic SclerosisProbiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic SclerosisSclerodermaDrug: LactobacillusUniversity of MichiganNot recruiting18 YearsN/ABoth0Phase 4United States
134EUCTR2011-001460-22-GB19/01/20122 June 2014A 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/ASystemic 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.AuthorisedFemale: yes
Male: yes
86Phase 2/3France;United States;Canada;Germany;United Kingdom
135EUCTR2010-022969-95-GB21/12/201117 December 2012A 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 scLerosisIschemic 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 LtdAuthorisedFemale: yes
Male: yes
295Portugal;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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
136NCT01538719December 201111 June 2018IL1-TRAP, Rilonacept, in Systemic SclerosisRandomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker TrialScleroderma;Systemic Sclerosis;Diffuse Scleroderma;Diffuse Systemic SclerosisDrug: Rilonacept;Other: PlaceboBoston UniversityRegeneron PharmaceuticalsNot recruiting18 YearsN/AAll24Phase 1/Phase 2United States
137NCT01413100September 15, 201126 August 2019Scleroderma Treatment With Autologous Transplant (STAT) StudyA 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 SclerosisSystemic SclerodermaBiological: 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 AdministrationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)RecruitingN/A70 YearsAll30Phase 2United States;Canada
138NCT01445821September 201126 August 2019Autologous Stem Cell Systemic Sclerosis Immune Suppression TrialRandomized 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, SystemicBiological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: FludarabineNorthwestern UniversityNot recruiting17 Years60 YearsAll80Phase 3United States
139EUCTR2011-001667-44-SE28/06/201127 October 2014An 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 ABNot RecruitingFemale: yes
Male: yes
20Sweden;Switzerland;Germany
140NCT01086540June 24, 201126 August 2019Rituximab 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 PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years75 YearsAll58Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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agemin
Inclusion_
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PhaseCountries
141EUCTR2010-022710-77-DE16/06/201127 October 2014A 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 scLerosisIschemic 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 LtdNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
142JPRN-UMIN0000055502011/06/012 April 2019Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosisSystemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of MedicineRheumatology Keio University, Rheumatology Tokyo Women's Medical University, Dermatology Osaka UniversityNot Recruiting20years-old65years-oldMale and Female24Phase 2Japan
143NCT01257802May 201116 December 2017GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesGnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesLupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial DiffuseDrug: depot leuprolide acetate 3.75 mg;Drug: PlaceboJoseph MccuneNational Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting18 Years40 YearsFemale14Phase 3United States
144NCT01347008April 201119 October 2017Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic SclerosisEffect 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 TrialScleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud PhenomenonDrug: Sildenafil citrate;Drug: Placebo (Sugar pill)Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloNot recruiting18 YearsN/AFemale41Phase 3Brazil
145NCT01639573April 201121 January 2019Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic SclerosisCampath-1h as Immunoablative Therapy for Children and Adolescents With Treatment Refractory Systemic SclerosisSclerodermaDrug: CampathChildren's Hospital Los AngelesNot recruiting8 Years18 YearsAll0Phase 3United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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Inclusion_
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Inclusion_
gender
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size
PhaseCountries
146EUCTR2010-024005-13-GB11/03/201125 September 2012A 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 - ReinoRaynaud'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 PharmaNot RecruitingFemale: yes
Male: yes
United Kingdom
147NCT01309997March 201119 October 2017Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host DiseaseA Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell TransplantationGraft Versus Host Disease;Systemic SclerodermaDrug: imatinib mesylate;Biological: rituximabLee, StephanieNational Cancer Institute (NCI)Not recruiting2 YearsN/AAll72Phase 2United States
148NCT01315899March 201119 February 2015Efficacy of ORM-12741 for Prevention of Raynaud's PhenomenonPhase 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 SclerosisRaynaud's PhenomenonDrug: ORM-12471 30mg;Drug: ORM-12471;Drug: placeboOrion Corporation, Orion PharmaNot recruiting18 Years75 YearsBoth15Phase 2United Kingdom
149NCT01395732March 201119 February 2015Bosentan in Systemic SclerosisEffects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the HandsSystemic Sclerosis;Digital UlcersDrug: BosentanActelionNot recruiting18 YearsN/ABoth18Phase 4Netherlands
150NCT01284322January 201119 February 2015Fresolimumab In Systemic SclerosisOPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIALDiffuse Systemic SclerosisDrug: FresolimumabBoston UniversityNot recruiting18 YearsN/ABoth18Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Inclusion_
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PhaseCountries
151EUCTR2010-019977-14-IT04/11/201019 March 2012Efficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - NDEfficacy of Cilostazol for the treatment of Raynaud’s Phenomenon in patients affected by Systemic Sclerosis - NDPatients 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 GENOVAAuthorisedFemale: yes
Male: yes
Italy
152EUCTR2009-018194-31-GB03/11/201019 March 2012Topical Amlodipine in Raynaud's PhenomenonTopical Amlodipine in Raynaud's PhenomenonThe 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 LimitedAuthorisedFemale: yes
Male: yes
45United Kingdom
153NCT01295736November 201019 February 2015Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDYEvaluation 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 StudySystemic SclerodermaDrug: Sildenafil;Drug: placeboUniversity Hospital, LilleNot recruiting18 YearsN/ABoth84Phase 3France
154EUCTR2009-013468-37-GB29/09/201019 March 2012A 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 phenomenonA 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 phenomenonPrimary 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 DiseaseAuthorisedFemale: yes
Male: yes
United Kingdom
155EUCTR2009-017869-27-DE23/09/201019 March 2012A 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 ZurichAuthorisedFemale: yes
Male: yes
14Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
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PhaseCountries
156JPRN-UMIN0000319402010/09/072 April 2019Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosisSystemic sclerosisCyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
Kyushu UniversityNot Recruiting16years-old65years-oldMale and Female24Phase 2Japan
157JPRN-UMIN0000041622010/09/012 April 2019The efficacy of Mizoribine for scleroderma of systemic sclerosis.systemic sclerosisa group of Mizoribine
a group of the existing treatment
Faculty of Life Sciences, Kumamoto UniversityRecruitingNot applicableNot applicableMale and Female10Not selectedJapan
158NCT01166139July 201016 December 2017Nilotinib in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Nilotinib in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Nilotinib (Tasigna)Hospital for Special Surgery, New YorkRudolph Rupert Scleroderma Program;Novartis PharmaceuticalsNot recruiting18 YearsN/AAll10Phase 2United States
159NCT02339441June 201023 May 2016Treatment Outcome in Early Diffuse Cutaneous Systemic SclerosisTreatment Outcome in Early Diffuse Cutaneous Systemic SclerosisEarly Diffuse Cutaneous Systemic SclerosisDrug: Methotrexate;Drug: Mycophenolate mofetil;Drug: CyclophosphamideUniversity of ManchesterNot recruiting18 YearsN/ABoth320N/A
160NCT01151644April 201019 February 2015Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid 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 DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloNot recruitingN/AN/ABoth5000Phase 4Brazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
161NCT01072669February 201019 October 2017Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or FeetEvaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion ImagingIschemiaDrug: ambrisentanSoumya ChatterjeeGilead SciencesNot recruiting18 Years70 YearsAll20N/AUnited States
162NCT01093885February 201010 December 2018Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic SclerosisAn Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic SclerosisSystemic Sclerosis;SclerodermaDrug: AmbrisentanUniversity of PennsylvaniaGilead SciencesNot recruiting19 Years90 YearsAll15N/AUnited States
163NCT01042158January 201016 December 2017A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityNot recruiting18 YearsN/AAll25Phase 4United States
164NCT01047072January 201019 February 2015Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic SclerosisPhase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic SclerodermaDrug: 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 transplantationFred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumNational Cancer Institute (NCI)Not recruiting18 Years65 YearsBoth0Phase 2United States
165NCT01586663January 201019 February 2015Serial Night Time Position Splint on Systemic SclerosisEvaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic SclerosisDiffuse Systemic SclerosisDevice: Serial night time position splint;Drug: Drug treatmentFederal University of São PauloRecruiting18 YearsN/ABoth76Phase 3Brazil
No.TrialIDDate_
enrollement
Last_Refreshed_
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agemin
Inclusion_
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Inclusion_
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Target_
size
PhaseCountries
166NCT00848107September 200919 October 2017Open-Label Study of Oral Treprostinil in Digital UlcersDigital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: An Open-label Multicenter Extension StudySystemic SclerosisDrug: treprostinil diethanolamineUnited TherapeuticsNot recruiting18 YearsN/AAll115Phase 2United States;Canada;United Kingdom
167NCT00962923August 200919 February 2015Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)Systemic Sclerosis;Mesenchymal Stem CellsBiological: Allogeneic Mesenchymal Stem Cells (AlloMSC)The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting15 Years65 YearsBoth20Phase 1/Phase 2China
168EUCTR2008-007180-16-NL13/05/200919 March 2012INFLUENCE 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
LUMCAuthorisedFemale: yes
Male: yes
Netherlands
169NCT00775463May 200919 October 2017Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil DiethanolamineDISTOL-1: Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine: A Randomized, Double-blind, Placebo-controlled, Multicenter StudySystemic Sclerosis;SclerodermaDrug: treprostinil diethanolamine;Drug: placeboUnited TherapeuticsNot recruiting18 YearsN/AAll148Phase 2United States;Canada;United Kingdom
170EUCTR2008-005018-39-GB05/03/200919 March 2012DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1DISTOL-1:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: A randomized, double-blind, placebo controlled, multicenter study - DISTOL-1Systemic 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 CorporationNot RecruitingFemale: yes
Male: yes
150United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2008-006978-15-GB05/03/200919 March 2012DISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXTDISTOL-EXT:Digital Ischaemic Lesions in Scleroderma treated with Oral Treprostinil Diethanolamine: An open-label multicenter extension study - DISTOL-EXTSystemic 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 CorporationNot RecruitingFemale: yes
Male: yes
450United Kingdom;Canada;United States
172NCT01051960March 200911 June 2018Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With AmbrisentanExercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot StudySystemic Sclerosis;Shortness of Breath;Pulmonary HypertensionDrug: AmbrisentanUniversity of California, Los AngelesGilead SciencesNot recruiting18 Years80 YearsAll15Phase 4United States
173NCT00769028December 200819 February 2015AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisA Double-Blind Placebo-Controlled Pilot Study of Safety and Tolerability of AIMSPRO in Established Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: Hyperimmune caprine serum;Drug: AlbuminDaval International LimitedNot recruiting18 YearsN/ABoth20Phase 2United Kingdom
174NCT00848939December 200819 February 2015Pharmacokinetics of Oral Treprostinil in Patients With Systemic SclerosisAn Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic SclerosisSystemic SclerosisDrug: treprostinil diethanolamineUnited TherapeuticsNot recruiting18 YearsN/ABoth28Phase 1United States
175NCT00442611November 200816 December 2017A 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 SclerosisScleroderma, Diffuse;Scleroderma, SystemicDrug: Abatacept;Drug: PlaceboStanford UniversityBristol-Myers SquibbNot recruiting18 YearsN/AAll10Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2006-004598-83-GB22/10/200819 March 2012High 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) - ASTISHigh 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) - ASTISSevere 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)AuthorisedFemale: yes
Male: yes
150United Kingdom
177EUCTR2008-000224-27-GB15/10/200819 March 2012Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung diseaseSystemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung diseaseSystemic 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 TrustAuthorisedFemale: yes
Male: yes
United Kingdom
178NCT00984932September 200819 February 2015Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary HypertensionThe Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled TrialSystemic SclerosisDrug: RosuvastatinFaculty of Medicine, University of AlexandriaNot recruitingN/AN/ABoth40Phase 3Egypt
179EUCTR2005-003775-21-GB14/08/200819 March 2012Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosisEffects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosisSystemic 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 TrustUniversity of ManchesterAuthorisedFemale: yes
Male: yes
36United Kingdom
180EUCTR2008-001265-28-ES17/06/200819 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” - OLEFibrosis 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%-
ISDINAuthorisedFemale: yes
Male: yes
98Hungary;United Kingdom;Germany;Spain;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00725361June 200816 December 2017A 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, SystemicDrug: AmbrisentanStanford UniversityNot recruiting18 YearsN/AAll20N/AUnited States
182EUCTR2007-003621-24-FR29/05/200819 March 2012Double-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 AGAuthorisedFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
183EUCTR2007-003122-24-GB09/04/200819 March 2012A 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 sclerosisA 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 sclerosisDiffuse 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 LimitedAuthorisedFemale: yes
Male: yes
United Kingdom
184EUCTR2007-004669-17-GB15/02/200819 March 2012A 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 sclerosisA 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 sclerosisSkin 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 AGNot RecruitingFemale: yes
Male: yes
27United Kingdom;Italy
185NCT00613171January 200822 October 2018Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic SclerosisA Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic SclerosisSystemic Sclerosis, SclerodermaDrug: STI571Novartis PharmaceuticalsNot recruiting18 YearsN/AAll27Phase 2United States;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
186NCT00909337January 200819 February 2015Early Therapy of Pulmonary Arterial HypertensionEarly Therapy of Pulmonary Arterial HypertensionPulmonary Hypertension;Systemic SclerosisDrug: BosentanMedical University of GrazActelionNot recruiting18 Years90 YearsBoth10N/AAustria
187NCT00479934December 200719 February 2015Efficacy and Safety of Imatinib in SclerodermaPhase 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, SystemicDrug: imatinib mesylateUniversity Hospital, BordeauxMinistry of Health, France;NovartisNot recruiting18 YearsN/ABoth28Phase 2France
188NCT00581997December 200719 February 2015QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic SclerosisA 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 SclerosisPulmonary Fibrosis Secondary to Systemic SclerosisDrug: QAX576;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years65 YearsBoth8Phase 2United States
189EUCTR2007-006035-32-IT15/11/200719 March 2012Assessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - NDAssessment of endothelial function and vasal response in patients with Systemic Sclerosis and Hypercholesterolemia, before and after simvastatin treatment. - NDSystemic 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 PISANANot RecruitingFemale: yes
Male: yes
Italy
190EUCTR2007-005322-68-IT30/10/200719 March 2012Low-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in sclerodermaLow-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in sclerodermaSystemic 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.SALESIAuthorisedFemale: yes
Male: yes
Phase 2Italy
No.TrialIDDate_
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Last_Refreshed_
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191EUCTR2007-002015-38-HU04/09/200729 May 2012Phase 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)
ISDINNot RecruitingFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
192EUCTR2006-007091-15-NL03/09/200719 March 2012Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosisGlivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosissystemic sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma
Product Name: Glivec
Pharmaceutical Form: Capsule*
ErasmusMCAuthorisedFemale: yes
Male: yes
10Netherlands
193EUCTR2007-002015-38-ES23/08/200729 May 2012ENSAYO 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 SCLEROSISENSAYO 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 SCLEROSISFIBROSIS 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)
ISDINAuthorisedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
194NCT00512902August 200719 October 2017A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic SclerosisPilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic SclerosisAlveolitis;Systemic SclerosisDrug: ImatinibUniversity of California, Los AngelesNovartis PharmaceuticalsNot recruiting18 YearsN/AAll20Phase 1/Phase 2United States
195NCT00555581August 200719 February 2015Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Imatinib MesylateHospital for Special Surgery, New YorkNovartis PharmaceuticalsNot recruiting18 YearsN/ABoth30Phase 2United States
No.TrialIDDate_
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196NCT00684255August 200719 October 2017Reduced 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 SclerosisProcedure: Reduced Intensity Allogeneic Transplant;Drug: Fludarabine;Drug: Busulfan;Drug: CampathNew York Medical CollegeNot recruiting7 Years50 YearsAll1Phase 1United States
197NCT00506831July 200720 August 2018Imatinib in Systemic SclerosisA Pilot Study of Imatinib in the Treatment of Refractory Systemic SclerosisScleroderma, SystemicDrug: Imatinib mesylateStanford UniversityNot recruiting18 Years80 YearsAll9Phase 1/Phase 2United States
198NCT00463125March 200719 February 2015Platelet Gel in Systemic SclerosisPlatelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled TrialScleroderma, SystemicDrug: Platelet GelUniversità Politecnica delle MarcheRecruiting18 Years80 YearsBoth40Phase 2/Phase 3Italy
199NCT00428883January 200719 February 2015High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic SclerosisRare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic SclerosisScleroderma, DiffuseDrug: N-acetylcysteine (NAC)Università Politecnica delle MarcheRecruiting18 Years80 YearsBoth45Phase 2/Phase 3Italy
200NCT00379431November 200619 February 2015A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), RituximabA Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), RituximabEarly and Severe Systemic SclerosisDrug: Administration of rituximab and methylprednisoloneUniversity Hospital, GhentNot recruiting18 YearsN/ABoth40Phase 2Belgium
No.TrialIDDate_
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201EUCTR2006-002081-19-NL16/10/200619 March 2012The 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-PAHThe 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-PAHPulmonary arterial hypertension associated with systemic sclerosisTrade Name: Erbitux
Product Name: Cetuximab
Product Code: C225
Pharmaceutical Form: Intravenous infusion
VU University Medical CentreAuthorisedFemale: yes
Male: yes
20Phase 2Netherlands
202EUCTR2006-003957-25-IT13/10/200619 March 2012Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidly progressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SScRare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidly progressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SScSystemic 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.SALESIAuthorisedFemale: yes
Male: yes
Italy
203EUCTR2006-003836-31-BE06/09/20067 October 2014A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximabA protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximabsystemic 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 GentAuthorisedFemale: yes
Male: yes
Belgium
204NCT00622895September 1, 200611 June 2018Allogeneic Hematopoietic Cell Transplantation for Severe Systemic SclerosisAllogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic Scleroderma;Severe Systemic SclerosisDrug: 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: biopsyFred Hutchinson Cancer Research CenterNational Institute of Allergy and Infectious Diseases (NIAID)Not recruitingN/A70 YearsAll3Phase 1/Phase 2United States
205NCT00377455September 200611 June 2018Placebo Controlled Trial of Bosentan in Scleroderma PatientsPlacebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary HypertensionSystemic Scleroderma;Pulmonary HypertensionDrug: Bosentan;Drug: PlaceboGeorgetown UniversityActelionNot recruiting18 YearsN/AAll5Phase 2United States
No.TrialIDDate_
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206EUCTR2006-005230-20-IT14/07/200612 November 2012EX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS. Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica - NDEX VIVO EFFECT OF AMINAFTONE (CAPILLAREMA) ON THE ENDOTELIAL FUNCTION IN SYSTEMIC SCLEROSIS. Effetto ex vivo dell’aminaftone (Capillarema) sulla funzione endoteliale nella Sclerosi Sistemica - NDVariazione 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)AuthorisedFemale: yes
Male: yes
Italy
207NCT00348296July 200619 February 2015Efficacy and Safety Study of GB-0998 for Treatment of Systemic SclerosisA Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic SclerosisScleroderma, SystemicDrug: High-dose intravenous immunoglobulin (Venoglobulin-IH)Benesis CorporationNot recruiting16 YearsN/ABoth60Phase 3Japan
208EUCTR2006-000905-41-AT07/06/20067 November 2016Offene, 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 raynaudOffene, 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 raynaudRaynaud syndrome with / without systemic sclerosisTrade 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 AbererNot RecruitingFemale: yes
Male: yes
Phase 4Austria
209NCT00318175June 200619 February 2015Effect of Bosentan on Skin Fibrosis in Patients With Systemic SclerosisStudy to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF)Systemic Scleroderma;Skin Fibrosis;Hand FunctionalityDrug: Bosentan (Tracleer)Heinrich-Heine University, DuesseldorfNot recruiting18 YearsN/ABoth10Phase 2Germany
210NCT00433186March 200619 February 2015Mycophenolate Mofetil in Systemic SclerosisPhase I, Open-label Study of Mycophenolate Mofetil In Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Mycophenolate MofetilBoston UniversityAspreva PharmaceuticalsNot recruiting18 YearsN/ABoth30Phase 1United States
No.TrialIDDate_
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211NCT00278525September 200519 October 2017Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic SclerodermaTrial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized TrialSYSTEMIC SCLERODERMADrug: standard of care;Procedure: stem cell transplantationNorthwestern UniversityNot recruitingN/A60 YearsAll19Phase 2United States
212NCT00114530June 200516 December 2017Scleroderma: 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 DiseaseBiological: mHSCT;Drug: cyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)Not recruiting18 Years69 YearsAll75Phase 2/Phase 3United States;Canada
213NCT00282425May 200519 February 2015Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisNon-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisSclerodermaBiological: Hematopoietic stem cell transplantationRichard Burt, MDNot recruiting18 Years55 YearsBoth8Phase 1United States
214EUCTR2004-000632-82-IT06/04/200519 March 2012Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcersLong term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcersHealing 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 ITALIANot RecruitingFemale: yes
Male: yes
180Italy
215JPRN-UMIN0000207012005/03/102 April 2019The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic sclerodermaThe 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 sclerodermareflux esophagitis associated with systemic sclerodermaRabeprazole 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 UniversityNot RecruitingNot applicableNot applicableMale and Female40Not applicableJapan
No.TrialIDDate_
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216NCT00226889January 200519 February 2015Treatment of Early Systemic Sclerosis by BosentanSystemic Sclerosis (Scleroderma)Drug: bosentanRikshospitalet University HospitalNot recruiting18 Years70 YearsBoth30Phase 1/Phase 2Norway
217EUCTR2004-000632-82-GB16/09/200417 October 2016Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extensionLong term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extensionSSc 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 diseaseTrade 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.AuthorisedFemale: yes
Male: yes
180Phase 3Italy;United Kingdom
218EUCTR2004-000631-28-IT14/09/200419 March 2012Bosentan 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 sclerosisTrade 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 ITALIANot RecruitingFemale: yes
Male: yes
Italy
219NCT00319033July 200411 May 2015Open-label Study With Bosentan in Interstitial Lung DiseaseLong-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.Interstitial Lung Disease;SclerodermaDrug: bosentanActelionNot recruiting18 YearsN/ABoth132Phase 2/Phase 3United States;Canada;France;Germany;Israel;Italy;Korea, Republic of;Netherlands;Sweden;Switzerland;United Kingdom
220NCT00319696July 200419 October 2017Bosentan in Digital UlcersLong-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital UlcersSystemic Sclerosis;Digital UlcersDrug: bosentanActelionNot recruiting18 YearsN/AAll116Phase 3United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
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221NCT00624273February 200419 February 2015Sildenafil for Treatment of Digital Ulcers in Patients With Systemic SclerosisEffect of Sildenafil on Digital Ulcers in Systemic SclerosisActive Digital UlcersDrug: Sildenafil therapyCharite University, Berlin, GermanyNot recruiting18 Years80 YearsBoth17Phase 2Germany
222NCT00077584October 20037 November 2016Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisDigital Ulcers;Systemic SclerosisDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNot recruiting18 YearsN/ABoth188Phase 3United States;Canada
223NCT02800993October 200327 June 2016Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisSystemic Sclerosis;Digital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNot recruiting18 YearsN/ABoth188Phase 3United States;Canada
224NCT00070590July 200319 February 2015Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With SclerodermaA 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 SclerosisPulmonary Fibrosis;Scleroderma, SystemicDrug: BosentanActelionNot recruiting18 YearsN/ABoth132Phase 2/Phase 3United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom
225NCT00241189August 200218 April 2016Rapamycin vs Methotrexate in Diffuse SScA 48-week, Double-blind, Randomized, Parallel Phase I/II Study of Oral Rapamycin Versus Methotrexate in Systemic Sclerosis (Scleroderma)Systemic SclerosisDrug: rapamycin;Drug: methotrexateUniversity of California, Los AngelesNot recruiting18 Years70 YearsBoth17Phase 1/Phase 2United States
No.TrialIDDate_
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226NCT00040651July 200219 February 2015Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma PatientsTransplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation StudyScleroderma;Systemic SclerosisDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Thymoglobulin;Procedure: Leukapheresis;Procedure: Self bone marrow transplantNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)University of Pittsburgh;Amgen;Genzyme, a Sanofi CompanyNot recruiting18 Years70 YearsBoth15Phase 1United States
227NCT00043706May 200216 March 2015Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic SclerosisA 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 SclerosisSystemic Sclerosis;SclerodermaDrug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal AntibodyGenzyme, a Sanofi CompanyCambridge Antibody TechnologyNot recruiting18 Years75 YearsBothPhase 1/Phase 2United States
228NCT00707187July 200119 February 2015Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual DysfunctionRandomized, 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 SclerosisSystemic SclerosisDrug: CialisUniversity of Medicine and Dentistry of New JerseyNot recruiting18 YearsN/AFemale120Phase 2United States
229NCT00501995February 200116 December 2017High Dose Cyclophosphamide for Treatment of SclerodermaHigh Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma)SclerodermaDrug: IV CyclophosphamideJohns Hopkins UniversityNot recruiting18 Years70 YearsAll6Phase 3United States
230NCT00418132August 200011 April 2016Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic SclerosisT Cell Immunity in Collagen Biosynthesis of SclerodermaScleroderma, SystemicDrug: Thalidomide;Drug: Placebo thalidomideNew York University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years65 YearsBoth30Phase 1United States
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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231NCT00016458June 200019 February 2015Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic SclerosisSystemic SclerosisDrug: anti-thymocyte globulin;Drug: cyclophosphamideFred Hutchinson Cancer Research CenterNot recruitingN/A64 YearsBoth20Phase 2United States
232NCT00004563August 199919 October 2017Scleroderma Lung DiseaseCyclophosphamide Versus Placebo in Scleroderma Lung StudyLung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, SystemicDrug: Cyclophosphamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 YearsN/AAll158Phase 3
233NCT00058578June 199919 February 2015Stem Cell Transplant to Treat Patients With Systemic SclerosisAutologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic SclerosisSystemic SclerosisDrug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body IrradiationBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineNot recruiting18 Years65 YearsBoth24Phase 1United States
234NCT00704665December 199819 February 2015Recombinant Human Relaxin in the Treatment of Diffuse SclerodermaA Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse SclerodermaSystemic SclerosisDrug: RelaxinUniversity of Medicine and Dentistry of New JerseyUniversity 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 WisconsinNot recruiting18 Years70 YearsBoth231Phase 3
235NCT00622687September 199719 February 2015Effect of Different Iloprost Doses on Symptoms in Systemic SclerosisComparision Between Maximally Tolerated Intravenous Iloprost Doses Versus Low-Dosed Iloprost for a 21-Day Treatment CourseSystemic SclerosisDrug: iloprost;Drug: iloprost low dose;Drug: iloprost therapy up to 2 ng/kg x minCharite University, Berlin, GermanySchering-PloughNot recruiting18 Years80 YearsBoth50Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT00004786December 199519 February 2015Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic SclerosisSystemic Sclerosis;Raynaud DiseaseDrug: iloprostNational Center for Research Resources (NCRR)University of PittsburghNot recruiting18 YearsN/ABoth200Phase 3
237NCT00004380December 199119 February 2015Phase II Study of Recombinant Relaxin for Progressive Systemic SclerosisSystemic SclerosisDrug: relaxinNational Center for Research Resources (NCRR)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Stanford UniversityNot recruitingN/AN/ABoth1Phase 2

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