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


臨床試験数 : 523 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03800017
(ClinicalTrials.gov)
September 1, 202221/11/2018Skeletal Muscle Function in Interstitial Lung DiseaseInvestigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung DiseaseInterstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Hypersensitivity Pneumonitis;Scleroderma;Nonspecific Interstitial PneumoniaBiological: HyperoxiaUniversity of British ColumbiaNULLNot yet recruiting40 Years80 YearsAll40N/ANULL
2NCT04432545
(ClinicalTrials.gov)
September 1, 202210/6/2020Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary InvolvementInfusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to TreatmentSystemic Sclerosis Pulmonary;Pulmonary Hypertension;Pulmonary FibrosisBiological: Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jellyUniversidad de la SabanaFundación Neumologica Colombiana;Stem Medicina Regenerativa;CryoHoldco LATAMAvailable18 Years65 YearsAllColombia
3NCT04356287
(ClinicalTrials.gov)
April 202215/4/2020Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic SclerosisPhase I/II Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic SclerosisSclerosis, Systemic;Mesenchymal Stem CellsBiological: UCMSC;Other: PlaceboMarie Hudson, MDAssistance Publique - Hôpitaux de Paris;University Paris 7 - Denis Diderot;Université de Montréal;Medical University of South Carolina;Centre hospitalier de l'Université de Montréal (CHUM);McGill University Health Centre/Research Institute of the McGill University Health CentreNot yet recruiting18 YearsN/AAll18Phase 1/Phase 2NULL
4NCT05214014
(ClinicalTrials.gov)
March 1, 202229/11/2021Treatment of Systemic Sclerosis With Autologous Regulatory ?-cellsTreatment of Patients With Systemic Sclerosis With Autologous Regulatory ?-cellsSystemic SclerosisBiological: Autologous Regulatory ?-cells;Other: Standard treatment according to the clinical protocolsInstitute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusBelarusian State Medical UniversityNot yet recruiting18 Years80 YearsAll30Phase 1/Phase 2NULL
5NCT04986605
(ClinicalTrials.gov)
March 20221/6/2021Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic SclerosisThe Effectiveness of ECP in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisOther: Extracorporeal Photopheresis (ECP) with MethoxsalenLawson Health Research InstituteMallinckrodtNot yet recruiting18 YearsN/AAll15Phase 2Canada
6NCT05198557
(ClinicalTrials.gov)
March 20226/1/2022A Study of MT-0551 in Patients With Systemic SclerosisPhase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)Systemic SclerosisDrug: Inebilizumab;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNULLNot yet recruiting20 Years80 YearsAll80Phase 3Japan
7NCT05236491
(ClinicalTrials.gov)
March 202210/2/2022COvid-19 Vaccine Booster in Immunocompromised Rheumatic DiseasesCOvid-19 Vaccine Booster in Immunocompromised Rheumatic DiseasesRheumatoid Arthritis;Autoimmune Rheumatologic Disease;Systemic Lupus Erythematosus;Systemic Vasculitis;Systemic Sclerosis;Scleroderma;Undifferentiated Connective Tissue Diseases;Overlap Connective Tissue Disease;ImmunosuppressionBiological: COVID-19 vaccinePaul R FortinCanadian Institutes of Health Research (CIHR)Not yet recruiting18 YearsN/AAll287Phase 2/Phase 3NULL
8NCT04380831
(ClinicalTrials.gov)
February 24, 202230/4/2020TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic SclerosisPilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic SclerosisSystemic SclerodermaProcedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body IrradiationCity of Hope Medical CenterNational Cancer Institute (NCI)Recruiting18 Years65 YearsAll15Early Phase 1United States
9NCT05270668
(ClinicalTrials.gov)
February 22, 202227/2/2022Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)Diffuse Cutaneous Systemic Sclerosis;Interstitial Lung DiseaseDrug: PRA023 IV;Device: Companion diagnostic ( CDx);Drug: PlaceboPrometheus Biosciences, Inc.PPDRecruiting18 YearsN/AAll100Phase 2United States
10JPRN-jRCT2031210521
15/02/202226/12/2021Phase 3 Study of MT-0551 in Patients with Systemic SclerosisPhase 3 Study of MT-0551 in Patients with Systemic Sclerosis (Placebo-Controlled Double-Blind Study) Systemic Sclerosis(1)MT-0551 group
Participants will receive intravenous (IV) inebilizumab on Day 1 and Day 15 of randomized controlled period (RCP). The participants who entered open label period (OLP) will receive IV inebilizumab on Day 1 and IV placebo on Day 15 of OLP and will be followed by IV inebilizumab every 26 weeks.
(2)Placebo group
Participants will receive IV placebo on Day 1 and Day 15 of the RCP. The participants who entered OLP will receive IV inebilizumab on both Day 1 and Day 15 in OLP and will be followed by IV inebilizumab every 26 weeks.
Kondou KazuokiNULLPending>= 20age old<= 80age oldBoth80Phase 3Japan
11NCT05214794
(ClinicalTrials.gov)
February 14, 202217/1/2022An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic SclerosisAn Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic SclerosisSystemic SclerosisDrug: nemolizumabMaruho Co., Ltd.NULLNot yet recruiting20 Years70 YearsAll8Phase 2Japan
12NCT05016804
(ClinicalTrials.gov)
February 202217/8/2021Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic SclerosisSafety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Systemic SclerosisSystemic SclerosisBiological: AlloRxThe Foundation for Orthopaedics and Regenerative MedicineNULLRecruitingN/AN/AAll20Phase 1Antigua and Barbuda
13EUCTR2020-005764-62-PL
(EUCTR)
31/01/202205/01/2022A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
14EUCTR2020-005764-62-NL
(EUCTR)
31/01/202225/11/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Netherlands;Germany;Japan;Korea, Republic of
15EUCTR2021-000230-33-IT
(EUCTR)
26/01/202217/08/2021TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE VERSUS PLACEBO IN EARLY SYSTEMIC SCLEROSIS (SSc)A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADD-ON TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE IN EARLY SYSTEMIC SCLEROSIS (SSc)- HYDROXYSSc - HYDROXYSSc Systemic Sclerosis (SSc) is a rare and orphan disease (DPCM 12 gennaio 2017-GU SG n°65-S.O. n°15 - 18/03/2017), characterized by immunological, vascular and fibrotic abnormalities. The estimated incidence is 18 to 20 cases per million population year and a prevalence of 100 to 300 cases per million population. In Europe the prevalence rate is estimated around 200 per million while in the Italian population around 20000 persons suffer from this form of autoimmune disease.
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Idrossiclorochina solfato
Product Code: [N/A]
INN or Proposed INN: idrossiclorochina solfato
UMBERTO I - POLICLINICO DI ROMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
151Phase 3Italy
16NCT04789850
(ClinicalTrials.gov)
January 202210/2/2021Safety and Efficacy of Itacitinib in Adults With Systemic SclerosisSafety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled TrialSystemic SclerosisDrug: Itacitinib;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting18 YearsN/AAll74Phase 2France
17JPRN-jRCT2031210481
12/12/202112/12/2021An Open-label, Phase 2 Study to Assess the Effecacy and Safety of Nemolizumab in Subjects with Systemic SclerosisAn Open-label, Phase 2 Study to Assess the Effecacy and Safety of Nemolizumab in Subjects with Systemic Sclerosis Systemic SclerosisNemolizumab will be administered subcutaneouslyNishiura TomoyukiNULLPending>= 20age old<= 70age oldBoth8Phase 2Japan
18NCT05029336
(ClinicalTrials.gov)
December 202124/8/2021Autologous Stem Cell Transplant (ASCT) for Autoimmune DiseasesAutologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune DiseasesSystemic Lupus Erythematosus;Systemic SclerosisBiological: Depletion of CD3/CD19 in an autologous stem cell transplantStephan Grupp MD PhDNULLRecruiting8 Years25 YearsAll20Phase 2United States
19NCT05098145
(ClinicalTrials.gov)
November 24, 202120/10/2021A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic SclerosisA Single-arm, Multi-center, Open-label Proof of Concept Safety and Efficacy Study of FCR001 Cell-based Therapy in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis at Risk for Organ FailureDiffuse Cutaneous Systemic SclerosisBiological: FCR001Talaris Therapeutics Inc.NULLRecruiting18 Years70 YearsAll18Phase 1/Phase 2United States
20NCT04478994
(ClinicalTrials.gov)
November 17, 202116/7/2020A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisBiological: TEPEZZA;Other: PlaceboHorizon Therapeutics USA, Inc.NULLRecruiting18 Years80 YearsAll25Phase 1United States
21NCT04915950
(ClinicalTrials.gov)
November 3, 20211/6/2021A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Subjects With Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud's Phenomenon Secondary to Systemic SclerosisDrug: Temanogrel;Drug: PlaceboArena PharmaceuticalsNULLRecruiting18 Years75 YearsAll48Phase 2United States;United Kingdom
22NCT04927390
(ClinicalTrials.gov)
November 1, 202119/5/2021Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)A Randomised Prospective Open Label Pilot Trial Comparing Mycophenolate Mofetil (MMF) With no Immunosuppression in Adults With Limited Cutaneous Systemic SclerosisSystemic Sclerosis;Limited Cutaneous Systemic SclerosisDrug: Mycophenolate Mofetil 500mgUniversity College, LondonVersus ArthritisNot yet recruiting18 YearsN/AAll120Phase 2United Kingdom
23NCT05085444
(ClinicalTrials.gov)
October 8, 202111/10/2021A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory SclerodermaA Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory SclerodermaScleroderma;Autoimmune DiseasesBiological: Assigned Interventions CD19/BCMA CAR T-cellsZhejiang UniversityYake Biotechnology Ltd.RecruitingN/AN/AAll9Early Phase 1China
24EUCTR2020-005764-62-IT
(EUCTR)
29/09/202130/08/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis - - Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: HZN-825
Product Code: [HZN-825]
HORIZON THERAPEUTICS IRELAND DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Greece;Spain;Korea, Democratic People's Republic of;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
25EUCTR2020-005116-21-PL
(EUCTR)
27/09/202125/06/2021FT011 for SclerodermaA phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma diffuse systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: FT011 100 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Product Name: FT011 200 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Certa Therapeutics Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Spain;Poland;Ukraine;Australia;Russian Federation;Netherlands
26NCT04797286
(ClinicalTrials.gov)
September 20, 202111/3/2021Sildenafil for Early Pulmonary Vascular Disease in SclerodermaSildenafil for Early Pulmonary Vascular Disease in SclerodermaScleroderma;Mildly Elevated Pulmonary PressuresDrug: Sildenafil;Other: PlaceboJohns Hopkins UniversityLouisiana State University Health Sciences Center in New OrleansRecruiting18 YearsN/AAll30Phase 2United States
27NCT04948554
(ClinicalTrials.gov)
September 16, 20214/6/2021Study of ACE-1334 to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy in Participants With Systemic Sclerosis With and Without Interstitial Lung DiseaseA Phase 1b/2 Open-Label, Multiple-Ascending Dose Study Followed by a Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis With and Without Interstitial Lung DiseaseSystemic Sclerosis With and Without Interstitial Lung DiseaseDrug: ACE-1334;Drug: PlaceboAcceleron Pharma Inc.NULLRecruiting18 YearsN/AAll210Phase 1/Phase 2United States
28EUCTR2020-000134-17-PL
(EUCTR)
14/09/202118/08/2021A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Dersimelagon
Product Code: MT-7117
INN or Proposed INN: Dersimelagon
Other descriptive name: MT-7117
Mitsubishi Tanabe Pharma Development America, Inc. (MTDA)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United Kingdom;Italy;Germany;Poland;Belgium;Spain;Canada;United States
29EUCTR2020-005764-62-GR
(EUCTR)
13/09/202109/07/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan;Korea, Republic of
30NCT05007340
(ClinicalTrials.gov)
August 24, 202129/7/2021ILD-SARDs Registry and BiorepositoryInterstitial Lung Disease in Systemic Autoimmune Rheumatic Diseases (ILD-SARDs) Registry and BiorepositoryInterstitial Lung Disease;Systemic Autoimmune Disease;Rheumatic Diseases;Rheumatic Arthritis;Systemic Sclerosis;Autoimmune Myositis;Systemic Lupus Erythematosus;Usual Interstitial Pneumonia;Nonspecific Interstitial PneumoniaOther: Blood draws;Other: Other biological samples to biobank (skin, lung and muscle biopsies; bronchoalveolar lavage (BAL fluid);Other: Clinical data collection;Other: Genetic data/DNA/RNAMcGill University Health Centre/Research Institute of the McGill University Health CentreMcGill UniversityRecruiting18 YearsN/AAll252Canada
31EUCTR2020-005764-62-PT
(EUCTR)
24/08/202119/08/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of
32EUCTR2020-005764-62-AT
(EUCTR)
16/08/202115/06/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
33NCT05000216
(ClinicalTrials.gov)
August 13, 20216/8/2021COVID-19 Booster Vaccine in Autoimmune Disease Non-RespondersBooster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)Rheumatoid Arthritis;Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis;Systemic Sclerosis (SSc)Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: IS (MMF or MPA);Drug: IS (MTX);Biological: IS (B cell depletion therapy)National Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc.Recruiting18 YearsN/AAll600Phase 2United States
34EUCTR2020-005764-62-ES
(EUCTR)
11/08/202111/08/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2;Phase 3Portugal;United States;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;Japan;Korea, Republic of
35EUCTR2020-005764-62-DE
(EUCTR)
09/08/202114/06/2021A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: HZN-825
INN or Proposed INN: HZN-825
Horizon Therapeutics Ireland DACNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Korea, Republic of
36NCT04966416
(ClinicalTrials.gov)
August 1, 202114/7/2021Calcinosis Reduction by Pyrophosphate in SSCThe Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic SclerosisSystemic Sclerosis;SclerodermaDietary Supplement: Pyrophosphate;Dietary Supplement: PlaceboSzeged UniversityResearch Centre for Natural Sciences;University of Debrecen Dept. of RheumatologyNot yet recruiting18 Years70 YearsAll60N/ANULL
37EUCTR2020-005116-21-ES
(EUCTR)
22/07/202122/07/2021FT011 for SclerodermaA phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma diffuse systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: FT011 100 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Product Name: FT011 200 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Certa Therapeutics Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Poland;Spain;Ukraine;Australia;Russian Federation;Netherlands
38NCT04647890
(ClinicalTrials.gov)
July 19, 202116/11/2020Effects of FT011 in Systemic SclerosisA Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic SclerosisScleroderma, Systemic;Scleroderma, Diffuse;Sclerosis, SystemicDrug: FT011;Drug: PlaceboCerta TherapeuticsNULLRecruiting18 Years75 YearsAll30Phase 2Australia
39NCT04627857
(ClinicalTrials.gov)
July 1, 20216/11/2020Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisEffect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic SclerosisScleroderma SystemicDevice: Manual toothbrush;Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss);Device: Sonic toothbrush;Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)University Hospital, Strasbourg, FranceNULLRecruiting18 YearsN/AAll100N/AFrance
40NCT04837131
(ClinicalTrials.gov)
April 28, 20215/4/2021A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease PatientsA Phase 2 Open-Label Pilot Study of the Safety and Tolerability of Ixazomib Administered Orally to Patients With Scleroderma-Related Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Diffuse Systemic Sclerosis;Diffuse Scleroderma;Diffuse Cutaneous Systemic Sclerosis;Diffuse Cutaneous Scleroderma;Progressive Systemic Sclerosis;Progressive Scleroderma;Scleroderma, Systemic;Scleroderma, Diffuse;Progressive;Systemic Sclerosis, Diffuse;Systemic; Sclerosis, Progressive;Scleroderma of Lung;Scleroderma With Pulmonary Involvement;Systemic Sclerosis Pulmonary;Systemic Sclerosis With Lung Involvement;Interstitial Lung Disease;Pulmonary Fibrosis InterstitialDrug: IxazomibW. Leroy GriffingNULLRecruiting18 YearsN/AAll12Phase 2United States
41NCT04781543
(ClinicalTrials.gov)
April 1, 20211/3/2021A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic SclerosisA Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic Sclerosis;Sclerosis, SystemicDrug: HZN-825 BID;Drug: Placebo;Drug: HZN-825 QDHorizon Therapeutics Ireland DACNULLRecruiting18 Years75 YearsAll300Phase 2United States;Argentina;France;Greece;Korea, Republic of;Portugal
42NCT04826419
(ClinicalTrials.gov)
April 1, 202129/3/2021Effect of Ozone Therapy for the Treatment of Digital Ulcer in Patients With SScNon-invazive Ozone Therapy and Digital Ulcer in Patients With SScSystemic SclerosisOther: ozone therapyPamukkale UniversityNULLCompleted18 Years75 YearsAll25N/ATurkey
43JPRN-jRCT2051200133
31/03/202112/02/2021A study of Guselkumab in Participants with Systemic SclerosisA Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants with Systemic Sclerosis Scleroderma, SystemicGroup A: Guselkumab Dose 1
Guselkumab Dose 1 will be administered intravenously.

Group A: Guselkumab Dose 2
Guselkumab Dose 2 will be administered subcutaneously.

Group B: Placebo
Placebo will be administered intravenously or subcutaneously.
Numaguchi HirotakaNULLRecruiting>= 18age old<= 75age oldBoth56Phase 2Japan
44EUCTR2021-000880-63-SE
(EUCTR)
11/03/202123/02/2021COVID-19 vaccine in patients with rheumatic diseases: The impact of treatments on the vaccine response protection against infection (COVID19-REUMA)COVID-19 vaccine in patients with inflammatory rheumatic diseases: The impact of immunomodulating treatments on the antibody response, T cells response and protection against infection (COVID19-REUMA) - COVID19-REUMA rheumatoid arthritis, SLE, systemic vasculitis, systemic sclerosis, spondylarthritis;Therapeutic area: Body processes [G] - Immune system processes [G12]Trade Name: Comirnaty
Product Name: Comirnaty
INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Trade Name: COVID-19 Vaccine AstraZeneca
Product Name: COVID-19 Vaccine AstraZeneca
INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])
Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
Trade Name: COVID-19 Vaccine Moderna
Product Name: COVID-19 Vaccine Moderna
INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Skåne University Hospital, department of rheumatology in Lud and MalmöNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
868Phase 4Sweden
45NCT04746313
(ClinicalTrials.gov)
March 1, 20218/2/2021Prevalence of Hyperprolactinemia in Systemic SclerodermaAssessment of the Prevalence of Hyperprolactinemia in Systemic SclerodermaSclerosis, Systemic;Scleroderma;HyperprolactinemiaBiological: blood testUniversity Hospital, LilleAssociation pour la Formation et la Recherche en Médecine Interne (AFORMI)Recruiting18 YearsN/AAll200France
46ChiCTR2100041982
2021-03-012021-01-10An Open-Label Clinical Study to Evaluate the 24-Week Efficacy and 52-Week Safety of Baricitinib in Patients with Early Diffuse Cutaneous Systemic SclerosisAn Open-Label Clinical Study to Evaluate the 24-Week Efficacy and 52-Week Safety of Baricitinib in Patients with Early Diffuse Cutaneous Systemic Sclerosis Systemic SclerosisA:baricitinib 4mg;B:baricitinib2mg;C:no intervention;Huashan Hospital, Fudan UniversityNULLRecruiting1870BothA:25;B:50;C:50;China
47ChiCTR2100042327
2021-03-012021-01-19Observation of curative effection of Milli Fire Needle in treating Localized SclerodermaFeasibility and Safety of Milli Fire Needle in Localized Scleroderma Treatment Localized Sclerodermatreatment group:Milli Fire Needle+0.1% tacrolimus oinment;control group:0.1% tacrolimus oinment;The First Affiliated Hospital of Guangzhou University of Chinese MedicineNULLRecruiting1865Bothtreatment group:45;control group:45;China
48NCT04683029
(ClinicalTrials.gov)
February 24, 202122/12/2020A Study of Guselkumab in Participants With Systemic SclerosisA Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic SclerosisScleroderma, SystemicDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: PlaceboJanssen Pharmaceutical K.K.NULLRecruiting18 Years75 YearsAll56Phase 2Japan
49NCT04440592
(ClinicalTrials.gov)
February 5, 202117/6/2020Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: MT-7117;Drug: PlaceboMitsubishi Tanabe Pharma Development America, Inc.NULLRecruiting18 YearsN/AAll72Phase 2United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
50EUCTR2020-000134-17-DE
(EUCTR)
27/01/202106/10/2020A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Dersimelagon
Product Code: MT-7117
INN or Proposed INN: Dersimelagon
Other descriptive name: MT-7117
Mitsubishi Tanabe Pharma Development America (MTDA), Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Poland;Spain;Belgium;Germany;United Kingdom;Italy
51NCT04515706
(ClinicalTrials.gov)
January 1, 202113/8/2020Iguratimod in Systemic SclerosisSafety, Tolerability, Efficacy of Iguratimod in Systemic SclerosisSystemic Sclerosis, DiffuseDrug: Iguratimod;Drug: PlaceboRenJi HospitalNULLNot yet recruiting19 Years74 YearsAll20N/ANULL
52NCT04744207
(ClinicalTrials.gov)
December 29, 202028/1/2021A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic SclerosisA Phase II, Randomized, Multi-center, Placebo-controlled, Double-blind Study to Investigate the Safety of GS-248, and Efficacy on Raynaud's Phenomenon (RP) and Peripheral Vascular Blood Flow, in Subjects With Systemic Sclerosis (SSc)Systemic SclerosisDrug: GS-248;Drug: PlaceboGesynta Pharma ABErgomedRecruiting18 Years75 YearsAll80Phase 2Belgium;Netherlands;Poland;United Kingdom
53NCT04680975
(ClinicalTrials.gov)
December 24, 202011/12/2020Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic SclerosisA Phase 2, Open-label Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis (dcSSc)Diffuse Cutaneous Systemic SclerosisDrug: BelumosudilKadmon Corporation, LLCNULLActive, not recruiting18 YearsN/AAll15Phase 2United States
54EUCTR2020-000134-17-GB
(EUCTR)
23/12/202005/08/2020A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled-Parallel-Group study to determine how safe, effective and tolerable MT-7117 is in subjects with Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Dersimelagon
Product Code: MT-7117
INN or Proposed INN: Dersimelagon
Other descriptive name: MT-7117
Mitsubishi Tanabe Pharma Development America (MTDA), Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Spain;Belgium;Germany;Italy;United Kingdom
55EUCTR2020-000134-17-IT
(EUCTR)
18/12/202015/06/2021A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-ControlledParallel-Group study to determine how safe, effective and tolerable MT7117 is in subjects with Diffuse Cutaneous Systemic SclerosisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, and Tolerability of MT7117 in Subjects with Diffuse Cutaneous Systemic Sclerosis - NA Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Dersimelagon
Product Code: [MT-7117]
Other descriptive name: A novel synthetic, orally-administered, non-peptide small molecule, which acts as an agonist of the melanocortin-1 receptor (MC1R)
Mitsubishi Tanabe Development America Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Spain;Belgium;Germany;United Kingdom;Italy
56EUCTR2020-002081-13-PL
(EUCTR)
09/12/202030/09/2020A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248
Gesynta Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Poland;Netherlands;United Kingdom
57NCT04303208
(ClinicalTrials.gov)
December 20203/3/2020Plasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic SclerosisPlasmacytoid Dendritic Cells and Toll Like Receptor 8 in Systemic SclerosisSystemic SclerosisProcedure: 2 ml of whole blood sample will be collected on EDTA tubeAssiut UniversityNULLNot yet recruiting18 YearsN/AAll80N/ANULL
58EUCTR2020-002081-13-NL
(EUCTR)
02/11/202017/08/2020A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in subjects with systemic sclerosis (SSc) Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248
Gesynta Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Poland;Netherlands;United Kingdom
59EUCTR2019-004718-32-NL
(EUCTR)
09/10/202009/10/2020Stem cell transplantation in diffuse cutaneous systemic sclerosis: upfront therapy or rescue therapy after failure of immunosuppressants?Upfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial Diffuse cutaneous systemic sclerosis according to the ACR/EULAR criteria;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Mycophenolate mofetilUMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Netherlands
60NCT04300426
(ClinicalTrials.gov)
September 24, 202025/2/2020Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue)Aiming to Reduce Disease-related Gastrointestinal Symptoms in Systemic Sclerosis by Repeat Intestinal Infusions of Anaerobic Cultivated Human Intestinal Microbiome (ACHIM); a Randomized, Double-blind Placebo-controlled 20 Week StudySystemic SclerosisDrug: ACHIM as solute (10^9 intestinal microbes/ml)Oslo University HospitalSouth-Eastern Norway Regional Health Authority;Haukeland University Hospital;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years85 YearsAll70Phase 2Norway
61NCT04356755
(ClinicalTrials.gov)
September 22, 202011/3/2020Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With SclerodermaSystemic SclerosisProcedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: PlaceboUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll32Phase 2France
62EUCTR2020-002081-13-GB
(EUCTR)
08/09/202021/07/2020A study to determine if the study drug (GS-248) is safe, and its effectiveness on Raynaud’s phenomenon (RP) and improving blood supply to fingers and toes in patients with systemic sclerosis (SSc).A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc) Raynaud's phenomenon (RP) in patients with Systemic sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10037917;Term: Raynauds;System Organ Class: 100000004866
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GS-248
Product Code: GS-248
INN or Proposed INN: GS-248
Gesynta Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United Kingdom
63EUCTR2019-003430-16-FR
(EUCTR)
28/07/202002/06/2020Safety and efficacy of itacitinib in adults with systemic sclerosisSafety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial - SCLERITA - SCLERITA Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Itacitinib
Product Code: INCB039110
INN or Proposed INN: ITACITINIB
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
74Phase 2France
64EUCTR2019-000906-31-DE
(EUCTR)
01/07/202031/10/2019Efficacy 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 Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
65NCT04166552
(ClinicalTrials.gov)
June 11, 20206/11/2019Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic SclerosisA Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients With Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Patients will be randomized to receive EHP-101 or PlaceboEmerald Health PharmaceuticalsNULLRecruiting18 Years74 YearsAll36Phase 2United States;Australia;New Zealand
66NCT04265144
(ClinicalTrials.gov)
June 8, 20205/2/2020Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference CentreCohort of Patients With Systemic Sclerosis and Associated Biological Collection Within the Framework of the RESO Reference Centre for Rare Systemic Autoimmune DiseasesScleroderma;Systemic SclerosisBiological: Blood samples;Other: Biopsy;Other: Bronchoalveolar samplesUniversity Hospital, BordeauxNULLRecruiting18 YearsN/AAll500N/AFrance
67NCT04244916
(ClinicalTrials.gov)
May 25, 20206/1/2020MPA AUC Monitoring in Patients Receiving MMF for Diffuse Cutaneous or Pulmonary Involvement in Systemic SclerosisProspective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic SclerosisSystemic SclerosisBiological: AUC of MPA measureAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll50France
68EUCTR2019-000906-31-GB
(EUCTR)
22/05/202029/10/2019Efficacy 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 Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
69NCT04200755
(ClinicalTrials.gov)
May 19, 202010/12/2019Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized SclerodermaA Randomized, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Dupilumab in Localized SclerodermaLocalized SclerodermaDrug: Dupilumab 300Mg Solution for Injection;Other: PlaceboUniversity of CologneNULLRecruiting18 YearsN/AAll45Phase 2Germany
70NCT04523506
(ClinicalTrials.gov)
May 8, 202019/7/2020The Effects of Botulinum Toxin on Oral Aperture in Patients With SclerodermaThe Effects of Botulinum Toxin on Oral Aperture in Patients With SclerodermaSclerodermaBiological: Botulinum toxin(Botox)University of Texas Southwestern Medical CenterNULLCompleted18 Years65 YearsAll17Early Phase 1United States
71ChiCTR2000031572
2020-05-012020-04-04A randomized controlled clinical study on the efficacy and safety of erbium laser percutaneous methotrexate in the treatment of localized sclerodermaA randomized controlled clinical study on the efficacy and safety of erbium laser percutaneous methotrexate in the treatment of localized scleroderma morpheacontrol group:Erbium laser;experimental group:erbium laser assisted delivery of methotrexate;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNULLRecruiting1865Bothcontrol group:28;experimental group:28;China
72NCT04325217
(ClinicalTrials.gov)
April 15, 202026/3/2020Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in JapanPost-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in JapanLung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll600Japan
73JPRN-jRCTs031200019
01/04/202021/04/2020Gastric emptying in systemic sclerosisEvaluation of gastric emptying in patients with systemic sclerosis and clinical features of patients with delayed gastric emptying Systemic sclerosis
systemic sclerosis, delayed gastric emptying;D012595
Gastric emptying in patients with systemic sclerosis will be evaluated by 13C breath test. In particular, patients will take test meal with acetate labelled with 13C and their breaths will be evaluated.Kuribayashi ShikoUraoka ToshioRecruiting>= 20age oldNot applicableBoth60N/AJapan
74EUCTR2019-000906-31-BE
(EUCTR)
19/03/202009/12/2019Efficacy 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 Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
188Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
75ChiCTR2000030370
2020-03-012020-02-29The efficacy and safety of sirolimus for the treatment of Systemic Sclerosis: a single-arm, single-center pilot studyThe efficacy and safety of sirolimus for the treatment of Systemic Sclerosis: a single-arm, single-center pilot study Systemic Sclerosistreatment group:sirolimus;The First Affiliated Hospital of China Medical UniversityNULLRecruiting18Bothtreatment group:20;China
76EUCTR2019-000906-31-IT
(EUCTR)
25/02/202022/01/2021Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis - NA efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: PRIVIGEN - 100 MG/ML - SOLUZIONE PER INFUSIONE USO ENDOVENOSO FLACONCINO(VETRO) 1 FLACONCINO DA 100 ML
Product Name: Immunoglobulina normale umana per somministrazione endovenosa
Product Code: [IgPro10]
CSL BEHRING GMBHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
77EUCTR2019-003906-28-FR
(EUCTR)
24/02/202018/11/2019Adipose tissu derived-stem cells injections from patients with sclerodermia to treat thier refractory digital ulcers. Subcutaneous injections of autologous cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma : a phase II study - ADUSE Patients with systemic sclerosis presenting digital ulcer : - located beyond the proximal interphalangeal joint, on finger surface (included periungueal ulcers), - of ischemic origin according to the physician, - not over subcutaneous calcifications or bone relief, - active DU - refractory after 10±2 weeks of standard of care (that is either still active or new occurrence despite standard of care);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: autologous ASCCHU de ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
78EUCTR2019-002444-24-GB
(EUCTR)
18/02/202018/12/2019Clinical trial of a single dose of treprostinil injected as a depot under the skin to investigate the effect on the digital blood flow and safety in patients with Raynaud’s Phenomenon due to Systemic SclerosisAn Exploratory Trial Assessing Vascular Digital Perfusion, Pharmacokinetics, Safety and Tolerability Following a Single Dose of CAM2043 (Treprostinil Subcutaneous Depot) in Patients with Raynaud’s Phenomenon Secondary to Systemic Sclerosis Raynaud’s phenomenon secondary to systemic sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CAM2043
Product Code: CAM2043
INN or Proposed INN: Treprostinil Sodium
Other descriptive name: TREPROSTINIL SODIUM
Camurus ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United Kingdom
79EUCTR2019-000906-31-PL
(EUCTR)
31/01/202006/12/2019Efficacy 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 Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Australia;Germany
80JPRN-jRCTs031180366
22/01/202018/03/2019The Effectiveness of Glycyrrhizin in Systemic SclerosisExploratory Clinical Study on the Effectiveness of Glycyrrhizin in Early Vascular Lesions of Systemic Sclerosis Systemic sclerosisTreatment with Glycyrrhizin for systemic sclerosisSumida HayakazuNULLRecruiting>= 20age old< 80age oldBoth20N/AJapan
81NCT03582800
(ClinicalTrials.gov)
January 6, 202013/6/2018Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySubcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySystemic Sclerosis;Dermatomyositis;iPPSD2Drug: STSUniversity Hospital, LimogesNULLRecruiting6 MonthsN/AAll40Phase 2France
82NCT04388176
(ClinicalTrials.gov)
January 3, 202011/5/2020Cold Challenge With C21 in RPA Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)Raynaud Phenomenon;Systemic SclerosisDrug: C21;Drug: PlaceboVicore Pharma ABSGS Life Sciences, a division of SGS Belgium NVRecruiting19 Years75 YearsAll16Phase 2United Kingdom
83NCT04656704
(ClinicalTrials.gov)
January 1, 202030/11/2020Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin DiseaseInvestigating Hyaluronidase in Treating Oral Microstomia in Patients With Sclerosing Skin DiseaseMicrostomia;Scleroderma;CREST Syndrome;Scleromyxedema;MorpheaDrug: hyaluronidase injected intradermallyBrigham and Women's HospitalNULLWithdrawn18 YearsN/AAll0Early Phase 1NULL
84NCT04138485
(ClinicalTrials.gov)
December 20, 201914/10/2019Efficacy 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 BehringNULLWithdrawn18 YearsN/AAll0Phase 2United States;Argentina;Australia;Belgium;Canada;France;Germany;Italy;Mexico;Poland;Spain;Switzerland;United Kingdom
85NCT03740724
(ClinicalTrials.gov)
December 18, 20196/11/2018A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)Morphea;Scleroderma, Localized;SclerodermaGenetic: FCX-013;Drug: veledimexCastle Creek Biosciences, LLC.NULLRecruiting18 YearsN/AAll10Phase 1/Phase 2United States
86EUCTR2019-000906-31-ES
(EUCTR)
16/12/201920/12/2019Efficacy 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 Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
188Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
87EUCTR2019-003203-35-GB
(EUCTR)
13/12/201905/09/2019NAA Phase 2, single-center, randomised, double-blind, placebo-controlled, cross-over, cold challenge study investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc) Systemic sclerosis (SSc)Raynaud’s phenomenon (RP)
MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: NA
Product Code: C21
INN or Proposed INN: NA
Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt
Vicore Pharma ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2United Kingdom
88NCT04095351
(ClinicalTrials.gov)
December 9, 201913/9/2019Connective 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 IngelheimRecruiting18 Years80 YearsAll120Austria
89EUCTR2019-000906-31-FR
(EUCTR)
03/12/201908/11/2019Efficacy 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 Sclerosis efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous (IV) administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 2United States;Spain;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
90EUCTR2019-002036-90-DE
(EUCTR)
02/12/201902/10/2019Study to test effectiveness and safety of the drug Dupilumab in patients with localized sclerodermaA randomized, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of subcutaneous Dupilumab in localized scleroderma - DupiMorph Localized scleroderma
MedDRA version: 21.1;Level: LLT;Classification code 10009206;Term: Circumscribed scleroderma;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10027979;Term: Morphea;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Dupilumab
Product Code: Dupilumab
INN or Proposed INN: Dupilumab
Other descriptive name: SAR231893
University of CologneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Germany
91NCT04040322
(ClinicalTrials.gov)
October 14, 201930/7/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)Raynaud's Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLCompleted18 YearsN/AAll198Phase 3United States
92EUCTR2019-001279-34-DE
(EUCTR)
30/09/201918/07/2019A 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 sclerosis Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;United Kingdom;Italy
93NCT04137224
(ClinicalTrials.gov)
September 19, 201921/10/2019Safety 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 BehringNULLActive, not recruiting18 YearsN/AAll27Phase 2Australia;Germany;Italy;Poland;United Kingdom;France
94EUCTR2019-001279-34-IT
(EUCTR)
17/09/201915/01/2021A 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 sclerosis - - Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: [G451990]
Other descriptive name: GLPG1690
GALAPAGOS NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;United Kingdom;Italy
95EUCTR2019-001279-34-GB
(EUCTR)
20/08/201924/05/2019A 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 sclerosis Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: ziritaxestat
Other descriptive name: GLPG1690
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;Italy;United Kingdom
96EUCTR2019-001279-34-ES
(EUCTR)
13/08/201911/06/2019A 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 sclerosis Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Belgium;Spain;Germany;United Kingdom;Italy
97EUCTR2018-001978-22-FR
(EUCTR)
31/07/201917/09/2018Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study.Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. - ITS Pilot Patient presenting with: - ectopic ossification secondary to iPPSD2 or - ectopic calcification secondary to dermatomyositis or - ectopic calcification secondary to systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10006935;Term: Calcification and ossification, unspecified;System Organ Class: 100000004867 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Sodium Thiosulfate 10%
Product Name: Sodium thiosulfate
INN or Proposed INN: Sodium thiosulfate 10%
Other descriptive name: SODIUM THIOSULFATE PENTAHYDRATE
CHU de LIMOGESNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
98NCT03844061
(ClinicalTrials.gov)
July 29, 201931/1/2019Belimumab 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
99NCT04045743
(ClinicalTrials.gov)
July 19, 201927/7/2019The Benefit of Bermekimab in Patients With Systemic SclerosisClinical Efficacy of Inhibition of Organ Dysfunction Through Bermekimab in Systemic Sclerosis: A Proof- Of-Concept Double-Blind Randomized Clinical Trial (the Light Trial)Scleroderma, SystemicDrug: MABp1 (Bermekimab) OR Placebo;Drug: MABp1 (Bermekimab)Hellenic Institute for the Study of SepsisNULLActive, not recruiting18 YearsN/AAll20Phase 2Greece
100NCT03976648
(ClinicalTrials.gov)
July 18, 20194/6/2019A 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 SclerosisSystemic SclerosisDrug: GLPG1690Galapagos NVNULLTerminated18 YearsN/AAll31Phase 2United States;Belgium;Italy;Spain;United Kingdom
101EUCTR2015-004613-24-BE
(EUCTR)
17/07/201918/04/2019Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early (very early) systemic sclerosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Solu-Medrol
Product Name: methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE SODIUM SUCCINATE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Belgium;Netherlands
102EUCTR2018-003149-41-DE
(EUCTR)
16/07/201920/03/2019Safety 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). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
103NCT03919799
(ClinicalTrials.gov)
July 9, 201921/11/2018KD025 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 Belumosudil (KD025) in Subjects With Diffuse Cutaneous Systemic SclerosisSystem; Sclerosis;Diffuse Cutaneous Systemic SclerosisDrug: Belumosudil (KD025);Drug: PlaceboKadmon Corporation, LLCNULLActive, not recruiting18 Years100 YearsAll60Phase 2United States
104NCT04036227
(ClinicalTrials.gov)
July 3, 201923/7/2019Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248A Phase I, Placebo-controlled, Double-blind, First-in-human Study to Investigate Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-248 Solution in Healthy Subjects and Patients With Systemic Sclerosis (SSc)HealthyDrug: GS-248;Drug: PlaceboGesynta Pharma ABCTC Clinical Trial ConsultantsCompleted18 Years75 YearsAll72Phase 1Sweden
105EUCTR2018-004655-20-GR
(EUCTR)
30/05/201931/01/2019THE BENEFIT OF BERMEKIMAB IN PATIENTS WITH SYSTEMIC SCLEROSISCLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL) - LIGHT CLINICAL EFFICACY OF INHIBITION OF ORGAN DYSFUNCTION THROUGH BERMEKIMAB IN SYSTEMIC SCLEROSIS: A PROOF-OF-CONCEPT DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL (THE LIGHT TRIAL)
MedDRA version: 20.0;Level: PT;Classification code 10078638;Term: Systemic scleroderma;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: BERMEKIMAB
INN or Proposed INN: N/A
Other descriptive name: BERMEKIMAB
HELLENIC INSTITUTE FOR THE STUDY OF SEPSISNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Greece
106EUCTR2018-003149-41-FR
(EUCTR)
24/05/201927/03/2019Safety 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). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
26 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Poland;Australia;Germany;Italy;United Kingdom
107JPRN-JapicCTI-194761
23/5/201917/05/2019A Phase 3 study of KHK4827 in patients with systemic sclerosisA Phase 3, placebo-controlled, double-blind comparative study of KHK4827 with an open-label extension period in subjects with systemic sclerosis who have moderate to severe skin thickening Systemic sclerosisIntervention name : KHK4827
INN of the intervention : Brodalumab
Dosage And administration of the intervention : 210 mg Q2W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : 210 mg Q2W, SC
Kyowa Kirin Co., Ltd.NULLcomplete1870BOTH100Phase 3Japan
108EUCTR2018-003149-41-IT
(EUCTR)
23/05/201922/01/2021Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc). - NA Safety and Pharmacokinetics in subjects with diffuse cutaneous systemicsclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Immunoglobulina Normale Umana per somministrazione sottocutanea
Product Code: [IgPro20]
INN or Proposed INN: IMMUNOGLOBULINA UMANA NORMALE
Trade Name: Privigen
Product Name: immunoglobulina Normale Umana per somministrazione endovenosa
Product Code: [IgPro10]
INN or Proposed INN: immunoglobulina normale umana
CSL BEHRING GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
109NCT03957681
(ClinicalTrials.gov)
May 23, 201916/5/2019A 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.NULLActive, not recruiting18 Years70 YearsAll100Phase 3Japan
110EUCTR2018-003149-41-GB
(EUCTR)
15/05/201930/07/2019Safety 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). - n/a Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Hizentra
Product Name: Human normal immunoglobulin for subcutaneous administration
Product Code: IgPro20
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Trade Name: Privigen
Product Name: Human normal immunoglobulin for intravenous administration
Product Code: IgPro10
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;Italy;United Kingdom
111NCT03198689
(ClinicalTrials.gov)
May 7, 201914/6/2017Brentuximab 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 InstituteSeagen Inc.Recruiting18 YearsN/AAll11Phase 2Canada
112EUCTR2018-001817-33-BE
(EUCTR)
05/04/201923/01/2019A 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 sclerosis Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;United Kingdom;Italy
113NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll312Phase 1United States;Canada
114EUCTR2018-001817-33-DE
(EUCTR)
29/03/201923/01/2019A 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 sclerosis Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;United Kingdom;Italy
115EUCTR2018-001817-33-IT
(EUCTR)
20/03/201925/01/2021A 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 sclerosis - - Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: [G451990]
Other descriptive name: GLPG1690
GALAPAGOS NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;United Kingdom;Italy
116NCT03867097
(ClinicalTrials.gov)
March 4, 20196/3/2019Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic SclerosisRaynaud Phenomenon Secondary to Systemic SclerosisDrug: Placebo IV infusion;Drug: Iloprost Injection, for intravenous useEicos Sciences, Inc.NULLCompleted18 YearsN/AAll41Phase 2United States
117EUCTR2018-001817-33-GB
(EUCTR)
14/01/201920/11/2018A 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 sclerosis Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GLPG1690
Product Code: G451990
INN or Proposed INN: Not applicable
Other descriptive name: GLPG1690
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Spain;Belgium;Germany;Italy;United Kingdom
118NCT03798366
(ClinicalTrials.gov)
January 14, 20193/1/2019A 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 SclerosisSystemic SclerosisDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll33Phase 2United States;Belgium;Germany;Italy;Spain;United Kingdom
119JPRN-jRCTc071190041
04/01/201909/01/2020A clinical trial of autologous stem cell transplantation for severe systemic sclerosisA single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis systemic sclerosisAfter peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted.Akashi KoichiNULLRecruiting>= 16age old< 65age oldBoth12Phase 2Japan
120NCT03831438
(ClinicalTrials.gov)
January 1, 201931/1/2019Safety 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 BiologicsNULLActive, not recruiting18 YearsN/AAll24Phase 1United States
121NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A 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 BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
122EUCTR2018-001719-65-NL
(EUCTR)
10/12/201809/07/2018 CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study Systemic sclerosis (SSc) is a rare progressive autoimmune disease hallmarked by severe vasculopathy. Patients are prone to enhanced calcification of skin and the vasculature. Active calcifications may not only occur in the skin of patients with clinically overt calcinosis cutis, but also in SSc patients without. Since calcification is strongly associated with local inflammation, it may very well occur in internal organs and serve as an early proxy for long-term SSc-related complications.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Product Name: Sodium fluoride 18F
Product Code: EMA/CHMP/212874/2015
University Medial Center GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
123NCT03742466
(ClinicalTrials.gov)
November 10, 201810/11/2018Local Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma PatientsLocal Injection of Ozone Versus Methylprednisolone Acetate in Carpal Tunnel Syndrome of Scleroderma Patients. A Single-blind Randomized Clinical TrialCarpal Tunnel Syndrome;Chronic Pain;SclerodermaDrug: Ozone;Drug: methylprednisolone acetateAssiut UniversityNULLCompleted20 Years60 YearsAll50N/AEgypt
124NCT03675581
(ClinicalTrials.gov)
November 8, 201817/9/2018A 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 IngelheimNULLCompleted18 YearsN/AFemale17Phase 1Belgium;France;Germany;Netherlands;Portugal;Spain
125NCT03211793
(ClinicalTrials.gov)
November 201827/4/2017Mesenchymal 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 DevelopmentUnknown status18 YearsN/AAll20Phase 1/Phase 2Netherlands
126EUCTR2016-003403-66-SE
(EUCTR)
15/10/201814/05/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
127NCT03717961
(ClinicalTrials.gov)
October 15, 201815/10/2018Efficacy 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 ParisNULLCompleted18 YearsN/AAll91Phase 3France
128EUCTR2017-000372-29-PL
(EUCTR)
28/09/201802/07/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Portugal;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
129EUCTR2016-003403-66-IT
(EUCTR)
28/09/201814/06/2021A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS(TM)- ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: [BIBF 1120]
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: [BIBF 1120]
INN or Proposed INN: NINTEDANIB
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
130EUCTR2017-000372-29-IT
(EUCTR)
25/09/201827/01/2021Clinical Trial to evaluate efficacy and eafety of Lenabasum in for the diffuse dutaneous systemic sclerosis, a disease of the immune system attacking the connective tissue under the skin and around internal organs and blood vessels causing scarring and thickening of the tissue in these areas.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5mg Powder in Capsule
Product Code: [JBT-101]
INN or Proposed INN: lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: [JBT-101]
Other descriptive name: resunab, ajulemic acid, anabasum
CORBUS PHARMACEUTICALS, INCNULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
131EUCTR2016-003403-66-GR
(EUCTR)
21/09/201814/05/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim B.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
132NCT03575156
(ClinicalTrials.gov)
September 20, 20187/6/2018Microparticles'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, BordeauxNULLActive, not recruiting18 YearsN/AAll208N/AFrance
133EUCTR2016-003417-95-NL
(EUCTR)
18/09/201809/07/2018Proof 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
INN or Proposed INN: GSK2330811
Other descriptive name: GSK2330811
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Canada;Netherlands;United Kingdom
134NCT03678987
(ClinicalTrials.gov)
September 13, 201813/9/2018Mycophenolate 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 SkaneNULLCompleted18 YearsN/AAll35Phase 1Sweden
135NCT03726398
(ClinicalTrials.gov)
September 1, 201821/10/2018CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PHCompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated Interstitial Lung DiseasE and Pulmonary Hypertension (PH): The CRuSADE PH StudyInterstitial Lung Disease;Scleroderma;Pulmonary HypertensionDrug: Opsumit 10 Mg TabletFranz Rischard, DONational Jewish Health;University of PittsburghRecruiting18 YearsN/AAll26Phase 2/Phase 3United States
136NCT03629002
(ClinicalTrials.gov)
September 20187/8/2018BIOLOGICAL 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 MarseilleNULLUnknown status18 YearsN/AAll30France
137NCT03558854
(ClinicalTrials.gov)
August 28, 20183/5/2018Evaluation 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 PauloNULLCompleted18 Years65 YearsAll70Phase 4Brazil
138NCT03630211
(ClinicalTrials.gov)
July 31, 20187/8/2018Autologous 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 SzabolcsNULLRecruiting16 Years70 YearsAll8Phase 2United States
139EUCTR2016-003403-66-FI
(EUCTR)
17/07/201829/06/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R) -ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Fnland KyNULLNot RecruitingFemale: yes
Male: yes
400Phase 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
140EUCTR2017-000372-29-NL
(EUCTR)
21/06/201824/01/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of
141EUCTR2016-003403-66-CZ
(EUCTR)
20/06/201812/04/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden
142NCT03856853
(ClinicalTrials.gov)
June 15, 201826/2/2019Efficacy 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
143NCT03644225
(ClinicalTrials.gov)
June 11, 20184/5/2018Suction Based Characterization of Healthy and Diseased SkinMechanical Characterization of Healthy and Diseased Skin With Suction Based Assessment of Skin DeformabilitySystemic SclerosisDevice: Measurment with Aspirational Medical Device;Device: Measurment with Cutometer MPA 580Oliver DistlerSwiss Federal Institute of TechnologyCompleted18 YearsN/AAll67N/ASwitzerland
144NCT03365869
(ClinicalTrials.gov)
June 1, 20184/12/2017A 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 HospitalNULLNot yet recruiting18 Years80 YearsAll72Phase 2NULL
145NCT03593902
(ClinicalTrials.gov)
May 17, 201828/6/2018Cardiac 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 UniversityNULLTerminated18 Years65 YearsAll9Phase 2/Phase 3United States
146NCT03508375
(ClinicalTrials.gov)
May 15, 201816/4/2018Evaluation 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 MarseilleNULLRecruiting18 YearsN/AAll75N/AFrance
147NCT03607071
(ClinicalTrials.gov)
May 15, 201820/7/2018Outcome 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 UniversityNULLCompleted18 YearsN/AAll20Phase 2Thailand
148EUCTR2017-000372-29-ES
(EUCTR)
25/04/201802/02/2018A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum 5 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum 20 mg Powder in Capsule
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Italy;Switzerland;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of;Sweden
149EUCTR2016-003403-66-AT
(EUCTR)
17/04/201828/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
150EUCTR2016-003403-66-BE
(EUCTR)
12/04/201812/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM) Extension Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 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
151EUCTR2016-003403-66-DK
(EUCTR)
05/04/201802/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-on Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
152EUCTR2016-003403-66-FR
(EUCTR)
04/04/201801/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 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
153JPRN-UMIN000031901
2018/04/0126/03/2018Efficacy of acotiamide for scleroderma patients with esophageal symptomsEfficacy of acotiamide for scleroderma patients with esophageal symptoms - Efficacy of acotiamide for scleroderma patients with esophageal symptoms. systemic sclerosisproton pump inhibitor
proton pump inhibitor and acotiamide
Juntendo University School of MedicineJuntendo Tokyo Koto Geriatric Medical CenterComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan
154EUCTR2017-000372-29-GB
(EUCTR)
20/03/201807/12/2017A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
354 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
155EUCTR2017-000372-29-DE
(EUCTR)
07/03/201813/12/2017A study of safety and efficacy of lenabasum in Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis - A Phase 3 safety and efficacy study of Lenabasum in Systemic Sclerosis Systemic Sclerosis (SSc)
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
156EUCTR2016-003403-66-PT
(EUCTR)
23/02/201813/12/2017A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Unilfarma - União Internacional de Lab. Farmacêuticos, Lda.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Norway;Japan;Sweden;United States;Portugal;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany
157EUCTR2016-003403-66-GB
(EUCTR)
07/02/201809/01/2018A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden
158NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow 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 HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
159EUCTR2016-003403-66-ES
(EUCTR)
19/01/201822/11/2017A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 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
160NCT03444220
(ClinicalTrials.gov)
January 18, 201813/2/2018Gut 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 HospitalNULLCompleted18 YearsN/AFemale10Phase 1/Phase 2Norway
161NCT03708718
(ClinicalTrials.gov)
December 21, 20178/10/2018Prednisolone in Early Diffuse Systemic SclerosisA Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)Systemic SclerosisDrug: Prednisolone 5 mg;Drug: Placebo oral capsule; From August 2020 'no additional treatment'Prof. Ariane herrickVersus ArthritisCompleted18 YearsN/AAll35Phase 2United Kingdom
162NCT03398837
(ClinicalTrials.gov)
December 18, 20175/1/2018Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsuleCorbus Pharmaceuticals Inc.NULLTerminated18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
163NCT04274257
(ClinicalTrials.gov)
December 4, 201713/2/2020A Study of the Efficacy and Safety of Rituximab in Participants With Systemic SclerosisDouble-Blind, Parallel-group Comparison, Investigators Initiated Phase II Clinical Trial of IDEC-C2B8 (Rituximab) in Patients With Systemic SclerosisScleroderma, Systemic;Skin Sclerosis;Lung Fibrosis;Autoimmune Diseases;Collagen DiseasesDrug: Double-Blind Placebo;Drug: Double-Blind RituximabTokyo UniversityJapan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd.Completed20 Years80 YearsAll56Phase 2/Phase 3Japan
164NCT03221257
(ClinicalTrials.gov)
November 28, 201712/7/2017Scleroderma Lung Study III - Combining Pirfenidone With MycophenolateScleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung DiseaseScleroderma, Systemic;Interstitial Lung DiseaseDrug: Pirfenidone (PFD);Drug: Placebo (Plac);Drug: Mycophenolate Mofetil (MMF)Michael RothUniversity of Michigan;Genentech, Inc.;University of California, Los AngelesActive, not recruiting18 YearsN/AAll51Phase 2United States
165NCT03313180
(ClinicalTrials.gov)
November 27, 201713/10/2017A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung FibrosisAn 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 IngelheimNULLActive, not recruiting18 YearsN/AAll444Phase 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
166JPRN-JapicCTI-173760
10/11/201707/11/2017Tocilizumab LTE study in patients with SScA PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic sclerosisIntervention name : tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/week, SC
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
CHUGAI PHARMACEUTICAL CO., LTDNULLcomplete18BOTH18Phase 3Japan
167EUCTR2016-003403-66-NL
(EUCTR)
06/11/201727/09/2017A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim bvNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
168JPRN-JapicCTI-173686
06/10/201729/08/2017A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosisA Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis systemic sclerosisIntervention name : KHK4827
INN of the intervention : brodalumab
Dosage And administration of the intervention : SC, 210 mg Q2W
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcomplete1870BOTH6Phase 1Japan
169NCT04368403
(ClinicalTrials.gov)
October 6, 201713/4/2020A Study of KHK4827 in Patients With Systemic SclerosisA Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic SclerosisSystemic SclerosisDrug: KHK4827Kyowa Kirin Co., Ltd.NULLActive, not recruiting18 Years70 YearsAll8Phase 1Japan
170NCT03274076
(ClinicalTrials.gov)
September 25, 201728/8/2017Evaluation 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 MichiganPfizerCompleted18 Years70 YearsAll15Phase 1/Phase 2United States
171NCT03222492
(ClinicalTrials.gov)
September 20, 201717/7/2017Brentuximab 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);Seagen Inc.;PPD;Rho Federal Systems Division, Inc.Recruiting18 Years70 YearsAll24Phase 1/Phase 2United States;Canada
172EUCTR2015-001617-27-BG
(EUCTR)
02/08/201717/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
173EUCTR2016-002651-25-GB
(EUCTR)
11/07/201708/05/2018A Study of Prednisolone in Patients with Early (within 3 years of onset) Diffuse Cutaneous Scleroderma (Systemic Sclerosis)A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis - PRedSS: Prednisolone in Early Diffuse Systemic Sclerosis. Version 1.0 Early diffuse cutaneous systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Prednisolone 5mg Gastro-resistant Tablets
Product Name: Prednisolone 5mg Gastro-resistant Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: Prednisolon;Prednisolona; Prednisoloni; Prednisolonum; Prednizolon;Prednizolonas
Research Governance and Integrity, University of ManchesterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United Kingdom
174EUCTR2015-000392-28-CZ
(EUCTR)
27/06/201727/04/2017A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 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
175NCT03120533
(ClinicalTrials.gov)
June 20, 201723/3/2017Treprostinil 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 AlpsCompleted18 YearsN/AAll18Phase 1/Phase 2France
176EUCTR2015-000392-28-HU
(EUCTR)
08/06/201726/04/2017A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
177NCT03041025
(ClinicalTrials.gov)
June 5, 201731/1/2017Proof 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: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll35Phase 2United States;Canada;Netherlands;United Kingdom
178EUCTR2015-000392-28-NO
(EUCTR)
02/06/201715/02/2017A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Norway KSNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden
179NCT03155464
(ClinicalTrials.gov)
June 1, 201724/4/2017Intraoperative 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 UniversityNULLWithdrawn18 YearsN/AAll0Phase 4NULL
180NCT04822038
(ClinicalTrials.gov)
June 1, 201712/2/2021Immunomodulating Effects of Supplementation With 25-OH Vitamin DImmunomodulating Effects of Supplementation With 25 oh Vitamin D in Adults With Scleroderma and Hypovitaminosis DVitamin D Deficiency;Scleroderma, SystemicDietary Supplement: Vitamin D3;Other: Dietary recommendationsCoordinación de Investigación en Salud, MexicoNULLCompleted18 YearsN/AAll49N/AMexico
181EUCTR2015-001617-27-SI
(EUCTR)
26/05/201715/05/2017A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
182EUCTR2015-000392-28-AT
(EUCTR)
12/05/201731/03/2017A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia
183EUCTR2015-000392-28-SE
(EUCTR)
08/05/201724/02/2017A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel
184NCT03068234
(ClinicalTrials.gov)
May 201716/2/2017Pirfenidone 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 HospitalNULLNot yet recruiting18 Years70 YearsAll72Phase 2/Phase 3China
185JPRN-UMIN000026859
2017/04/1005/04/2017Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis systemic sclerosisacotinamaide hydrpchloride
100 mg tablets, 3 times/day, 28 days
trimebutine maleateon
100 mg tablets, 3 times/day, 28 days
Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of MedicineJapanese Cross Society Matsue JCS HospitalShimane Prefecture central HospitalPending20years-oldNot applicableMale and Female40Phase 3Japan
186EUCTR2015-000392-28-FI
(EUCTR)
21/02/201710/02/2017A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Finland KyNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
187EUCTR2016-002984-32-IT
(EUCTR)
16/02/201705/02/2018NDTreatment of the Reynaud's Disease associated with ischemic ulcers in patients affected by sistemic sclerosis - ND SISTEMIC SCLEROSIS
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
INN or Proposed INN: ILOPROST TROMETAMOL
Other descriptive name: ILOPROST SALE DI TROMETAMOLO
Trade Name: ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA
Product Name: ENDOPROST
Product Code: ND
INN or Proposed INN: ILOPROST TROMETAMOL
Other descriptive name: ILOPROST SALE DI TROMETAMOLO
UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
238Phase 4Italy
188EUCTR2015-002586-39-BE
(EUCTR)
19/01/201714/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Switzerland;Italy;United Kingdom;Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany
189EUCTR2016-003417-95-GB
(EUCTR)
13/01/201724/10/2016Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis.A multi-centre, randomized, double-blind (sponsor open), placebo controlled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis. - Proof of mechanism study of GSK2330811 in diffuse cutaneous systemic sclerosis. Systemic sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: GSK2330811 Solution for Injection, 100mg/ml
Product Code: GSK2330811
INN or Proposed INN: GSK2330811
Other descriptive name: GSK2330811
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Netherlands;United Kingdom
190NCT03059979
(ClinicalTrials.gov)
January 201725/1/2017The 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 UniversityNULLRecruiting18 YearsN/AAll30Early Phase 1Netherlands
191NCT02866552
(ClinicalTrials.gov)
January 20175/8/2016SCLERoderma et Adipose-DErived Stroma CellsSystemic SclerosisDrug: Stromal Vascular fraction;Drug: Ringer lactateAssistance Publique Hopitaux De MarseilleNULLNot yet recruiting18 YearsN/ABoth44Phase 2France
192NCT02682511
(ClinicalTrials.gov)
January 20178/2/2016Oral 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 PharmaceuticalsNULLRecruiting18 Years80 YearsAll34Phase 2United States;India
193NCT02921971
(ClinicalTrials.gov)
December 21, 201630/9/2016Effectiveness 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;Drug: PlaceboSanofiNULLCompleted18 YearsN/AAll97Phase 2United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
194EUCTR2016-001028-80-IT
(EUCTR)
19/12/201605/11/2020Effectiveness 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 study - NA Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NA
Product Code: SAR156597
INN or Proposed INN: non applicabile
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
195JPRN-UMIN000024818
2016/12/1214/11/2016The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosisThe efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis - The efficacy and safety of BTX-B on digital ulcers in patients with SSc digital ulcers in systemic sclerosis patientsplacebo subcutaneously injection into hands with digital ulcers
botulinum toxin type B subcutaneously injection into hands with digital ulcers
Gunma University HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female20Not selectedJapan
196NCT03007004
(ClinicalTrials.gov)
December 12, 201628/12/2016Effect 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: Botulinum toxin type B (2500 units / vial);Drug: Physiological salineGunma UniversityNULLCompleted18 YearsN/AAll10Phase 2Japan
197NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To 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 ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
198NCT02981082
(ClinicalTrials.gov)
December 201630/11/2016Dimethyl 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 LafyatisBiogenTerminated18 Years80 YearsAll6Phase 1United States
199EUCTR2016-001028-80-DE
(EUCTR)
08/11/201618/07/2016Effectiveness 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 study Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
200NCT03388255
(ClinicalTrials.gov)
November 8, 201621/12/2017Efficacy and Safety of PLACENTEX ® i.m. in Patients With Scleroderma DiseasesA Phase IV, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of PLACENTEX ® Polydeoxyribonucleotide i.m. in Patients With Fibrotic and Atrophic Cutaneous Lesions in Scleroderma DiseasesScleroderma DiseaseDrug: PolydeoxyribonucleotidesMastelli S.r.lSintesi Research SrlTerminated18 YearsN/AAll25Phase 4Italy
201NCT02975960
(ClinicalTrials.gov)
October 25, 20169/11/2016ADMSCs 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 HospitalCompleted18 YearsN/AAll7N/AKorea, Republic of
202EUCTR2015-002586-39-GB
(EUCTR)
18/10/201619/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;Switzerland;United Kingdom
203EUCTR2015-000424-28-IE
(EUCTR)
17/10/201619/08/2016A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
204EUCTR2016-001028-80-EE
(EUCTR)
04/10/201620/09/2016Effectiveness 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 study Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
205EUCTR2015-002586-39-PT
(EUCTR)
03/10/201606/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3France;United States;Portugal;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
206NCT02663895
(ClinicalTrials.gov)
October 201619/1/2016Safety 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 TherapeuticsCompleted18 YearsN/AAll12Phase 2United States
207NCT02896205
(ClinicalTrials.gov)
October 201627/8/2016Study 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 ResearchNULLCompleted18 YearsN/AAll41Phase 3India
208EUCTR2016-001028-80-AT
(EUCTR)
30/09/201627/07/2016Effectiveness 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 study Systemic sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
209NCT02798055
(ClinicalTrials.gov)
September 30, 20163/6/2016Bosentan 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.NULLCompleted18 Years80 YearsAll148Greece
210EUCTR2016-001028-80-BE
(EUCTR)
26/09/201602/08/2016Effectiveness 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 study Systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: SAR156597sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
211EUCTR2015-002586-39-HU
(EUCTR)
20/09/201612/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy in Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot Recruiting Female: yes
Male: yes
148 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
212EUCTR2015-002586-39-FR
(EUCTR)
13/09/201621/07/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;United States;France;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
213NCT02915835
(ClinicalTrials.gov)
September 201615/9/2016Riociguat in Scleroderma Associated Digital UlcersA Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital UlcersScleroderma;Digital UlcersDrug: Riociguat;Drug: PlaceboDinesh Khanna, MD, MSBayerCompleted18 YearsN/AAll17Phase 2United States
214EUCTR2015-005023-11-IT
(EUCTR)
29/08/201623/02/2018Abituzumab 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) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
Product Code: EMD 525797
INN or Proposed INN: abituzumab
MERCK KGAANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;United Kingdom;Italy
215EUCTR2015-002586-39-DE
(EUCTR)
03/08/201629/06/2016Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - TERGISS Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
medac GmbHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
216EUCTR2015-002586-39-IT
(EUCTR)
27/07/201606/02/2018Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic SclerosisRandomized, Multicenter, Double-Blind, Placebo-Controlled Trial toEvaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapyin Subjects With Diffuse Cutaneous Systemic Sclerosis - Terguride Plus Symptomatic Therapy in Patients with Diffuse Cutaneous Systemic Sclerosis Diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Product Name: Terguride
Product Code: /
INN or Proposed INN: TERGURIDE HYDROGENMALEATE
Trade Name: METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL
Product Name: Metoclopramide
Product Code: /
INN or Proposed INN: METOCLOPRAMIDE
Other descriptive name: METOCLOPRAMIDE
MEDAC GMBHNULLNot RecruitingFemale: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;United Kingdom;Switzerland;Italy
217EUCTR2015-005100-28-IT
(EUCTR)
18/07/201617/01/2022A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in patients with cutaneous lesions in scleroderma diseases.A phase IV, single-arm, open-label clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ Polydeoxyribonucleotide i.m. in patients with fibrotic and atrophic cutaneous lesions in scleroderma diseases. - A clinical trial to evaluate the efficacy and safety of PLACENTEX ¿ administered intra-muscular in p Fibrotic and atrophic cutaneous lesions in localized scleroderma diseases.
MedDRA version: 20.0;Level: HLT;Classification code 10039711;Term: Scleroderma and associated disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: PLACENTEX ¿5.625 mg/3 ml soluzione iniettabile¿
Product Name: PLACENTEX ¿ Polydeoxyribonucleotide 5.625 mg/3 ml
INN or Proposed INN: POLYDEOXYRIBONUCLEOTIDES
Other descriptive name: PLACENTEX ® Polydeoxyribonucleotide
MASTELLI SRLNULLNot RecruitingFemale: yes
Male: yes
45Phase 4Italy
218EUCTR2015-000168-32-NL
(EUCTR)
13/07/201609/07/2015Mesenchymal 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 Trial systemic sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Mesenchymal stem cells
Product Code: MSC
INN or Proposed INN: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
Other descriptive name: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
University Medical Center UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Netherlands
219EUCTR2015-005023-11-PL
(EUCTR)
12/07/201620/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Spain;Poland;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
220EUCTR2015-005023-11-GB
(EUCTR)
08/07/201625/05/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 20.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
221EUCTR2015-005023-11-ES
(EUCTR)
04/07/201627/06/2016Abituzumab in SSc-ILDA Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
MedDRA version: 19.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Abituzumab
INN or Proposed INN: abituzumab
Other descriptive name: DI-17E6; Anti-CT51 antigen mAb; Anti-integrin alphaV mAb
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
175Phase 2France;United States;Canada;Argentina;Poland;Spain;Singapore;Turkey;Australia;Israel;Italy;United Kingdom
222JPRN-UMIN000022624
2016/07/0106/06/2016Clinical 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 GVHD The patients with systemic sclerosis or sclerodermatous chronic GVHD.treatment with tocilizumab
duration: 116 weeks
dosage: 8mg/kg
times: 6 times
Frequency: every 4 weeks
Kanazawa University HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female5Not selectedJapan
223EUCTR2015-000392-28-IE
(EUCTR)
27/06/201613/04/2016A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot 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
224EUCTR2015-001617-27-NL
(EUCTR)
07/06/201606/04/2016A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Switzerland
225NCT02801305
(ClinicalTrials.gov)
June 20169/6/2016Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital UlcersAssessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.Digital Ulcer of SclerodermaDrug: Diltiazem Gel 2%;Drug: Nitroglycerin Ointment 2%;Drug: VaselineMohammad Ali NazariniaShiraz University of Medical SciencesCompleted20 Years70 YearsAll90Phase 2Iran, Islamic Republic of
226NCT02733978
(ClinicalTrials.gov)
June 201625/3/2016Ozone 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 UniversityNULLCompletedN/AN/AAll50N/ANULL
227NCT02745145
(ClinicalTrials.gov)
May 31, 201615/4/2016Abituzumab in SSc-ILDA Phase II, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy and Safety of Abituzumab in Subjects With Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)Systemic Sclerosis-associated Interstitial Lung DiseaseDrug: Abituzumab 1500 mg;Drug: Abituzumab 500 mg;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years75 YearsAll24Phase 2United States;Argentina;Australia;Canada;Israel;Italy;Poland;Spain;United Kingdom;Germany;Turkey
228EUCTR2015-004613-24-NL
(EUCTR)
30/05/201613/04/2016Hit 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
INN or Proposed INN: methylprednisolon
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
RadboudumcNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Netherlands
229EUCTR2014-002796-28-NL
(EUCTR)
12/04/201623/04/2015Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes?The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Tracleer
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
University Medical Center Groningen (UMCG)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
230EUCTR2015-000392-28-PL
(EUCTR)
09/03/201621/01/2016A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim RCV GmbH&Co KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
231NCT02370693
(ClinicalTrials.gov)
March 201611/2/2015Comparing 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
232NCT02680717
(ClinicalTrials.gov)
March 20169/2/2016Comparative Effectiveness Trial in the Treatment of Pediatric Plaque MorpheaComparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque MorpheaSclerodermaDrug: Clobetasol;Drug: Calcipotriene;Drug: TacrolimusMedical College of WisconsinMayo Clinic;Seattle Children's Hospital;University of TorontoWithdrawn2 Years18 YearsAll0Phase 1NULL
233NCT02588625
(ClinicalTrials.gov)
February 201626/10/2015A 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 SquibbNULLWithdrawn18 YearsN/ABoth0Phase 2United States;Canada;Poland;United Kingdom;France
234NCT02426229
(ClinicalTrials.gov)
February 20164/3/2015Safety & Suitability of Dabigatran to Inhibit Thrombin in SclerodermaSafety & Suitability of Dabigatran to Inhibit Thrombin in SclerodermaScleroderma;Interstitial Lung DiseaseDrug: dabigatran etexilateMedical University of South CarolinaNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed18 Years70 YearsAll15Phase 1United States
235EUCTR2015-000424-28-GR
(EUCTR)
26/01/201630/12/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
236EUCTR2015-000392-28-PT
(EUCTR)
08/01/201614/09/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
237JPRN-JapicCTI-152963
08/1/201609/07/2015Phase III Study of Tocilizumab in Patients with Systemic SclerosisA PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic SclerosisIntervention name : Tocilizumab
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg/W, SC
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo/W, SC
Chugai Pharmaceutical Co., Ltd.F.Hoffmann-La Roche Ltdcomplete18BOTH210Phase 3Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.
238NCT02530996
(ClinicalTrials.gov)
January 1, 201629/7/2015Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentSystemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and TreatmentRheumatologic DiseaseDrug: BH4;Diagnostic Test: Vasculopathy assessment;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years95 YearsAll12Phase 1/Phase 2United States
239NCT03141125
(ClinicalTrials.gov)
January 201620/6/2016The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard TherapyThe Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and FibrosisSclerodermaOther: Physalis angulata ethanol extract;Other: PlaceboIndonesia UniversityNetherlands: Ministry of Health, Welfare and SportsCompleted18 Years60 YearsAll62N/AIndonesia
240EUCTR2015-000392-28-IT
(EUCTR)
23/12/201508/06/2021A 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) - SENSCIS¿ Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden
241EUCTR2015-000424-28-NL
(EUCTR)
22/12/201521/09/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
242EUCTR2015-000424-28-HR
(EUCTR)
18/12/201501/02/2016A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
243EUCTR2015-000392-28-FR
(EUCTR)
11/12/201514/12/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
244EUCTR2015-000392-28-BE
(EUCTR)
08/12/201525/09/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
520Phase 3Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China
245NCT02453256
(ClinicalTrials.gov)
November 20, 201521/5/2015A 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 RocheNULLCompleted18 YearsN/AAll212Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa
246EUCTR2015-000392-28-ES
(EUCTR)
19/11/201505/10/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
247EUCTR2015-000392-28-GR
(EUCTR)
18/11/201522/10/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Ellas SANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
248NCT02597933
(ClinicalTrials.gov)
November 12, 20158/10/2015A 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)Scleroderma, SystemicDrug: Nintedanib;Drug: PlaceboBoehringer IngelheimNULLCompleted18 YearsN/AAll580Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom
249EUCTR2015-000392-28-DE
(EUCTR)
11/11/201525/08/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
250EUCTR2015-000392-28-GB
(EUCTR)
10/11/201501/09/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
251EUCTR2015-000392-28-NL
(EUCTR)
02/11/201524/08/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim bvNULLNot RecruitingFemale: 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
252NCT03531216
(ClinicalTrials.gov)
November 2, 20159/5/2018Topical 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 TuebingenCompleted18 YearsN/AAll12N/AGermany
253EUCTR2015-000424-28-DE
(EUCTR)
02/11/201527/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
254NCT02503644
(ClinicalTrials.gov)
October 29, 201530/6/2015Proof-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 PharmaNULLCompleted18 Years75 YearsAll145Phase 2Bulgaria;France;Germany;Italy;Netherlands;Poland;Slovenia;Spain;Switzerland;United Kingdom
255EUCTR2015-001617-27-DE
(EUCTR)
23/10/201528/08/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 20.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: LANIFIBRANOR
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
256EUCTR2015-000424-28-LT
(EUCTR)
14/10/201529/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
257JPRN-UMIN000020389
2015/10/0106/01/2016Clinical 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 GVHD The patients with systemic sclerosis or sclerodermatous chronic GVHD.treatment with tocilizumab
duration: 20 weeks
dosage: 8mg/kg
times: 6 times
Frequency: every 4 weeks
Kanazawa University Hospital, Department of dermatologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female5Not selectedJapan
258EUCTR2015-000392-28-DK
(EUCTR)
22/09/201522/09/2015A 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-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
259EUCTR2015-000424-28-HU
(EUCTR)
22/09/201511/08/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED Systemic Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
260EUCTR2015-001617-27-IT
(EUCTR)
18/09/201517/06/2015A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Switzerland;Italy
261EUCTR2015-001617-27-GB
(EUCTR)
16/09/201517/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc) - IVA337 SSc POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 19.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSlovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom
262EUCTR2014-005323-27-GB
(EUCTR)
16/09/201529/09/2015A 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;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: Abatacept
Other descriptive name: Orencia
University of MichiganNULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Italy;United Kingdom
263EUCTR2015-000424-28-DK
(EUCTR)
10/09/201517/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noJapan;Germany;Bulgaria;Romania;Croatia;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;United Kingdom;Lithuania;Netherlands;South Africa;Denmark;France;Italy;Switzerland;Ireland;Spain;Greece;Portugal;United States
264EUCTR2015-001617-27-ES
(EUCTR)
08/09/201510/07/2015A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337. Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. - IVA337 SSC POC Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs.
MedDRA version: 18.0;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10074034;Term: Generalised scleroderma;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IVA337
Product Code: IVA337
INN or Proposed INN: IVA337
Other descriptive name: 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
Inventiva SASNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland
265EUCTR2015-000424-28-IT
(EUCTR)
07/09/201530/09/2021A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO ASSESS THEEFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - NA Systemic Sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE
Product Name: tocilizumab
Product Code: [RO487-7533/F10-04]
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan
266EUCTR2015-000424-28-BE
(EUCTR)
07/09/201528/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
267NCT02551042
(ClinicalTrials.gov)
September 201517/12/2014CSL 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
268NCT02558543
(ClinicalTrials.gov)
September 201531/8/2015Subcutaneous 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 MarseilleNULLTerminated18 YearsN/AAll40Phase 2France
269NCT04387825
(ClinicalTrials.gov)
August 13, 201510/5/2020Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic SclerosisLipograft Safety Enriched With Vascular Stromal Fraction Derived From Adipose Tissue, to Treatment of Digital Joint Fibrosis and Refractory Ischemic Digital Ulcers Caused by Systemic SclerosisSystemic SclerosisDrug: ADSVF application in the right handInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNational Council of Science and Technology, MexicoCompleted18 YearsN/AAll20Phase 2Mexico
270EUCTR2015-000424-28-ES
(EUCTR)
07/08/201504/08/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
271NCT02465437
(ClinicalTrials.gov)
August 20154/6/2015Safety, 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.NULLActive, not recruiting18 Years70 YearsAll42Phase 2United States
272EUCTR2015-000424-28-PT
(EUCTR)
31/07/201530/07/2015A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS Systemic Sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
273JPRN-UMIN000018376
2015/07/2222/07/2015Efficacy 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 disease Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)1) Induction Therapy
rituximab 375mg/m2 (max500mg)
1-4 times/1-2 weeks

2) Maintenance Therapy
rituximab 375mg/m2 (max500mg)
1 times/6-12 months
Yokohama City University Hospital Department of PediatricsNULLComplete: follow-up complete2years-oldNot applicableMale and Female20Not selectedJapan
274NCT02480335
(ClinicalTrials.gov)
June 26, 201515/6/2015The 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 GroningenActelionCompleted18 YearsN/AAll20Phase 4Netherlands
275NCT02371005
(ClinicalTrials.gov)
June 201518/2/2015Oral Manifestations of Systemic SclerosisOral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic MarkersScleroderma, SystemicRadiation: Cone Beam Computed Tomography (CBCT)University Hospital, Strasbourg, FranceNULLTerminated18 YearsN/AAll85N/AFrance
276NCT03692299
(ClinicalTrials.gov)
June 201520/12/2016Effectiveness 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: Saccharomyces Boulardii Oral Tablet;Drug: MetronidazoleCoordinación de Investigación en Salud, MexicoNULLCompleted18 Years65 YearsAll39Phase 4Mexico
277NCT02349009
(ClinicalTrials.gov)
June 201518/1/2015Trial 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.NULLCompleted18 YearsN/AAll17Phase 1/Phase 2United States
278NCT02386436
(ClinicalTrials.gov)
April 21, 20156/3/2015A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy SubjectsA Phase I, Randomised, Double-blind (Sponsor Open), Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330811 in Healthy SubjectsScleroderma, SystemicDrug: GSK2330811;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years65 YearsAll41Phase 1United Kingdom
279EUCTR2014-001353-16-GB
(EUCTR)
17/04/201503/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 m
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
280NCT02356809
(ClinicalTrials.gov)
March 201526/1/2015Safety 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 yet recruiting18 Years65 YearsBoth30Phase 1/Phase 2Russian Federation
281NCT02411643
(ClinicalTrials.gov)
March 20153/3/2015Molecular Effects of Topical Calcipotriene on MorpheaMolecular Effects of Topical Calcipotriene on MorpheaMorphea;Localized SclerodermaDrug: topical calcipotriene 0.005% ointmentNorthwestern UniversityNULLTerminated18 YearsN/AAll2N/AUnited States
282EUCTR2014-001101-40-GB
(EUCTR)
24/02/201514/01/2015Investigation of safety and therapeutic effect of Fibrogammin® in SclerodermaSclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII Systemic Sclerosis
MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859
MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Fibrogammin® 1250
Product Name: Fibrogammin® 1250
INN or Proposed INN: blood coagulation factor XIII
University College London (UCL)NULLNot Recruiting Female: yes
Male: yes
26 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
283EUCTR2014-001353-16-DE
(EUCTR)
19/02/201516/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan
284NCT02370784
(ClinicalTrials.gov)
February 201526/1/2015Atorvastatin 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)Completed18 Years70 YearsAll24Phase 2United States
285EUCTR2014-001353-16-CZ
(EUCTR)
22/01/201506/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
286EUCTR2014-001353-16-IT
(EUCTR)
19/01/201514/05/2015Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE
INN or Proposed INN: Riociguat
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
287NCT02283762
(ClinicalTrials.gov)
January 15, 20153/11/2014Efficacy 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: PlaceboBayerNULLCompleted18 YearsN/AAll121Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain
288NCT02642146
(ClinicalTrials.gov)
January 201524/12/2015Treatment 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 HospitalNULLTerminated18 YearsN/AAll71Korea, Republic of
289NCT02165111
(ClinicalTrials.gov)
January 201511/6/2014Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's SyndromeA Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's SyndromeScleroderma;Raynaud's SyndromeDrug: Onabotulinumtoxin A;Drug: sterile saline solutionJohns Hopkins UniversityAllerganCompleted18 YearsN/AAll40Phase 3United States
290EUCTR2014-001353-16-NL
(EUCTR)
31/12/201420/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
291EUCTR2014-001353-16-HU
(EUCTR)
30/12/201414/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan
292EUCTR2014-001353-16-ES
(EUCTR)
22/12/201403/11/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 2.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
293EUCTR2014-001353-16-BE
(EUCTR)
09/12/201421/10/2014Effectiveness and safety of riociguat in patients with sclerosis of the skinA Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) diffuse cutaneous systemic sclerosis (dcSSc)
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Adempas
Product Name: riociguat coated tablet 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riociguat coated tablet 1.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: riocigu
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
294NCT02363478
(ClinicalTrials.gov)
December 201429/1/2015Long 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, AthensNULLCompleted18 Years75 YearsAll22Early Phase 1Greece
295JPRN-UMIN000017617
2014/11/0119/05/2015Effect of botulinum toxin A on Raynaud's phenomenon in patients with systemic sclerosis Raynaud's phenomenonBotulinum toxin A injectionGunma University HospitalNULLComplete: follow-up complete18years-oldNot applicableMale and Female10Not selectedJapan
296NCT02374320
(ClinicalTrials.gov)
November 201423/2/2015Exparel as a Nerve Block for Severe Hand PainChemical Sympathectomy Following Peripheral Nerve Block With Liposomal BupivacaineCREST Syndrome;Peripheral Vascular Disease;Raynaud Disease;Scleroderma, DiffuseDrug: liposomal bupivacaineJose Soberon, MDNULLTerminated18 YearsN/AAll14Phase 2/Phase 3United States
297NCT01862926
(ClinicalTrials.gov)
November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsCompleted18 Years80 YearsAll104Phase 2/Phase 3United Kingdom
298NCT02228850
(ClinicalTrials.gov)
November 201420/8/2014Study 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.)NULLCompleted18 Years79 YearsBoth35Phase 2United States
299EUCTR2014-000865-34-DE
(EUCTR)
31/10/201410/09/2014A 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 Sclerosis Raynaud's Phenomenon secondary to Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom
300EUCTR2014-001882-28-DE
(EUCTR)
13/10/201407/08/2014Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Volibris
Product Name: Ambrisentan
Thoraxklinik-Heidelberg gGmbHNULLNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
301NCT02047708
(ClinicalTrials.gov)
October 201422/1/2014Zibotentan Better Renal Scleroderma Outcome StudyA Phase II, Single Centre, Randomised, Placebo-controlled, 3-part Trial to Assess the Safety, Tolerability and Efficacy of Zibotentan in Patients With Renal Disease Secondary to SclerodermaScleroderma;Scleroderma Renal Crisis;Chronic Kidney DiseaseDrug: ZibotentanUniversity College, LondonMedical Research CouncilCompleted18 YearsN/AAll27Phase 2United Kingdom
302NCT02260557
(ClinicalTrials.gov)
October 20146/10/2014Effects 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: PlaceboActelionNULLCompleted18 YearsN/ABoth74Phase 2France;Germany;United Kingdom
303EUCTR2014-000865-34-GB
(EUCTR)
16/09/201410/09/2014A 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 Sclerosis Raynaud's Phenomenon secondary to Systemic Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom
304NCT02161406
(ClinicalTrials.gov)
September 20143/6/2014A 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)Completed18 YearsN/AAll88Phase 2United States;Canada;United Kingdom
305NCT02290613
(ClinicalTrials.gov)
July 1, 201431/10/2014Early 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 UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
306NCT02166229
(ClinicalTrials.gov)
June 201410/6/2014Divalproex Sodium in the Treatment of the Cutaneous Manifestations of SclerodermaScleroderma;Systemic SclerosisDrug: Divalproex sodiumYale UniversityNULLWithdrawn18 YearsN/ABoth0Phase 1/Phase 2United States
307NCT02213705
(ClinicalTrials.gov)
May 6, 201417/7/2014Treatment 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 ParisNULLActive, not recruiting18 Years70 YearsAll20Phase 1/Phase 2France
308NCT02212249
(ClinicalTrials.gov)
May 201423/4/2014Soluble 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, GrenobleNULLCompleted18 YearsN/ABoth85N/AFrance
309EUCTR2013-003200-39-GB
(EUCTR)
01/04/201404/04/2014Investigation of Zibotentan for kidney disease in sclerodermaA phase II, single centre, randomised, placebo-controlled, 3-part trial to assess the safety, tolerability and efficacy of Zibotentan in patients with renal disease secondary to scleroderma - Zibotentan better renal scleroderma outcome study (ZEBRA) Renal complications of systemic sclerosis (scleroderma renal crisis and chronic kidney disease).
MedDRA version: 16.1;Level: LLT;Classification code 10064848;Term: Chronic kidney disease;System Organ Class: 100000004857
MedDRA version: 16.1;Level: PT;Classification code 10061087;Term: Connective tissue disorder;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.1;Classification code 10018124;Term: Generalized scleroderma;Classification code 10069339;Term: Acute kidney injury;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Zibotentan
Product Code: ZD4054
INN or Proposed INN: Zibotentan
University College LondonNULLNot Recruiting Female: yes
Male: yes
72 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
310JPRN-UMIN000015495
2014/04/0122/10/2014Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapiesOsaka UniversityNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not applicableJapan
311EUCTR2013-004596-12-IT
(EUCTR)
22/01/201413/12/2013Infusion at home ,using a pump device, of a drug that dilates peripheral blood vessels to treat patients affected by a disease named Systemic sclerosis, with manifestations caused by a reduced blood flow in hands and feet.HOME INFUSION THERAPY WITH ILOPROST USING A PORTABLE SYRINGE PUMP FOR THE TREATMENT OF PERIPHERAL ULCERS AND RAYNAUD'S PHENOMENON IN SYSTEMIC SCLEROSIS. - iloporta Raynaud's phenomenon and acral ulcers in systemic sclerosis;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Trade Name: Endoprost
Product Name: Endoprost
Azienda ospedaliera universitaria Ospedali RiunitiNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Italy
312EUCTR2010-022710-77-CZ
(EUCTR)
06/01/201402/02/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Germany;Bulgaria;Denmark;Australia;Croatia;Poland;Canada;Czech Republic;Hungary;France;India;United Kingdom;Italy;Colombia;Chile;Russian Federation;Ukraine;Finland;Belarus
313NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction 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 PharmaCompleted18 YearsN/AAll81Phase 2France
314JPRN-jRCTs031180370
12/11/201318/03/2019Clinical trial of tocilizumab for skin fibrosis in systemic sclerosisClinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six monthsYoshizaki AyumiSato ShinichiComplete>= 20age old< 80age oldBoth5Phase 2Japan
315JPRN-UMIN000012214
2013/11/0505/11/2013Clinical trial of tocilizumab for skin fobrosis in systemic sclerosisClinical trial of tocilizumab for skin fobrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
The University of TokyoNULLComplete: follow-up complete20years-old80years-oldMale and Female5Not applicableJapan
316EUCTR2012-003633-42-GB
(EUCTR)
18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
317EUCTR2013-001353-28-IT
(EUCTR)
04/10/201304/07/2013An 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 - LOTUSS Systemic Sclerosis-Related Interstitial Lung Disease;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Esbriet
INN or Proposed INN: PIRFENIDONE
InterMune Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Canada;Italy
318NCT01933334
(ClinicalTrials.gov)
October 201323/8/2013Safety 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.NULLCompleted18 Years75 YearsAll63Phase 2United States;Canada;Italy
319EUCTR2012-004955-35-IT
(EUCTR)
29/07/201330/05/2013A 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: MabtheraPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
320JPRN-JapicCTI-132176
01/6/2013Bosentan DUA prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc) Digital ulcers associated with systemic sclerosisIntervention name : Ro47-0203 / ACT-050088
INN of the intervention : Bosentan
Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5.
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.NULL18BOTH20Phase 3NULL
321NCT01878526
(ClinicalTrials.gov)
June 20137/6/2013Gastroesophageal 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 UniversityNULLCompleted18 Years65 YearsAll80Phase 3Thailand
322NCT03561233
(ClinicalTrials.gov)
May 20137/6/2018Prevalence 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 AssociationCompleted18 YearsN/AAll250Phase 1NULL
323NCT01804959
(ClinicalTrials.gov)
May 20133/3/2013Clinical 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 HospitalNULLUnknown status18 YearsN/AAll40Phase 2Singapore
324NCT01748084
(ClinicalTrials.gov)
April 9, 201310/12/2012Rituximab in Systemic SclerosisEvaluation of Rituximab in Systemic Sclerosis Associated PolyarthritisSystemic SclerosisDrug: Rituximab;Drug: Placebo (NaCl)Assistance Publique - Hôpitaux de ParisNULLCompleted18 Years80 YearsAll22Phase 2/Phase 3France
325NCT01785056
(ClinicalTrials.gov)
April 201328/1/2013IVIG 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 BehringUnknown status18 YearsN/AAll14N/AUnited States
326NCT02002897
(ClinicalTrials.gov)
April 20135/9/2013Fractional Carbon Dioxide Laser Versus UVA 1 in Treatment of Localized SclerodermaFractional Carbon Dioxide Laser Versus UVA1 Phototherapy for Treatment of Localized Scleroderma: A Clinical & Immunohistochemical Comparative StudyLocalized SclerodermaDevice: Fractional carbon dioxide laser;Device: Ultraviolet A1 phototherapy (UVA1)Cairo UniversityNULLRecruitingN/AN/ABoth20N/AEgypt
327EUCTR2012-005348-92-IT
(EUCTR)
19/02/201311/01/2013PROGASS PRucalopride On the GAstreonteric transit in Systemic SclerosisPROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis - PROGASS Sysemic sclerosis with gastroenteric involvement (constipation)
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: RESOLOR*28CPR RIV 2MG
INN or Proposed INN: PRUCALOPRIDE SUCCINATE
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
Italy
328EUCTR2012-001369-34-IT
(EUCTR)
12/02/201321/12/2012Proof of biological activity of SAR100842 in Systemic SclerosisDouble-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis Systemic Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: NA
Product Code: SAR100842
Product Name: NA
Product Code: SAR100842
SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
30United States;Canada;Germany;United Kingdom;Switzerland;Italy
329NCT01570764
(ClinicalTrials.gov)
January 14, 20132/4/2012Cyclophosphamide 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-HuriezCompleted18 YearsN/AAll40Phase 3France
330NCT01651143
(ClinicalTrials.gov)
January 201324/7/2012Proof of Biological Activity of SAR100842 in Systemic SclerosisDouble-blind, Randomized, Placebo-controlled, 8-week Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic SclerosisSystemic SclerosisDrug: SAR100842;Drug: PlaceboSanofiNULLCompleted18 YearsN/ABoth30Phase 2United States;France;Italy;Switzerland;United Kingdom;Germany
331EUCTR2012-001369-34-DE
(EUCTR)
19/11/201217/08/2012Proof of biological activity of SAR100842 in Systemic SclerosisInitial title : Double-blind, randomized, placebo-controlled, 8-week study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic SclerosisRevised title according to the protocol amendment 4 :Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis Systemic Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: SAR100842
Product Code: SAR100842
Sanofi-aventis recherche & développementNULLNot RecruitingFemale: yes
Male: yes
30United States;Canada;Germany;United Kingdom;Switzerland
332EUCTR2012-001369-34-GB
(EUCTR)
26/10/201215/06/2012Proof 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 Sclerosis Systemic Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Code: SAR100842
Product Code: SAR100842
Sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;Italy;Switzerland;United Kingdom
333NCT02169752
(ClinicalTrials.gov)
September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
334NCT01895244
(ClinicalTrials.gov)
September 20121/7/2013Autologous 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 TuebingenNULLRecruiting18 Years65 YearsAll44Phase 2Germany
335NCT01559129
(ClinicalTrials.gov)
August 9, 201219/3/2012Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial 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 DiseaseScleroderma, Systemic;Sclerosis, Systemic;Systemic Scleroderma;Systemic Sclerosis;Interstitial Lung DiseaseDrug: Pomalidomide (CC-4047);Drug: PlaceboCelgeneNULLTerminated18 Years80 YearsAll23Phase 2United States;Australia;France;Germany;Italy;Poland;Russian Federation;Spain;Switzerland;United Kingdom
336NCT01670565
(ClinicalTrials.gov)
August 201215/8/2012Belimumab 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.Completed18 YearsN/AAll20Phase 2United States
337EUCTR2010-023047-15-PL
(EUCTR)
17/07/201214/05/2012A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Poland;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland
338EUCTR2010-022710-77-PL
(EUCTR)
30/05/201212/03/2012A 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-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
339EUCTR2010-022969-95-PL
(EUCTR)
30/05/201212/03/2012A 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 scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
340JPRN-jRCTs031180373
14/05/201218/03/2019Clinical 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 sclerosis Interstitial lung disease secondary to systemic sclerosisRituximab 375mg/m2 once a week/4 timesYoshizaki AyumiSato ShinichiSuspended>= 20age old< 80age oldBoth60Phase 2Japan
341JPRN-UMIN000007702
2012/04/2624/04/2012Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis Interstitial lung disease secondary to systemic sclerosisRituximab(+)
30weeks
375mg/m2
once a week
4 times
Department of Dermatology, University of TokyoNULLRecruiting20years-old80years-oldMale and Female20Not selectedJapan
342EUCTR2010-022710-77-IT
(EUCTR)
11/04/201209/02/2012A 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-1 (Digital Ulcers with mAcitentan in systemic scLerosis) Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA
ACTELION PHARMACEUTICALS LTD.NULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
343EUCTR2010-022969-95-GR
(EUCTR)
02/04/201228/03/2012A 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 scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
344EUCTR2011-002434-40-DE
(EUCTR)
23/03/201218/08/2011Transplantation 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 sclerosisModification according to manifestation - AST-MOMA Systemic sclerosis
MedDRA version: 14.1;Level: LLT;Classification code 10059040;Term: Autologous peripheral haematopoietic stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: CD34 selected autologous hematopoietic cells
Product Code: CD34+SC
University Hospital TuebingenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
345EUCTR2010-023047-15-IT
(EUCTR)
20/03/201228/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease Diffuse cutaneous systemic sclerosis with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
Other descriptive name: Pomalidomide
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Poland;Spain;Australia;Germany;United Kingdom;Italy
346EUCTR2010-023047-15-DE
(EUCTR)
15/03/201208/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2 Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 16.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
347EUCTR2010-023047-15-GB
(EUCTR)
08/03/201215/12/2011A study to see if pomalidomide is safe and works to treat patients with sclerosis affecting the skin on the whole body and that also have lung diseaseA Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Systemic Sclerosis with Interstitial Lung Disease systemic sclerosis associated with interstitial lung disease
MedDRA version: 17.0;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Imnovid 1 mg hard capsules
INN or Proposed INN: Pomalidomide
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
348EUCTR2011-005303-32-NL
(EUCTR)
05/03/201226/01/2012The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II)Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II) - HOME II Digital Ulcera in Systemic Sclerodermia patients
MedDRA version: 14.1;Level: PT;Classification code 10053400;Term: Endothelin increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Tracleer
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals Nederland bvNULLNot RecruitingFemale: yes
Male: yes
Netherlands
349EUCTR2010-023047-15-ES
(EUCTR)
02/03/201219/01/2012A 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 Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease diffuse cutaneous systemic sclerosis associated with interstitial lung disease
MedDRA version: 14.1;Level: LLT;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Pomalidomida
Product Code: CC-4047
INN or Proposed INN: Pomalidomida
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Germany;Italy;United Kingdom;Switzerland;Sweden
350NCT01553981
(ClinicalTrials.gov)
March 201211/3/2012A Trial of Tadalafil in Interstitial Lung Disease of SclerodermaA Double Blind Randomized Control Trial of Tadalafil in Interstitial Lung Disease of SclerodermaLung Diseases, InterstitialDrug: Tadalafil;Drug: PlaceboSanjay Gandhi Postgraduate Institute of Medical SciencesNULLCompleted18 Years70 YearsBoth40Phase 3India
351NCT02562079
(ClinicalTrials.gov)
March 201229/12/2014Vasculopathy, 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 RhumatologieCompleted18 Years75 YearsAll350N/AFrance
352NCT01532869
(ClinicalTrials.gov)
March 201210/2/2012A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic SclerosisA Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic SclerosisSclerosis, SystemicDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll87Phase 3United States;Canada;France;Germany;United Kingdom
353EUCTR2010-022969-95-NL
(EUCTR)
27/02/201212/12/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
354EUCTR2010-022969-95-PT
(EUCTR)
03/02/201212/12/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Portugal;Greece;Spain;New Zealand;Netherlands;Germany;South Africa;Poland;Belgium;Argentina;Puerto Rico;Mexico;United Kingdom;Colombia;Russian Federation;Turkey;Ireland;Ukraine
355NCT01497743
(ClinicalTrials.gov)
February 201220/12/2011Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic SclerosisProbiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic SclerosisSclerodermaDrug: LactobacillusUniversity of MichiganNULLWithdrawn18 YearsN/ABoth0Phase 4United States
356NCT01554540
(ClinicalTrials.gov)
February 20127/2/2012Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic StudyPharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the FingersScleroderma, SystemicDrug: Cutaneous iontophoresis of treprostinilUniversity Hospital, GrenobleNULLActive, not recruiting18 YearsN/ABoth40Phase 1/Phase 2France
357EUCTR2011-001460-22-GB
(EUCTR)
19/01/201217/10/2011A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A Systemic Sclerosis (SSc)
MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Germany;United Kingdom
358EUCTR2010-022969-95-BE
(EUCTR)
16/01/201229/11/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Phase 3Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
359EUCTR2010-022710-77-FI
(EUCTR)
10/01/201207/12/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot 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
360EUCTR2010-022969-95-GB
(EUCTR)
21/12/201127/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Phase 3Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
361EUCTR2010-022969-95-IE
(EUCTR)
07/12/201131/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
362NCT01474122
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisDigital UlcersDrug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: PlaceboActelionNULLTerminated18 YearsN/AAll265Phase 3United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom
363NCT01538719
(ClinicalTrials.gov)
December 201121/2/2012IL1-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 PharmaceuticalsCompleted18 YearsN/AAll24Phase 1/Phase 2United States
364NCT01487551
(ClinicalTrials.gov)
December 20116/12/2011An 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 SclerosisDrug: paquinimodActive Biotech ABNULLCompleted18 YearsN/ABoth9Phase 2Germany;Sweden;Switzerland
365NCT01474109
(ClinicalTrials.gov)
December 201131/10/2011Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis PatientsProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic SclerosisSystemic Sclerosis;UlcersDrug: macitentan 3mg;Drug: macitentan 10mg;Drug: placeboActelionNULLCompleted18 YearsN/AAll289Phase 3United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine
366EUCTR2011-001460-22-DE
(EUCTR)
28/11/201120/10/2011A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A Systemic Sclerosis (SSc)
MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: RoActemra
Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
86Phase 2/3France;United States;Canada;Germany;United Kingdom
367EUCTR2010-022710-77-BG
(EUCTR)
17/11/201126/08/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
368NCT02240888
(ClinicalTrials.gov)
October 20114/9/2014Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody ResponseRA;SLE;Vasculitis;Scleroderma;Sjögrens;SyndromeBiological: 0,5 mg Prevenar i.m.;Biological: 0,5 mg seasonal influenza vaccine i.m.Region SkaneNULLCompleted18 YearsN/AAll300N/ASweden
369EUCTR2011-001667-44-DE
(EUCTR)
28/09/201126/09/2011A study to evaluate biomarkers and safety in scleroderma patients treated with ABR-215757 (paquinimod)An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod) Systemic Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: paquinimod
Product Code: ABR-215757
INN or Proposed INN: paquinimod
Active Biotech ABNULLNot RecruitingFemale: yes
Male: yes
20Germany;Switzerland;Sweden
370NCT01445821
(ClinicalTrials.gov)
September 15, 201129/9/2011Autologous 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 UniversityNULLTerminated17 Years60 YearsAll44Phase 3United States
371NCT01413100
(ClinicalTrials.gov)
September 15, 20118/8/2011Scleroderma 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)Active, not recruitingN/A70 YearsAll21Phase 2United States;Canada
372EUCTR2010-022969-95-DE
(EUCTR)
09/08/201131/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
285Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
373EUCTR2011-001667-44-SE
(EUCTR)
28/06/201118/05/2011An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod)An open-label study to evaluate biomarkers and safety in systemic sclerosis patients treated with ABR-215757 (paquinimod) Systemic Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: paquinimod
Product Code: ABR-215757
INN or Proposed INN: paquinimod
Active Biotech ABNULLNot RecruitingFemale: yes
Male: yes
20Germany;Switzerland;Sweden
374NCT01086540
(ClinicalTrials.gov)
June 24, 201111/3/2010Rituximab 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 Excellence;Rho Federal Systems Division, Inc.Completed18 Years75 YearsAll57Phase 2United States
375EUCTR2010-022710-77-DE
(EUCTR)
16/06/201131/01/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot 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
376JPRN-UMIN000005550
2011/06/0123/05/2011Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis Systemic sclerosisAdministrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Continue existing conventional therapies
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of MedicineRheumatology Keio University,Rheumatology Tokyo Women's Medical University,Dermatology Osaka UniversityComplete: follow-up complete20years-old65years-oldMale and Female24Phase 2Japan
377EUCTR2010-022969-95-ES
(EUCTR)
26/05/201118/11/2011A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis. Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: 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
378NCT01257802
(ClinicalTrials.gov)
May 20119/12/2010GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesGnRH-a for Ovarian Protection During CYC Therapy for Rheumatic DiseasesLupus Erythematosus, Systemic;Systemic Vasculitis;Isolated Angiitis of Central Nervous System;Lung Disease With Systemic Sclerosis;Lung Disease Interstitial DiffuseDrug: depot leuprolide acetate 3.75 mg;Drug: PlaceboJoseph MccuneNational Institutes of Health (NIH);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Terminated18 Years40 YearsFemale14Phase 3United States
379NCT01639573
(ClinicalTrials.gov)
April 201118/6/2012Campath-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 AngelesNULLWithdrawn8 Years18 YearsAll0Phase 1/2United States
380NCT01347008
(ClinicalTrials.gov)
April 20112/5/2011Effect 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 PauloCompleted18 YearsN/AFemale41Phase 3Brazil
381EUCTR2010-022710-77-DK
(EUCTR)
22/03/201103/02/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
382EUCTR2010-024005-13-GB
(EUCTR)
11/03/201130/12/2010A study of ORM-12741 for the prevention of blood vessel spasm brought on by cold temperature.Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-controlled, single centre crossover study in patient with Raynaud's phenomenon secondary to systemic sclerosis - Reino Raynaud's phenomenon secondary to systemic sclerosis (Raynaud's syndrome)
MedDRA version: 14.0;Level: LLT;Classification code 10037914;Term: Raynaud's syndrome;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: alpha-2C AR antagonist
Product Name: ORM-12741
Product Code: ORM-12741
Other descriptive name: Alpha-2C AR antagonist
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
383NCT01309997
(ClinicalTrials.gov)
March 20111/3/2011Imatinib 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)Completed2 YearsN/AAll72Phase 2United States
384NCT01315899
(ClinicalTrials.gov)
March 201114/3/2011Efficacy 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 PharmaNULLTerminated18 Years75 YearsBoth15Phase 2United Kingdom
385NCT01395732
(ClinicalTrials.gov)
March 20116/7/2011Bosentan 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: BosentanActelionNULLCompleted18 YearsN/ABoth18Phase 4Netherlands
386EUCTR2010-022710-77-HU
(EUCTR)
28/02/201101/02/2011A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
295United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
387NCT01284322
(ClinicalTrials.gov)
January 201125/1/2011Fresolimumab In Systemic SclerosisOPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIALDiffuse Systemic SclerosisDrug: FresolimumabBoston UniversityNULLCompleted18 YearsN/ABoth18Phase 1United States
388NCT01241383
(ClinicalTrials.gov)
December 201012/11/2010Effect of Bosentan in Scleroderma Renal CrisisEffect of Bosentan in the Course of Scleroderma Renal CrisisScleroderma Renal CrisisDrug: BosentanAssistance Publique - Hôpitaux de ParisActelionCompleted18 YearsN/ABoth16Phase 2France
389EUCTR2010-019977-14-IT
(EUCTR)
04/11/201027/12/2010Efficacy 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 - ND Patients affected by Systemic Sclerosis with Raynaud’s Phenomenon
MedDRA version: 9.1;Level: LLT;Classification code 10042953
Trade Name: PLETAL
INN or Proposed INN: CILOSTAZOL
AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
390EUCTR2009-018194-31-GB
(EUCTR)
03/11/201018/03/2010Topical Amlodipine in Raynaud's PhenomenonTopical Amlodipine in Raynaud's Phenomenon The medical conditions under investigation in this trial are as follows:1] Primary Raynaud's Phenomenon2] Systemic Sclerosis (SSc) - otherwise known an Seconday Raynaud's Phenomenon.Raynaud's phenomenon is a disorder that affects the blood vessels in the fingers, toes, ears, and nose. This disorder is characterized by episodic attacks, called vasospastic attacks, that cause the blood vessels in the digits (fingers and toes) to constrict (narrow).Product Name: Amlodipine Gel
Product Code: AM-01
Pharmarama International LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45United Kingdom
391NCT01295736
(ClinicalTrials.gov)
November 201011/2/2011Sildenafil 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, LilleNULLCompleted18 YearsN/ABoth84Phase 3France
392EUCTR2009-013468-37-GB
(EUCTR)
29/09/201017/03/2010A 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 phenomenon Primary Raynaud's Phenomenon and Systemic Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10042953;Term: Systemic Sclerosis
MedDRA version: 12.0;Classification code 10037917;Term: Raynaud's phenomenon
Trade Name: Asasantin Retard ®
Product Name: ASASANTIN Retard
INN or Proposed INN: aspirin
INN or Proposed INN: dipyridamole
Royal National Hospital for Rheumatic DiseaseNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
393EUCTR2009-017869-27-DE
(EUCTR)
23/09/201014/07/2010A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis.A dual-center, open-label Proof of Concept study to evaluate the efficacy of Terguride for the treatment of fibrosis in patients with systemic sclerosis. Diffuse scleroderma
MedDRA version: 12.1;Level: LLT;Classification code 10012941;Term: Diffuse scleroderma
Product Name: Terguride
Product Code: PR1
INN or Proposed INN: Terguride
Other descriptive name: transdihydrolisuride
University Hospital ZurichNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
14Germany
394EUCTR2010-021452-26-FR
(EUCTR)
20/09/201009/07/2010Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBOCrise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO Les patients inclus dans l'étude seront des patients atteints de sclérodermie systémique (définie selon les critères de la classification de l'ACR et/ou de Leroy et Medsger) et présentant une crise rénale sclérodermique aigue définie par une HTA sévère d'emblée et/ou d'aggravation progressive >150/85mmHg obtenue à deux reprises minimum en 24H, sans autre explication que la ScS et/ou une insuffisance rénale rapidement progressive, sans autre explication que la ScS.
MedDRA version: 8.1;Level: PT;Classification code 10062553;Term: scleroderma renal crisis
Trade Name: Tracleer
Product Name: Tracleer
INN or Proposed INN: bosentan
Trade Name: Tracleer
Product Name: Tracleer
INN or Proposed INN: Bosentan
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
Phase 3France
395JPRN-UMIN000031940
2010/09/0728/03/2018Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis Systemic sclerosisCyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
Kyushu UniversityNULLComplete: follow-up complete16years-old65years-oldMale and Female24Phase 2Japan
396JPRN-UMIN000004162
2010/09/0105/09/2010The efficacy of Mizoribine for scleroderma of systemic sclerosis. systemic sclerosisa group of Mizoribine
a group of the existing treatment
Faculty of Life Sciences, Kumamoto UniversityNULLRecruitingNot applicableNot applicableMale and Female10Not selectedJapan
397NCT01166139
(ClinicalTrials.gov)
July 20101/7/2010Nilotinib 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 PharmaceuticalsCompleted18 YearsN/AAll10Phase 2United States
398NCT02339441
(ClinicalTrials.gov)
June 201022/12/2014Treatment 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 ManchesterNULLCompleted18 YearsN/ABoth320N/ANULL
399NCT01151644
(ClinicalTrials.gov)
April 201025/6/2010Safety 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 PauloActive, not recruitingN/AN/ABoth5000Phase 4Brazil
400EUCTR2008-001265-28-IT
(EUCTR)
02/03/201007/12/2009Open 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 - NDOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - ND skin fibrosis of systemic sclerosis patients
MedDRA version: 12.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144. Cytokines Inhibitors
Product Code: P144
INN or Proposed INN: P144 Cytokines Inhibitors
ISDIN S.A.NULLNot RecruitingFemale: yes
Male: yes
98Hungary;United Kingdom;Germany;Spain;Italy
401NCT00946699
(ClinicalTrials.gov)
March 201023/7/2009A Study of the Safety and Tolerability of MEDI-551 in SclerodermaA Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in SclerodermaSclerodermaBiological: MEDI-551;Biological: Placebo;Other: PlaceboMedImmune LLCNULLCompleted18 YearsN/ABoth50Phase 1United States;Canada;United Kingdom
402NCT01093885
(ClinicalTrials.gov)
February 201024/3/2010Study 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 SciencesCompleted19 Years90 YearsAll15N/AUnited States
403NCT01072669
(ClinicalTrials.gov)
February 201019/2/2010Efficacy 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 SciencesCompleted18 Years70 YearsAll20N/AUnited States
404NCT01374282
(ClinicalTrials.gov)
January 201014/6/2011Post Marketing Surveillance Study of CupriminePost Marketing Surveillance Study of Cuprimine (MK-0172-001)SclerodermaDrug: Cuprimine (penicillamine)Merck Sharp & Dohme Corp.NULLNo longer availableN/AN/ABothN/ANULL
405NCT01042158
(ClinicalTrials.gov)
January 20104/1/2010A 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 UniversityCompleted18 YearsN/AAll25Phase 4United States
406NCT01047072
(ClinicalTrials.gov)
January 201011/1/2010Low-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)Withdrawn18 Years65 YearsBoth0Phase 2United States
407NCT01586663
(ClinicalTrials.gov)
January 201025/4/2012Serial 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 PauloNULLRecruiting18 YearsN/ABoth76Phase 3Brazil
408NCT01002508
(ClinicalTrials.gov)
November 200926/10/2009Influenza Vaccination in Patients With SclerodermaSafety and Efficacy of Vaccination Against Influenza in Patients With SclerodermaInfluenza Vaccine in SclerodermaBiological: Influenza vaccineTel-Aviv Sourasky Medical CenterNULLNot yet recruiting16 Years90 YearsBoth80Phase 4Israel
409NCT01117298
(ClinicalTrials.gov)
November 20093/5/2010A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in SclerodermaA Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric StudyRaynaud's Phenomenon;Digital Ulcers;SclerodermaDrug: Tadalafil;Drug: PlaceboSanjay Gandhi Postgraduate Institute of Medical SciencesInstitute of Postgraduate Medical Education and Research;Postgraduate Institute of Medical Education and Research;Army Research and Referral hospitalCompleted18 Years65 YearsBoth66Phase 3India
410NCT00883129
(ClinicalTrials.gov)
September 200916/4/2009Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: PlaceboMichael RothNational Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La RocheCompleted18 YearsN/AAll142Phase 2United States
411NCT00930683
(ClinicalTrials.gov)
September 200929/6/2009A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With SclerodermaA Phase 1 Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Single and Multiple Intravenous Doses of MEDI-546, a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor, in Adult Subjects With SclerodermaSclerodermaDrug: MEDI-546MedImmune LLCNULLCompleted18 YearsN/ABoth34Phase 1United States
412NCT00848107
(ClinicalTrials.gov)
September 200916/2/2009Open-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 TherapeuticsNULLTerminated18 YearsN/AAll115Phase 2United States;Canada;United Kingdom
413NCT00962923
(ClinicalTrials.gov)
August 200919/8/2009Allogeneic 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 SchoolNULLRecruiting15 Years65 YearsBoth20Phase 1/Phase 2China
414EUCTR2007-002015-38-IT
(EUCTR)
05/06/200919/06/2009Phase 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. - NDPhase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis. - ND Skin Fibrosis in patients with systemic sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144ISDIN S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
415NCT00936546
(ClinicalTrials.gov)
June 20099/7/2009A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and EfficacyA Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and EfficacyDebilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)Drug: RituximabUniversity Hospital, GhentNULLCompleted18 YearsN/AAll3Phase 2Belgium
416EUCTR2008-007180-16-NL
(EUCTR)
13/05/200924/11/2008INFLUENCE 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
LUMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
417NCT00775463
(ClinicalTrials.gov)
May 200917/10/2008Digital 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 TherapeuticsNULLCompleted18 YearsN/AAll148Phase 2United States;Canada;United Kingdom
418EUCTR2007-003621-24-AT
(EUCTR)
30/03/200923/04/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
419EUCTR2008-006978-15-GB
(EUCTR)
05/03/200922/05/2009DISTOL-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-EXT Systemic Sclerosis, scleroderma digital ulcers
MedDRA version: 14.0;Level: PT;Classification code 10039710;Term: Scleroderma;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C-SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15 SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
450United Kingdom;Canada;United States
420EUCTR2008-005018-39-GB
(EUCTR)
05/03/200922/05/2009DISTOL-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-1 Systemic Sclerosis, scleroderma digital ulcers
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C SR
INN or Proposed INN: treprostinil diethanolamine
Product Name: treprostinil diethanolamine
Product Code: UT-15C-SR
INN or Proposed INN: treprostinil diethanolamine
United Therapeutics CorporationNULLNot RecruitingFemale: yes
Male: yes
150United Kingdom
421NCT01051960
(ClinicalTrials.gov)
March 200919/1/2010Exercise 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 SciencesCompleted18 Years80 YearsAll12Phase 4United States
422NCT00573326
(ClinicalTrials.gov)
February 200913/12/2007Low-Dose Oral Imatinib for Scleroderma Pulmonary InvolvementLow-Dose Oral Imatinib in the Treatment of Scleroderma Pulmonary Involvement: A Phase II Pilot StudySystemic SclerosisDrug: ImatinibAzienda Ospedaliera Universitaria PoliclinicoUniversità Politecnica delle MarcheRecruiting18 Years80 YearsBoth30Phase 2Italy
423NCT00764309
(ClinicalTrials.gov)
January 20091/10/2008Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary FibrosisAn Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial FibrosisSclerodermaDrug: dasatinibBristol-Myers SquibbNULLCompleted18 YearsN/AAll47Phase 1/Phase 2United States
424EUCTR2007-004669-17-IT
(EUCTR)
17/12/200816/06/2008A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis - NDA multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis - ND sistemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10018124;Term: Generalized scleroderma
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESILATO
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
27United Kingdom;Italy
425EUCTR2007-003621-24-GB
(EUCTR)
02/12/200814/07/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
426NCT00769028
(ClinicalTrials.gov)
December 20087/10/2008AIMSPRO 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 LimitedNULLActive, not recruiting18 YearsN/ABoth20Phase 2United Kingdom
427NCT00848939
(ClinicalTrials.gov)
December 200819/2/2009Pharmacokinetics 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 TherapeuticsNULLCompleted18 YearsN/ABoth28Phase 1United States
428EUCTR2008-001265-28-GB
(EUCTR)
14/11/200819/08/2008Open 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 - OLEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis - OLE Skin fibrosis in patients with systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144. Cytokines Inhibitors
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Hungary;Germany;United Kingdom;Spain;Italy
429NCT00442611
(ClinicalTrials.gov)
November 20081/3/2007A 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 SquibbCompleted18 YearsN/AAll10Phase 1/Phase 2United States
430EUCTR2006-004598-83-GB
(EUCTR)
22/10/200824/10/2008High 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) - ASTIS Severe systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: Neupogen
Product Name: Filgrastim
INN or Proposed INN: FILGRASTIM
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
Product Code: rbATG
INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit
Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS
Trade Name: Solu-Medrone
Product Name: Methylprednisolone
INN or Proposed INN: METHYLPREDNISOLONE
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: Mesna
Product Name: Mesna
INN or Proposed INN: MESNA
Trade Name: Mesna
Product Name: Mesna
INN or Proposed INN: MESNA
EBMT (European group for Blood and Marrow Transplantation)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150United Kingdom
431EUCTR2008-000224-27-GB
(EUCTR)
15/10/200807/08/2008Systemic 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 disease Systemic Sclerosis associated interstitial lung disease
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Solu-medrone
Product Name: methylprednisolone
INN or Proposed INN: METHYLPREDNISOLONE
Product Name: cyclophosphamide
Product Code: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Newcastle upon Tyne NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
20Phase 4United Kingdom
432EUCTR2008-001265-28-DE
(EUCTR)
13/10/200819/05/2008OFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLEOFFENE (UNVERBLINDETE) VERLÄNGERUNGSTUDIE FÜR PATIENTEN AUS DER ISD002-P144-07 STUDIE MIT TOPISCH AUFGETRAGENEM P144 AUF HAUTFIBROSEN BEI PATIENTEN MIT SYSTEMISCHER SKLEROSEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE Skin fibrosis in patients with systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144 Cytokine Inhibitor
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Hungary;Spain;Germany;Italy;United Kingdom
433EUCTR2008-001265-28-HU
(EUCTR)
18/09/200805/08/2008Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLEOpen Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.Az ISD002-P144-07 vizsgálat nyílt kiterjesztése P144-gyel kezelt, szisztémás szklerózisban szenvedo betegek felületi borfibrózisának kezelésében. - OLE Skin fibrosis in patients with systemic sclerosis.Szisztémás szklerózisban szenvedo betegek.
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144 Cytokines Inhibitors
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Hungary;United Kingdom;Germany;Spain;Italy
434NCT00984932
(ClinicalTrials.gov)
September 200824/9/2009Effect 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 AlexandriaNULLCompletedN/AN/ABoth40Phase 3Egypt
435EUCTR2005-003775-21-GB
(EUCTR)
14/08/200810/11/2005Effects 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 sclerosis Systemic sclerosis (also termed 'scleroderma')Trade Name: Lipitor
Product Name: Lipitor
Salford Royal Hospitals NHS TrustUniversity of ManchesterNot Recruiting Female: yes
Male: yes
36 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
436EUCTR2007-003621-24-NL
(EUCTR)
23/07/200813/03/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
437EUCTR2007-003621-24-IT
(EUCTR)
15/07/200817/11/2008Double-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 - NDDouble-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
MONDOGEN AGNULLNot RecruitingFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
438EUCTR2007-004669-17-DE
(EUCTR)
10/07/200813/03/2008A multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosisA multi-centre, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Glivec 100 mg Filmtabletten
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
27Germany;Italy;United Kingdom
439NCT00781053
(ClinicalTrials.gov)
July 200824/10/2008Open Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 StudyOpen Label Extension (OLE) for the Patients Treated in the ISD002-P144-07 Study With P144 Topical Adminsitration for Skin Fibrosis in Patients With Systemic SclerosisSkin FibrosisDrug: P144 creamISDINDigna Biotech S.L.Completed18 Years65 YearsBoth38Phase 2Germany;Hungary;Italy;Poland;Spain;United Kingdom
440EUCTR2007-003621-24-BE
(EUCTR)
20/06/200808/01/2008Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
441EUCTR2008-001265-28-ES
(EUCTR)
17/06/200808/04/2008Estudio 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” - OLEEstudio abierto de extensión con P144 para la ampliación del tratamiento tópico de la fibrosis cutánea de pacientes con esclerosis sistémica previamente tratados en el ensayo ISD002-P144-07 Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis” - OLE Fibrosis cutánea de pacientes con esclerosis sistémicaSkin fibrosis in patients with systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144. Cytokines Inhibitors
INN or Proposed INN: P144
Other descriptive name: DIGNA P144 cream
ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Hungary;United Kingdom;Germany;Spain;Italy
442NCT00725361
(ClinicalTrials.gov)
June 200828/7/2008A 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 UniversityNULLCompleted18 YearsN/AAll20N/AUnited States
443EUCTR2007-003621-24-FR
(EUCTR)
29/05/200827/12/2007Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
444EUCTR2007-003122-24-GB
(EUCTR)
09/04/200815/02/2008A 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 sclerosis Diffuse Cutaneous Systemic Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis
MedDRA version: 9.1;Classification code 10036814;Term: Progressive systemic sclerosis
MedDRA version: 9.1;Classification code 10039710;Term: Scleroderma
MedDRA version: 9.1;Classification code 10012941;Term: Diffuse scleroderma
MedDRA version: 9.1;Classification code 10018124;Term: Generalized scleroderma
MedDRA version: 9.1;Classification code 10042954;Term: Systemic sclerosis pulmonary
Product Name: AIMSPRODaval International LimitedNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
445NCT01545427
(ClinicalTrials.gov)
April 20081/3/2012Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse SclerodermaA Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse SclerodermaSclerodermaDrug: Imatinib mesylate;Other: PlaceboLawson Health Research InstituteNovartis PharmaceuticalsTerminated18 YearsN/ABoth10Phase 2Canada
446EUCTR2007-003621-24-DE
(EUCTR)
20/03/200813/02/2009Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP
MondoGEN AGNULLNot RecruitingFemale: yes
Male: yes
48United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria
447EUCTR2007-004669-17-GB
(EUCTR)
15/02/200816/10/2007A 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 sclerosis Skin fibrosis in systemic sclerosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Glivec
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
27United Kingdom;Italy
448NCT00613171
(ClinicalTrials.gov)
January 2, 200825/1/2008Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants 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 PharmaceuticalsNULLCompleted18 YearsN/AAll27Phase 2United States;Germany;Italy;Switzerland;United Kingdom
449NCT00909337
(ClinicalTrials.gov)
January 200827/5/2009Early Therapy of Pulmonary Arterial HypertensionEarly Therapy of Pulmonary Arterial HypertensionPulmonary Hypertension;Systemic SclerosisDrug: BosentanMedical University of GrazActelionCompleted18 Years90 YearsBoth10N/AAustria
450EUCTR2007-002015-38-DE
(EUCTR)
20/12/200703/08/2007PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Phase 2Hungary;Spain;Germany;Italy;United Kingdom
451EUCTR2007-002015-38-GB
(EUCTR)
19/12/200731/07/2007 PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144 DIGNA CREAM
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLNot Recruiting Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Spain;Germany;Italy;United Kingdom
452NCT00577304
(ClinicalTrials.gov)
December 200718/12/2007A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's PhenomenonA Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's PhenomenonRaynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Other Autoimmune DiseaseDrug: Nitroglycerin;Drug: Topical AmphiMatrixMediQuest TherapeuticsNULLActive, not recruiting15 Years70 YearsBoth200Phase 3United States
453NCT00479934
(ClinicalTrials.gov)
December 200729/5/2007Efficacy 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;NovartisCompleted18 YearsN/ABoth28Phase 2France
454NCT00581997
(ClinicalTrials.gov)
December 200721/12/2007QAX576 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 PharmaceuticalsNULLTerminated18 Years65 YearsBoth8Phase 2United States
455NCT00626665
(ClinicalTrials.gov)
December 200721/2/2008Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in SclerodermaRandomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in SclerodermaRaynaud DiseaseDrug: TadalafilSanjay Gandhi Postgraduate Institute of Medical SciencesNULLCompleted18 Years70 YearsBoth25Phase 3NULL
456EUCTR2007-006035-32-IT
(EUCTR)
15/11/200715/01/2008Assessment 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. - ND Systemic Sclerosis and Hypercholesterolemia.
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: SINVACOR*28CPR RIV 20MG
INN or Proposed INN: Simvastatin
AZIENDA OSPEDALIERA PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
457EUCTR2007-005322-68-IT
(EUCTR)
30/10/200704/10/2007Low-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 scleroderma Systemic Sclerosis
MedDRA version: 6.1;Level: PT;Classification code 10042953
Trade Name: GLIVEC
INN or Proposed INN: Imatinib
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
458EUCTR2007-001508-19-IT
(EUCTR)
06/09/200729/07/2008TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - NDTRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND GVH CRONICA ESTESA
MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease
Trade Name: GLIVEC
INN or Proposed INN: Imatinib
AZIENDA OSPEDALIERA S. CARLONULLNot RecruitingFemale: yes
Male: yes
Italy
459EUCTR2007-002015-38-HU
(EUCTR)
04/09/200709/07/2007Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében.Phase II, multicenter, randomized, double-blind, intraindividually placebo controlled clinical trial, to evaluate efficacy and safety of P144 topical administration for skin fibrosis in patients with systemic sclerosis.Fázis II, multicentrikus, randomizált, kettos vak, egyénenként placebóval kontrollált klinikai vizsgálat, különbözo koncentrációjú topikus P144 hatékonyságának és biztonságosságának megállapítása szisztémás sclerosis-ban szenvedo páciensek bor fibrózisának kezelésében. SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLNot RecruitingFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
460EUCTR2006-007091-15-NL
(EUCTR)
03/09/200702/04/2007Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosisGlivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: GlivecErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Netherlands
461NCT00574613
(ClinicalTrials.gov)
September 200713/12/2007Efficacy and Safety Study of p144 to Treat Skin Fibrosis in Systemic SclerosisPhase 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 SclerosisSkin FibrosisDrug: P144;Drug: placeboISDINDigna Biotech S.L.Completed18 Years65 YearsBoth56Phase 2Germany;Hungary;Italy;Poland;Spain;United Kingdom
462EUCTR2007-002015-38-ES
(EUCTR)
23/08/200702/07/2007ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC 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 SISTÉMICAPHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICASKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: P144
Product Code: P144
Other descriptive name: DIGNA P144 CREAM
ISDINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
98Phase 2Hungary;Germany;United Kingdom;Spain;Italy
463EUCTR2004-002799-41-GB
(EUCTR)
15/08/200729/06/2005Iontophoresis as a possible therapy for digital ischaemia - preliminary studies in patients with scleroderma spectrum disorders - Vasodilator iontophoresis as a possible therapy for digital ischaemiaIontophoresis as a possible therapy for digital ischaemia - preliminary studies in patients with scleroderma spectrum disorders - Vasodilator iontophoresis as a possible therapy for digital ischaemia Digital ischaemia/ulceration in patients with scleroderma-spectrum disordersTrade Name: NON PROPIETRY, THEREFORE N/A
Product Name: SODIUM NITROPRUSSIDE
Salford Royal Hospitals TrustUNIVERSITY OF MANCHESTERNot RecruitingFemale: yes
Male: yes
6Phase 2United Kingdom
464NCT00512902
(ClinicalTrials.gov)
August 20076/8/2007A 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 PharmaceuticalsCompleted18 YearsN/AAll20Phase 1/Phase 2United States
465NCT00555581
(ClinicalTrials.gov)
August 20077/11/2007Imatinib 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 PharmaceuticalsCompleted18 YearsN/AAll30Phase 2United States
466NCT00684255
(ClinicalTrials.gov)
August 200722/5/2008Reduced 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 CollegeNULLTerminated7 Years50 YearsAll1Phase 1United States
467NCT00506831
(ClinicalTrials.gov)
July 200724/7/2007Imatinib in Systemic SclerosisA Pilot Study of Imatinib in the Treatment of Refractory Systemic SclerosisScleroderma, SystemicDrug: Imatinib mesylateStanford UniversityNULLCompleted18 Years80 YearsAll9Phase 1/Phase 2United States
468NCT00498615
(ClinicalTrials.gov)
April 20076/7/2007A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's PhenomenonEfficacy, Tolerability and Biology of a Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's PhenomenonRaynaud;SclerodermaDrug: FasudilJohns Hopkins UniversityNULLCompleted18 Years80 YearsAll17Phase 3United States
469NCT00463125
(ClinicalTrials.gov)
March 200719/4/2007Platelet Gel in Systemic SclerosisPlatelet Gel for Digital Ulcers in Patients With SSc: a Randomized Controlled TrialScleroderma, SystemicDrug: Platelet GelUniversità Politecnica delle MarcheNULLRecruiting18 Years80 YearsBoth40Phase 2/Phase 3Italy
470JPRN-UMIN000000589
2007/02/0114/02/2007Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis systemic sclerosis (SSc)Granulocyte-colony stimulating factor (G-CSF), "Gran"Division of Rheumatology, Department of Internal Medicine, Keio University School of MedicineNULLComplete: follow-up complete18years-old70years-oldMale and Female8Phase 1,2Japan
471NCT00428883
(ClinicalTrials.gov)
January 200729/1/2007High 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 MarcheNULLRecruiting18 Years80 YearsBoth45Phase 2/Phase 3Italy
472NCT00419419
(ClinicalTrials.gov)
December 20064/1/2007Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's PhenomenonPhase III In-Life Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's PhenomenonRaynaud's Disease;Scleroderma;Autoimmune DiseasesDrug: Topical AmphiMatrix with nitroglycerin (MQX-503)MediQuest TherapeuticsNULLCompleted18 Years70 YearsBoth80Phase 3United States;Sweden;United Kingdom
473EUCTR2005-004979-37-GB
(EUCTR)
27/11/200618/09/2006 Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 Moderate to severe primary Raynaud’s, OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as sclerodermaProduct Name: MQX-503
Product Code: MQX-503
INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP
Other descriptive name: Nitroglycerine gel
MediQuest Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Sweden
474NCT00379431
(ClinicalTrials.gov)
November 200620/9/2006A 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, GhentNULLActive, not recruiting18 YearsN/ABoth40Phase 2Belgium
475EUCTR2005-004979-37-SE
(EUCTR)
27/10/200608/09/2006Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2Phase III In-Life” Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud’s Phenomenon - 06-004 A2 Moderate to severe primary Raynaud’s,OR patients with Raynaud’s phenomenon secondary to autoimmune diseases, such as sclerodermaProduct Name: MQX-503
Product Code: MQX-503
INN or Proposed INN: 10% Nitroglycerine in Propylene Glycol, USP
Other descriptive name: Nitroglycerine gel
MediQuest Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Sweden
476EUCTR2006-002081-19-NL
(EUCTR)
16/10/200621/07/2006The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic SclerosisA phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAHThe Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic SclerosisA phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH Pulmonary arterial hypertension associated with systemic sclerosisTrade Name: Erbitux
Product Name: Cetuximab
Product Code: C225
VU University Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Netherlands
477EUCTR2006-003957-25-IT
(EUCTR)
13/10/200609/07/2007Rare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SScRare Diseases with microvascular involvement. High Dose Intravenous N-acetylcysteine versus Iloprost for early, rapidlyprogressive diffuse Systemic Sclerosis (Scleroderma) - N-Acetylcisteine vs Iloprost in SSc Systemic Scleroderma
MedDRA version: 9.1;Level: LLT;Classification code 10055953;Term: Scleroedema
Trade Name: HIDONAC*EV 1FL 5G 25ML
INN or Proposed INN: Acetylcysteine
Trade Name: ENDOPROST 50*INFUS 1F 0,050MG/
INN or Proposed INN: Iloprost
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
478EUCTR2006-003836-31-BE
(EUCTR)
06/09/200602/08/2006A 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) rituximab systemic sclerosis
MedDRA version: 8.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
University Hospital GentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
479NCT00622895
(ClinicalTrials.gov)
September 1, 200622/2/2008Allogeneic 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)CompletedN/A70 YearsAll3Phase 1/Phase 2United States
480NCT00377455
(ClinicalTrials.gov)
September 200614/9/2006Placebo 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 UniversityActelionTerminated18 YearsN/AAll5Phase 2United States
481EUCTR2006-005230-20-IT
(EUCTR)
14/07/200612/07/2007EX 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 - ND Variazione della gravita' del fenomeno di Raynaud misurata mediante diario dei sintomi e scala analogica visiva VAS ? Visual Analogic Scale (6). Variazione dello stato globale di malattia valutata mediante HAQ ? Health Assessment Questionnaire (7).
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: CAPILLAREMAOSPEDALE MAGGIORE DI MILANO (IRCCS)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
482NCT00348296
(ClinicalTrials.gov)
July 20063/7/2006Efficacy 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 CorporationNULLCompleted16 YearsN/ABoth60Phase 3Japan
483NCT00378521
(ClinicalTrials.gov)
July 200618/9/2006Dose Response Study of a Topical Gel for the Treatment of Raynaud's PhenomenonPhase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's PhenomenonRaynaud's Disease;Raynaud's Disease Secondary to Scleroderma;Raynaud's Disease Secondary to Autoimmune DiseaseDrug: MQX-503MediQuest TherapeuticsNULLCompleted18 Years75 YearsBoth15Phase 2United States
484EUCTR2006-000905-41-AT
(EUCTR)
07/06/200608/05/2006Offene, 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 raynaud Raynaud syndrome with / without systemic sclerosisTrade Name: Ilomedin
Product Name: Ilomedin
Product Code: 1-22460
ao. Univ. Prof. Dr. Elisabeth AbererNULLNot RecruitingFemale: yes
Male: yes
Phase 4Austria
485NCT00318175
(ClinicalTrials.gov)
June 200624/4/2006Effect 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, DuesseldorfNULLCompleted18 YearsN/ABoth10Phase 2Germany
486NCT00333437
(ClinicalTrials.gov)
May 20062/6/2006Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung InvolvementPulmonary Involvement in Scleroderma: Safety and Efficacy of Mycophenolate Mofetil in Scleroderma PatientsScleroderma, SystemicDrug: Mycophenolate mofetilUniversity of California, San FranciscoRoche Pharma AGCompleted21 Years70 YearsAll7N/AUnited States
487NCT00433186
(ClinicalTrials.gov)
March 20067/2/2007Mycophenolate Mofetil in Systemic SclerosisPhase I, Open-label Study of Mycophenolate Mofetil In Systemic SclerosisDiffuse Cutaneous Systemic SclerosisDrug: Mycophenolate MofetilBoston UniversityAspreva PharmaceuticalsCompleted18 YearsN/ABoth30Phase 1United States
488EUCTR2005-000701-61-GB
(EUCTR)
29/11/200527/10/2005An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 Scleroderma renal crisisTrade Name: Tracleer
Product Name: Bosentan
Product Code: N/A
University College LondonNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):United Kingdom
489NCT00278525
(ClinicalTrials.gov)
September 200515/1/2006Cyclophosphamide 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 UniversityNULLCompletedN/A60 YearsAll19Phase 2United States
490NCT00147771
(ClinicalTrials.gov)
September 20052/9/2005Imiquimod in Children With Plaque MorpheaEvaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot StudyScleroderma, LocalizedDrug: Imiquimod 5% creamThe Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth10Phase 3Canada
491NCT00860548
(ClinicalTrials.gov)