51. 全身性強皮症
[臨床試験数:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
376 trials found
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, 202121/11/2018Skeletal 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
2NCT04647890
(ClinicalTrials.gov)
February 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 TherapeuticsNULLNot yet recruiting18 Years75 YearsAll30Phase 2NULL
3NCT04515706
(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
4NCT04627857
(ClinicalTrials.gov)
January 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, FranceNULLNot yet recruiting18 YearsN/AAll100N/ANULL
5NCT04440592
(ClinicalTrials.gov)
December 31, 202017/6/2020Study 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 Years75 YearsAll72Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-000134-17-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
7NCT04656704
(ClinicalTrials.gov)
December 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 HospitalNULLNot yet recruiting18 YearsN/AAll8Early Phase 1NULL
8NCT04303208
(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
9EUCTR2020-002081-13-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 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 2Netherlands;United Kingdom
10NCT04478994
(ClinicalTrials.gov)
November 202016/7/2020A 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-004718-32-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
12NCT04356287
(ClinicalTrials.gov)
October 202015/4/2020Treatment 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
13NCT04356755
(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
14EUCTR2020-002081-13-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
15EUCTR2019-003430-16-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-000906-31-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
17NCT04265144
(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
18NCT04244916
(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
19EUCTR2019-000906-31-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
20NCT04200755
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04523506
(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 CenterNULLRecruiting18 Years65 YearsAll30Early Phase 1United States
22ChiCTR2000031572
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
23NCT04325217
(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 (PMS) of Nintedanib (Ofev Capsule) in Systemic Scleroderma With Interstitial Lung Disease (SSc-ILD) in JapanLung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll600Japan
24ChiCTR2000030370
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
25EUCTR2019-003906-28-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]CHU de ToulouseNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
32Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-002444-24-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
27EUCTR2019-000906-31-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
28JPRN-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
29NCT03582800
(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
30NCT04138485
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03740724
(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: veledimexFibrocell Technologies, Inc.NULLRecruiting18 YearsN/AAll10Phase 1;Phase 2United States
32EUCTR2019-000906-31-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]
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 2United States;Spain;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Australia;Germany
33EUCTR2019-003203-35-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
34EUCTR2019-000906-31-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
35EUCTR2019-002036-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04040322
(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.NULLRecruiting18 YearsN/AAll180Phase 3United States
37EUCTR2019-001279-34-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]
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
30Phase 2United States;Belgium;Spain;Germany;Italy;United Kingdom
38NCT04137224
(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 BehringNULLRecruiting18 YearsN/AAll26Phase 2Australia;France;Germany;Italy;Poland;United Kingdom
39EUCTR2019-001279-34-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
40EUCTR2019-001279-34-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 NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2United States;Belgium;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-001978-22-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]
CHU de LIMOGESNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 2France
42NCT04045743
(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 SepsisNULLRecruiting18 YearsN/AAll20Phase 2Greece
43NCT03976648
(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 SclerosisSclerosis, SystemicDrug: GLPG1690Galapagos NVNULLActive, not recruiting18 YearsN/AAll31Phase 2United States;Belgium;Italy;Spain;United Kingdom
44EUCTR2015-004613-24-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
45EUCTR2018-003149-41-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03919799
(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, LLCNULLRecruiting18 Years100 YearsAll60Phase 2United States
47EUCTR2018-004655-20-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
48EUCTR2018-003149-41-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]
CSL Behring GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
26Phase 2France;Poland;Australia;Germany;Italy;United Kingdom
49NCT03957681
(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
50JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2018-003149-41-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
52EUCTR2018-001817-33-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
53NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll264Phase 1United States
54EUCTR2018-001817-33-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;Belgium;Spain;Germany;Italy;United Kingdom
55NCT03867097
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-001817-33-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
57NCT03798366
(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 SclerosisSclerodermaDrug: GLPG1690;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll33Phase 2United States;Belgium;Germany;Italy;Spain;United Kingdom
58JPRN-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
59NCT03831438
(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
60NCT03817424
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2018-001719-65-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]University Medial Center GroningenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 4Netherlands
62NCT03742466
(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
63NCT03675581
(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
64NCT03717961
(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
65EUCTR2016-003403-66-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 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2017-000372-29-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
67EUCTR2016-003403-66-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
68NCT03575156
(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
69EUCTR2016-003417-95-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
70NCT03678987
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03629002
(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
72NCT03558854
(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 PauloNULLRecruiting18 Years65 YearsAll70Phase 4Brazil
73NCT03630211
(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
74EUCTR2016-003403-66-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
75EUCTR2017-000372-29-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;Italy;Switzerland;United Kingdom;France;Canada;Poland;Australia;Netherlands;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2016-003403-66-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
77NCT03365869
(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
78NCT03593902
(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
79NCT03508375
(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
80NCT03607071
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2017-000372-29-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
354Phase 3United States;Spain;Israel;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
82EUCTR2016-003403-66-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 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
83EUCTR2016-003403-66-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
84EUCTR2016-003403-66-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
85EUCTR2016-003403-66-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2017-000372-29-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]
Corbus pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
354Phase 3United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
87EUCTR2017-000372-29-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]
Corbus pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
354Phase 3United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Japan;Korea, Republic of
88EUCTR2016-003403-66-PT
(EUCTR)
23/02/201813/12/2017 A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (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]
Unilfarma - União Internacional de Lab. Farmacêuticos, Lda.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400Phase 3United 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
89EUCTR2016-003403-66-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
90NCT03430388
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2016-003403-66-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
92NCT03444220
(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
93NCT03398837
(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.NULLActive, not recruiting18 YearsN/AAll365Phase 3United States;Australia;Canada;Germany;Israel;Japan;Korea, Republic of;Netherlands;Poland;Spain;Switzerland;United Kingdom
94NCT03313180
(ClinicalTrials.gov)
November 27, 201713/10/2017A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis.An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)Lung Diseases, InterstitialDrug: NintedanibBoehringer 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
95JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2016-003403-66-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
97JPRN-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
98NCT04368403
(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
99EUCTR2015-001617-27-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]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
100EUCTR2016-002651-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2015-000392-28-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
102EUCTR2015-000392-28-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]
Boehringer Ingelheim RCV GmbH & Co KGNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
103NCT03041025
(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
104EUCTR2015-000392-28-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 KSNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
105NCT03155464
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2015-001617-27-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]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
107EUCTR2015-000392-28-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
108EUCTR2015-000392-28-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
109NCT03068234
(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
110EUCTR2015-000392-28-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]
Boehringer Ingelheim Finland KyNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2016-002984-32-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
112EUCTR2015-002586-39-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
113EUCTR2016-003417-95-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
114NCT02682511
(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
115NCT03059979
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT02866552
(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
117EUCTR2016-001028-80-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
118JPRN-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
119NCT03007004
(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
120NCT03053739
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02921971
(ClinicalTrials.gov)
November 23, 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 (ACT14604);Drug: PlaceboSanofiNULLCompleted18 YearsN/AAll97Phase 2United States;Argentina;Belgium;Estonia;France;Germany;Italy;Mexico;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Austria
122EUCTR2016-001028-80-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
123EUCTR2015-002586-39-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
124EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
125EUCTR2016-001028-80-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]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2015-002586-39-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
127NCT02896205
(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
128EUCTR2016-001028-80-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]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94Phase 2United States;Estonia;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
129NCT02798055
(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
130EUCTR2016-001028-80-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]
sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Argentina;Belgium;Poland;Romania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2015-002586-39-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]
medac GmbHNULLNot Recruiting Female: yes
Male: yes
148Phase 3Portugal;France;United States;Hungary;Poland;Belgium;Romania;Netherlands;Germany;Italy;United Kingdom;Switzerland
132EUCTR2015-002586-39-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
133EUCTR2015-005023-11-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
134EUCTR2015-002586-39-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
135EUCTR2015-002586-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2015-000168-32-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
137EUCTR2015-005023-11-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
138EUCTR2015-005023-11-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
139EUCTR2015-005023-11-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
140JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2015-000392-28-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
142EUCTR2015-001617-27-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
143NCT02733978
(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
144EUCTR2015-004613-24-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
145EUCTR2014-002796-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2015-000392-28-PL
(EUCTR)
09/03/201621/01/2016A 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: 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 KGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden
147NCT02680717
(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
148NCT02588625
(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
149EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United 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
150EUCTR2015-000392-28-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]
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot Recruiting Female: yes
Male: yes
750Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT02530996
(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;Other: Vasculopathy assessment;Drug: PlaceboVA Office of Research and DevelopmentNULLCompleted18 Years95 YearsAll32United States
152EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United 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
153EUCTR2015-000424-28-HR
(EUCTR)
18/12/201501/02/2016A 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: 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3Portugal;United States;Greece;Spain;Lithuania;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Japan
154EUCTR2015-000392-28-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
155EUCTR2015-000392-28-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. VNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT02453256
(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
157EUCTR2015-000392-28-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
158EUCTR2015-000392-28-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
159NCT02597933
(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
160EUCTR2015-000392-28-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]
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2015-000392-28-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]
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
162EUCTR2015-000424-28-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
163EUCTR2015-000392-28-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
164NCT02503644
(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
165EUCTR2015-001617-27-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]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
167JPRN-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
168EUCTR2015-000392-28-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]
Boehringer-Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
169EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United 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
170EUCTR2015-001617-27-IT
(EUCTR)
18/09/201517/06/2015A 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 . 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 SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Switzerland;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2015-001617-27-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]
Inventiva SANULLNot Recruiting Female: yes
Male: yes
170Phase 2Slovenia;Spain;Bulgaria;Netherlands;Germany;Italy;Switzerland;United Kingdom
172EUCTR2014-005323-27-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]
University of MichiganNULLNot Recruiting Female: yes
Male: yes
86Phase 2United States;Canada;Italy;United Kingdom
173EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United 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
174EUCTR2015-001617-27-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
175EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT02558543
(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
177EUCTR2015-000424-28-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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
210Phase 3United 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
178NCT02465437
(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
179EUCTR2015-000424-28-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
180JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT02371005
(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, FranceNULLRecruiting18 YearsN/AAll90N/AFrance
182NCT02349009
(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
183NCT03692299
(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
184NCT02386436
(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
185EUCTR2014-001353-16-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT02411643
(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
187EUCTR2014-001101-40-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]
University College London (UCL)NULLNot Recruiting Female: yes
Male: yes
26Phase 2United Kingdom
188EUCTR2014-001353-16-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
189EUCTR2014-001353-16-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]
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
190EUCTR2014-001353-16-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]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130Phase 2United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT02283762
(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
192NCT02642146
(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
193EUCTR2014-001353-16-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]
Bayer AGNULLNot Recruiting Female: yes
Male: yes
130Phase 2United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
194EUCTR2014-001353-16-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]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan
195EUCTR2014-001353-16-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2014-001353-16-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]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
130Phase 2United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan
197NCT02363478
(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
198JPRN-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
199NCT02374320
(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
200NCT02228850
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2014-000865-34-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
202EUCTR2014-001882-28-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
203NCT02260557
(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
204EUCTR2014-000865-34-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
205NCT02166229
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT02213705
(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
207NCT02212249
(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
208EUCTR2013-003200-39-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]
University College LondonNULLNot Recruiting Female: yes
Male: yes
72Phase 2United Kingdom
209JPRN-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
210EUCTR2013-004596-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2010-022710-77-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
295Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
212JPRN-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
213EUCTR2012-003633-42-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
214EUCTR2013-001353-28-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
215NCT01933334
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2012-004955-35-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
217JPRN-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
218NCT01878526
(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
219NCT03561233
(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
220NCT01804959
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT01748084
(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
222NCT02002897
(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
223EUCTR2012-005348-92-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
224EUCTR2012-001369-34-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
225NCT01651143
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2012-001369-34-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
227EUCTR2012-001369-34-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]
Sanofi-aventis recherche & développementNULLNot Recruiting Female: yes
Male: yes
30Phase 2United States;Canada;Germany;Italy;Switzerland;United Kingdom
228NCT01895244
(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
229NCT02169752
(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
230NCT01559129
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2010-023047-15-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
232EUCTR2010-022710-77-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
233EUCTR2010-022969-95-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
234JPRN-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
235EUCTR2010-022710-77-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2010-022969-95-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
237EUCTR2011-002434-40-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
238EUCTR2010-023047-15-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
239EUCTR2010-023047-15-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
240EUCTR2010-023047-15-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]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
88Phase 2France;United States;Poland;Spain;Australia;Russian Federation;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2011-005303-32-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
242EUCTR2010-023047-15-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
243NCT01532869
(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
244NCT01553981
(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
245EUCTR2010-022969-95-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2010-022969-95-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;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
247NCT01497743
(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
248NCT01554540
(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
249EUCTR2011-001460-22-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]
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
86Phase 2;Phase 3France;United States;Canada;Germany;United Kingdom
250EUCTR2010-022969-95-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2010-022710-77-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
252EUCTR2010-022969-95-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
253EUCTR2010-022969-95-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
254NCT01487551
(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
255NCT01474122
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT01474109
(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
257EUCTR2011-001460-22-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;Phase 3France;United States;Canada;Germany;United Kingdom
258EUCTR2010-022710-77-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
259NCT02240888
(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
260EUCTR2011-001667-44-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261NCT01445821
(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
262EUCTR2010-022969-95-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
263EUCTR2011-001667-44-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
264EUCTR2010-022710-77-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
265EUCTR2010-022969-95-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT01639573
(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;Phase 2United States
267EUCTR2010-022710-77-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
268EUCTR2010-024005-13-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
269NCT01395732
(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
270NCT01315899
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2010-022710-77-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
272NCT01284322
(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
273EUCTR2010-019977-14-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
274EUCTR2009-018194-31-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
275NCT01295736
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2009-013468-37-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
Royal National Hospital for Rheumatic DiseaseNULLNot Recruiting Female: yes
Male: yes
70Phase 2United Kingdom
277EUCTR2009-017869-27-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
278EUCTR2010-021452-26-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
279JPRN-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
280JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT02339441
(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
282EUCTR2008-001265-28-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
283NCT00946699
(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
284NCT01374282
(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
285NCT01586663
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT01002508
(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
287NCT00930683
(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
288NCT00848107
(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
289NCT00962923
(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
290EUCTR2007-002015-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291NCT00936546
(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, GhentNULLActive, not recruiting18 YearsN/ABoth10Phase 2Belgium
292EUCTR2008-007180-16-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
293NCT00775463
(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
294EUCTR2007-003621-24-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
295EUCTR2008-005018-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2008-006978-15-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
297NCT00764309
(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
298EUCTR2007-004669-17-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
299EUCTR2007-003621-24-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
MondoGEN AGNULLNot Recruiting Female: yes
Male: yes
48Phase 2France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
300NCT00848939
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT00769028
(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
302EUCTR2008-001265-28-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
303EUCTR2006-004598-83-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
304EUCTR2008-000224-27-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
305EUCTR2008-001265-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2008-001265-28-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
307NCT00984932
(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
308EUCTR2007-003621-24-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
309EUCTR2007-003621-24-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
310EUCTR2007-004669-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311EUCTR2007-003621-24-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
312EUCTR2008-001265-28-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
313NCT00725361
(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
314EUCTR2007-003621-24-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
315EUCTR2007-003122-24-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
Daval International LimitedNULLNot Recruiting Female: yes
Male: yes
20Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2007-003621-24-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
317EUCTR2007-004669-17-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
318NCT00613171
(ClinicalTrials.gov)
January 200825/1/2008Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic SclerosisA Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic SclerosisSystemic Sclerosis, SclerodermaDrug: STI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll27Phase 2United States;Germany;Italy;Switzerland;United Kingdom
319EUCTR2007-002015-38-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
320EUCTR2007-002015-38-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
ISDINNULLNot Recruiting Female: yes
Male: yes
98Phase 2Hungary;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321NCT00581997
(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
322NCT00626665
(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
323NCT00577304
(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
324EUCTR2007-006035-32-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
325EUCTR2007-005322-68-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326EUCTR2007-001508-19-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
327EUCTR2007-002015-38-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
328EUCTR2006-007091-15-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
329EUCTR2007-002015-38-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
330NCT00684255
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT00506831
(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
332NCT00498615
(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
333NCT00463125
(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
334JPRN-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;Phase 2Japan
335NCT00428883
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT00419419
(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
337EUCTR2005-004979-37-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 sclerodermaMediQuest Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
100Phase 3United Kingdom;Sweden
338NCT00379431
(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
339EUCTR2005-004979-37-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
340EUCTR2006-002081-19-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2006-003957-25-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
342EUCTR2006-003836-31-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
343EUCTR2006-005230-20-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
344NCT00348296
(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
345NCT00378521
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346EUCTR2006-000905-41-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
347NCT00318175
(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
348EUCTR2005-000701-61-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 crisisUniversity College LondonNULLNot Recruiting Female: yes
Male: yes
15Phase 2United Kingdom
349NCT00278525
(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
350NCT00147771
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT00114530
(ClinicalTrials.gov)
June 200515/6/2005Scleroderma: Cyclophosphamide or Transplantation (SCOT)A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)Scleroderma, Systemic;Sclerosis;Autoimmune DiseaseBiological: mHSCT;Drug: cyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll75Phase 2;Phase 3United States;Canada
352NCT00860548
(ClinicalTrials.gov)
June 200511/3/2009SCOT Scleroderma Treatment Alternative Registry (STAR Registry)An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02)Scleroderma, Systemic;SclerosisDrug: currently available therapy in the communityNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll19N/AUnited States
353NCT00282425
(ClinicalTrials.gov)
May 200524/1/2006Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisNon-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic SclerosisSclerodermaBiological: Hematopoietic stem cell transplantationRichard Burt, MDNULLTerminated18 Years55 YearsBoth8Phase 1United States
354EUCTR2004-000632-82-IT
(EUCTR)
06/04/200515/03/2007Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcersLong term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers Healing and prevention of ischemic digital ulcers in patients with systemic sclerosis
Level: PTClassification code 10059084
Trade Name: TRACLEER*56CPR RIV 125MG
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
180Italy
355JPRN-UMIN000020701
2005/03/1022/01/2016The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic sclerodermaThe efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma - The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma reflux esophagitis associated with systemic sclerodermaRabeprazole sodium 1 tablet a day will be added to subjects whose symptom does not improve with 1 tablet a day. The study will continue until subjects meet discontinuance criteria.Faculty of Medicine,Institute of Medical, Pharmaceutical and Health Sciences,Kanazawa UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female40Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356EUCTR2004-002712-28-IT
(EUCTR)
28/02/200515/02/2006Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study.Chronic iloprost administration in scleroderma patients effect on disease progression, as assessed by skin fibrosis evaluation. A randomized, controlled, blind-observer, multicenter phase III study. Disease progression in scleroderma.
MedDRA version: 6.1;Level: HLT;Classification code 10039711
Trade Name: ENDOPROST 0,05MG/0,5ML 1F
INN or Proposed INN: iloprost trometamol
ITALFARMACONULLNot RecruitingFemale: yes
Male: yes
69Phase 3Italy
357NCT00226889
(ClinicalTrials.gov)
January 200523/9/2005Treatment of Early Systemic Sclerosis by BosentanSystemic Sclerosis (Scleroderma)Drug: bosentanRikshospitalet University HospitalNULLTerminated18 Years70 YearsBoth30Phase 1;Phase 2Norway
358NCT00253331
(ClinicalTrials.gov)
November 200413/11/2005Lab Study of MQX-503 in Treatment of Raynaud'sPhase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s PhenomenonRaynaud Disease;Raynaud Disease Secondary to Scleroderma;Raynaud Secondary to Other Autoimmune DiseaseDrug: topical organogel with nitroglycerinMediQuest TherapeuticsNULLCompleted18 Years80 YearsBoth36Phase 2;Phase 3United States
359EUCTR2004-000632-82-GB
(EUCTR)
16/09/200411/02/2005Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extensionLong term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the diseaseTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Italy;United Kingdom
360EUCTR2004-000631-28-IT
(EUCTR)
14/09/200417/09/2004Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2.Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. Interstitial lung disease associated with systemic sclerosisTrade Name: TRACLEER*125MG 56CPR RIV.
Product Name: NA
Product Code: NA
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361NCT00319696
(ClinicalTrials.gov)
July 8, 200427/4/2006Bosentan in Digital UlcersLong-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital UlcersDigital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mgActelionNULLCompleted18 YearsN/AAll116Phase 3United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom
362NCT00319033
(ClinicalTrials.gov)
July 200426/4/2006Open-label Study With Bosentan in Interstitial Lung DiseaseLong-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.Interstitial Lung Disease;SclerodermaDrug: bosentanActelionNULLCompleted18 YearsN/ABoth132Phase 2;Phase 3United States;Canada;France;Germany;Israel;Italy;Korea, Republic of;Netherlands;Sweden;Switzerland;United Kingdom
363NCT00740285
(ClinicalTrials.gov)
April 200419/8/2008Effectiveness and Safety of Lidocaine for SclerodermaEffectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical TrialSclerodermaDrug: Lidocaine 2% without vessel constrictor;Other: Placebo - physiological solution 0,9%Federal University of São PauloNULLCompleted18 Years60 YearsBoth26Phase 2;Phase 3Brazil
364NCT00624273
(ClinicalTrials.gov)
February 200414/2/2008Sildenafil for Treatment of Digital Ulcers in Patients With Systemic SclerosisEffect of Sildenafil on Digital Ulcers in Systemic SclerosisActive Digital UlcersDrug: Sildenafil therapyCharite University, Berlin, GermanyNULLCompleted18 Years80 YearsBoth17Phase 2Germany
365NCT00077584
(ClinicalTrials.gov)
October 200310/2/2004Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisDigital Ulcers;Systemic SclerosisDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth188Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366NCT02800993
(ClinicalTrials.gov)
October 200313/6/2016Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With SclerodermaA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic SclerosisSystemic Sclerosis;Digital UlcersDrug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: PlaceboActelionNULLCompleted18 YearsN/ABoth188Phase 3United States;Canada
367NCT00070590
(ClinicalTrials.gov)
July 20036/10/2003Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With SclerodermaA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic SclerosisPulmonary Fibrosis;Scleroderma, SystemicDrug: BosentanActelionNULLCompleted18 YearsN/ABoth132Phase 2;Phase 3United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom
368NCT00241189
(ClinicalTrials.gov)
August 200214/10/2005Rapamycin vs Methotrexate in Diffuse SScA 48-week, Double-blind, Randomized, Parallel Phase I/II Study of Oral Rapamycin Versus Methotrexate in Systemic Sclerosis (Scleroderma)Systemic SclerosisDrug: rapamycin;Drug: methotrexateUniversity of California, Los AngelesNULLCompleted18 Years70 YearsBoth17Phase 1;Phase 2United States
369NCT00707187
(ClinicalTrials.gov)
July 200125/6/2008Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual DysfunctionRandomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic SclerosisSystemic SclerosisDrug: CialisUniversity of Medicine and Dentistry of New JerseyNULLCompleted18 YearsN/AFemale120Phase 2United States
370NCT00025818
(ClinicalTrials.gov)
May 200126/10/2001Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromeKeratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, SystemicDrug: Ophthalmic EmulsionAllerganNULLCompleted18 YearsN/ABoth290Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT00501995
(ClinicalTrials.gov)
February 200113/7/2007High Dose Cyclophosphamide for Treatment of SclerodermaHigh Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma)SclerodermaDrug: IV CyclophosphamideJohns Hopkins UniversityNULLCompleted18 Years70 YearsAll6Phase 3United States
372NCT00016458
(ClinicalTrials.gov)
June 20006/5/2001Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic SclerosisSystemic SclerosisDrug: anti-thymocyte globulin;Drug: cyclophosphamideFred Hutchinson Cancer Research CenterNULLCompletedN/A64 YearsBoth20Phase 2United States
373NCT00004563
(ClinicalTrials.gov)
August 19999/2/2000Scleroderma Lung DiseaseCyclophosphamide Versus Placebo in Scleroderma Lung StudyLung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, SystemicDrug: Cyclophosphamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll158Phase 3NULL
374NCT00704665
(ClinicalTrials.gov)
December 199823/6/2008Recombinant Human Relaxin in the Treatment of Diffuse SclerodermaA Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human Relaxin in the Treatment of Systemic Sclerosis With Diffuse SclerodermaSystemic SclerosisDrug: RelaxinUniversity of Medicine and Dentistry of New JerseyUniversity of California, Los Angeles;Boston University;University of Chicago;University of Connecticut Health Center;Johns Hopkins University;University of Pittsburgh;Medical University of South Carolina;Stanford University;Georgetown University;University of California, San Diego;Wayne State University;University of Colorado, Denver;Medical College of WisconsinCompleted18 Years70 YearsBoth231Phase 3NULL
375NCT00004786
(ClinicalTrials.gov)
December 199524/2/2000Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic SclerosisSystemic Sclerosis;Raynaud DiseaseDrug: iloprostNational Center for Research Resources (NCRR)University of PittsburghCompleted18 YearsN/ABoth200Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT00004380
(ClinicalTrials.gov)
December 199118/10/1999Phase II Study of Recombinant Relaxin for Progressive Systemic SclerosisSystemic SclerosisDrug: relaxinNational Center for Research Resources (NCRR)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Stanford UniversityCompletedN/AN/ABoth1Phase 2NULL