| 1 |
NCT03198689 |
Not yet recruiting |
Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Brentuximab Vedotin
|
Interventional |
Phase 2 |
- Lawson Health Research Institute
- Seattle Genetics, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in skin thickness measured by modified Rodnan Skin Score (mRSS)
- Change in mRSS
- CRISS score >20%
- (and 5 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03198689 |
BV201708 |
|
September 1, 2018 |
November 1, 2018 |
June 1, 2019 |
June 26, 2017 |
March 7, 2018 |
|
- Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada
|
| 2 |
NCT03398837 |
Recruiting |
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Lenabasum 5 mg
- Drug: Lenabasum 20 mg
- Other: Placebo oral capsule
|
Interventional |
Phase 3 |
- Corbus Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.
- Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.
- Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.
- Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.
|
354 |
All |
18 Years and older (Adult, Senior) |
NCT03398837 |
JBT101-SSc-002 |
RESOLVE-1 |
December 18, 2017 |
March 2020 |
March 2020 |
January 16, 2018 |
April 19, 2018 |
|
- Pacific Arthritis Care Center
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - John Hopkins University, Scleroderma Center
Baltimore, Maryland, United States - (and 4 more...)
|
| 3 |
NCT02339441 |
Completed |
Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis |
- Early Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Methotrexate
- Drug: Mycophenolate mofetil
- Drug: Cyclophosphamide
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Skin score as measured by modified rodnan skin score
- Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP)
- Echocardiographic findings
- (and 7 more...)
|
320 |
All |
18 Years and older (Adult, Senior) |
NCT02339441 |
10H101429 |
ESOS |
June 2010 |
December 2015 |
March 2016 |
January 15, 2015 |
May 13, 2016 |
|
|
| 4 |
NCT02161406 |
Active, not recruiting |
A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Abatacept
- Drug: Placebo
|
Interventional |
Phase 2 |
- Dinesh Khanna, MD, MS
- Bristol-Myers Squibb
- National Institute of Allergy and Infectious Diseases (NIAID)
- University of Michigan
|
Other / Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs) and Serious AEs (SAEs)
- Change from baseline in the modified Rodnan skin score (mRSS) to month 12
- Positive or negative change on 28- tender/swollen joint counts
- (and 2 more...)
|
86 |
All |
18 Years and older (Adult, Senior) |
NCT02161406 |
IM101-344
1UM1AI110557 |
ASSET |
September 2014 |
September 28, 2018 |
September 28, 2018 |
June 11, 2014 |
March 8, 2018 |
|
- Arthritis Associates of Southern California
Los Angeles, California, United States - University of California- Los Angeles
Los Angeles, California, United States - Stanford University
Redwood City, California, United States - (and 24 more...)
|
| 5 |
NCT02503644 |
Active, not recruiting |
Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis |
- Scleroderma, Diffuse
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: IVA337
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Measurement of skin thickness by the Modified Rodnan Skin Score (MRSS)
- Response rates based on MRSS improvement
- Overall progression of the disease: defined as absence of rescue therapy and absence of severe organ involvement
- (and 15 more...)
|
132 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02503644 |
IVA_01_337_HSSC_15_001 |
FASST |
October 2015 |
October 2017 |
November 2018 |
July 21, 2015 |
November 24, 2017 |
|
- Hôpital Pellegrin
Bordeaux, France - CHRU de Lille- Hôpital Claude Huriez
Lille, France - Hôpital Lapeyronie CHRU Montpellier
Montpellier, France - (and 40 more...)
|
| 6 |
NCT01586663 |
Unknown † |
Serial Night Time Position Splint on Systemic Sclerosis |
- Diffuse Systemic Sclerosis
|
- Device: Serial night time position splint
- Drug: Drug treatment
|
Interventional |
Phase 3 |
- Federal University of São Paulo
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in hand range of motion
- Change in pain
- Change in functional capacity
- (and 3 more...)
|
76 |
All |
18 Years and older (Adult, Senior) |
NCT01586663 |
CEP 1070/09 |
|
January 2010 |
December 2012 |
December 2012 |
April 27, 2012 |
May 1, 2012 |
|
- Universidade Federal de Sao Paulo
Sao Paulo, SP, Brazil
|
| 7 |
NCT01284322 |
Completed |
Fresolimumab In Systemic Sclerosis |
- Diffuse Systemic Sclerosis
|
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate safety of fresolimumab in patients with scleroderma
- To investigate the effect of fresolimumab on TGF-beta responsive gene expression in skin after treatment with fresolimumab compared to pre-treatment TGF-beta responsive gene expression.
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01284322 |
H30142 |
|
January 2011 |
June 2013 |
March 2014 |
January 27, 2011 |
July 16, 2014 |
|
- Boston University School of Medicine; Rheumatology/Arthritis Center
Boston, Massachusetts, United States
|
| 8 |
NCT02465437 |
Active, not recruiting |
Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: JBT-101
- Drug: Placebo
- Drug: Part B Open-Label Extension
|
Interventional |
Phase 2 |
- Corbus Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of participants with treatment-emergent adverse events from baseline at Day 113
- Change in Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) from baseline at Day 85
- Number of participants with treatment-emergent adverse events from baseline at Day 394
- (and 6 more...)
|
42 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02465437 |
JBT101-SSc-001 |
|
August 2015 |
December 2017 |
October 2018 |
June 8, 2015 |
October 23, 2017 |
|
- Arthritis Association of Southern CA
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - John Hopkins Scleroderma Center
Baltimore, Maryland, United States - (and 6 more...)
|
| 9 |
NCT02370784 |
Recruiting |
Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma |
|
- Drug: atorvastatin
- Drug: Placebo
|
Interventional |
Phase 2 |
- Robyn T. Domsic, MD, MPH
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- University of Pittsburgh
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- effect of atorvastatin therapy on change in microvascular endothelial function by Noninvasive vascular testing.
- effect of atorvastatin on change in Raynaud symptoms measured by a patient reported questionnaire.
- effect of atorvastatin on change in microcirculatory flow by Noninvasive vascular testing.
- effect of atorvastatin on change in macrovascular endothelial function by using Noninvasive vascular testing.
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02370784 |
PRO14010170
1R21AR066305-01A1 |
TAMER |
February 2015 |
February 2019 |
December 2019 |
February 25, 2015 |
March 15, 2018 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
| 10 |
NCT01093885 |
Completed |
Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis |
- Systemic Sclerosis
- Scleroderma
|
|
Interventional |
Not Applicable |
- University of Pennsylvania
- Gilead Sciences
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary objective of this study is to determine the benefit that an antifibrotic agent and ambrisentan combination have on the cutaneous involvement of patients with early diffuse systemic sclerosis by utilizing the MRSS.
- Secondary objectives will examine systemic sclerosis as it relates to visceral organ involvement based on the Medsger severity scale as well as quality of life as assessed by the Scleroderma health assessment questionnaire (SHAQ) and SF-36.
|
15 |
All |
19 Years to 90 Years (Adult, Senior) |
NCT01093885 |
Ambrj55501. |
|
February 2010 |
July 2016 |
July 2016 |
March 26, 2010 |
May 2, 2017 |
|
- University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
|
| 11 |
NCT00428883 |
Unknown † |
High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis |
|
- Drug: N-acetylcysteine (NAC)
|
Interventional |
Phase 2
Phase 3 |
- Università Politecnica delle Marche
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- The primary outcome is the reduction of skin thickness
- Evaluated by the modified Rodnan skin score.
- scleroderma disease activity assessed as established
- (and 3 more...)
|
45 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00428883 |
FARM5X8AWM |
|
January 2007 |
|
February 2009 |
January 30, 2007 |
January 30, 2007 |
|
- Università politecnica delle marche
Ancona, Italy - Università de L’Aquila
Aquila, Italy - Università di Firenze
Firenze, Italy - (and 2 more...)
|
| 12 |
NCT00043706 |
Completed |
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis |
- Systemic Sclerosis
- Scleroderma
|
- Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
|
Interventional |
Phase 1
Phase 2 |
- Genzyme, a Sanofi Company
- Cambridge Antibody Technology
- Sanofi
|
Industry / Other |
- Primary Purpose: Treatment
|
|
|
All |
18 Years to 75 Years (Adult, Senior) |
NCT00043706 |
ATGFB1-001-01 |
|
|
|
September 2003 |
August 14, 2002 |
March 5, 2015 |
|
- UCLA—Department of Medicine, Division of Rheumatology
Los Angeles, California, United States - Boston Medical Center
Boston, Massachusetts, United States - UMDNJ Scleroderma Program
New Brunswick, New Jersey, United States - University of Texas - Houston Medical School
Houston, Texas, United States
|
| 13 |
NCT01670565 |
Completed |
Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis |
|
|
Interventional |
Phase 2 |
- Hospital for Special Surgery, New York
- Human Genome Sciences Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Modified Rodnan Skin Score
- Number of Participants with Adverse and Serious Adverse Events
- Change in Pulmonary Function Test Measures
- (and 2 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01670565 |
12006 |
|
August 2012 |
November 2015 |
February 2016 |
August 22, 2012 |
March 16, 2017 |
|
- Hospital for Special Surgery
New York, New York, United States
|
| 14 |
NCT02921971 |
Recruiting |
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis |
|
- Drug: SAR156597 (ACT14604)
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in mRSS
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), assessed with SHAQ
- Change from baseline in respiratory function as measured by observed Forced Vital Capacity (FVC)
- Change from baseline in observed Carbon Monoxide Diffusing Lung Capacity (DLco [corrected for hemoglobin])
|
94 |
All |
18 Years and older (Adult, Senior) |
NCT02921971 |
ACT14604
2016-001028-80
U1111-1179-4690 |
|
November 2016 |
October 2018 |
April 2, 2019 |
October 3, 2016 |
April 12, 2018 |
|
- Investigational Site Number 8400006
San Francisco, California, United States - Investigational Site Number 8400005
Washington, District of Columbia, United States - Investigational Site Number 8400003
Baltimore, Maryland, United States - (and 48 more...)
|
| 15 |
NCT00704665 |
Completed |
Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma |
|
|
Interventional |
Phase 3 |
- University of Medicine and Dentistry of New Jersey
- University of California, Los Angeles
- Boston University
- (and 12 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
231 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00704665 |
2773 |
|
December 1998 |
December 2001 |
December 2001 |
June 25, 2008 |
June 25, 2008 |
|
|
| 16 |
NCT03222492 |
Recruiting |
Brentuximab Vedotin for Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
- Scleroderma
- dcSSc
|
- Biological: Brentuximab Vedotin
- Biological: Placebo
|
Interventional |
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Immune Tolerance Network (ITN)
- Seattle Genetics, Inc.
|
NIH / Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of participants who experience at least one Grade 3 or higher adverse event
- Proportion of participants who experience at least one Grade 2 or higher adverse event
- Proportion of participants with Grade 2 or higher peripheral neuropathy
- (and 3 more...)
|
24 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03222492 |
DAIT ITN075AI
ITN075AI |
BRAVOS |
September 20, 2017 |
September 2020 |
September 2020 |
July 19, 2017 |
March 8, 2018 |
|
- UCLA Medical Center: Division of Rheumatology
Los Angeles, California, United States - Georgetown University Medical Center: Division of Rheumatology
Washington, District of Columbia, United States - Boston University School of Medicine: Rheumatology Section, Scleroderma Clinical Centers
Boston, Massachusetts, United States - (and 6 more...)
|
| 17 |
NCT00433186 |
Completed |
Mycophenolate Mofetil in Systemic Sclerosis |
- Diffuse Cutaneous Systemic Sclerosis
|
- Drug: Mycophenolate Mofetil
|
Interventional |
Phase 1 |
- Boston University
- Aspreva Pharmaceuticals
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Skin Study: The primary evaluation of response will be improvement of the modified Rodnan skin score @ 6 months. Improvement of skin score, correlates with improvement in joint function, functional status and physician's global assessment.
- Muscle Sub Study:The primary evaluation of response will be the CK at 6 months compared to baseline.Improvement after 6 months of tx compared to baseline CK will suggest efficacy
- Safety evaluation.
- Secondary evaluations of response. Scleroderma Health Assessment Questionnaire (SHAQ): The SHAQ will be evaluated at study entry compared to 6 and 12 months.
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00433186 |
H-25973 |
|
March 2006 |
March 2011 |
March 2011 |
February 9, 2007 |
March 31, 2011 |
|
- Boston University School of Medicine
Boston, Massachusetts, United States
|
| 18 |
NCT00769028 |
Unknown † |
AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis |
|
- Drug: Hyperimmune caprine serum
- Drug: Albumin
|
Interventional |
Phase 2 |
- Daval International Limited
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Modified Rodnan Skin Score
- Scleroderma Health Assessment Questionnaire
- Scleroderma UK Functional Score
- (and 3 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT00769028 |
DISS01 |
|
December 2008 |
February 2011 |
September 2011 |
October 8, 2008 |
August 18, 2011 |
|
- Centre for Rheumatology and Connective Tissue Diseases, Lower Ground Floor, Royal Free Hospital NHS Trust, Hampstead
London, United Kingdom
|
| 19 |
NCT01785056 |
Completed |
IVIG Treatment in Systemic Sclerosis |
- Systemic Sclerosis
- Diffuse Scleroderma
|
|
Interventional |
Not Applicable |
- Georgetown University
- CSL Behring
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- To study the effects of IVIG on the skin in patients with scleroderma
- To determine any toxicity of IVIG in scleroderma
- To evaluate the effects of IVIG on pulmonary function
- Muscle, joint, and inflammatory parameters
|
14 |
All |
18 Years and older (Adult, Senior) |
NCT01785056 |
Pro00000052 |
|
April 2013 |
December 2016 |
January 2018 |
February 6, 2013 |
March 12, 2018 |
|
- Georgetown University Hospital
Washington, District of Columbia, United States - Johns Hopkins Hospital
Baltimore, Maryland, United States
|
| 20 |
NCT03274076 |
Recruiting |
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) |
- Systemic Sclerosis
- Scleroderma
|
- Drug: Tofacitinib
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 1
Phase 2 |
- University of Michigan
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs) and Serious AE (SAEs)
- Number of Grade 3(severe) or higher adverse events that occur throughout the study
- Number of Grade 2 (moderate) or higher adverse events that occur throughout the study
- (and 3 more...)
|
15 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03274076 |
HUM000131837 |
TOFA-SSc |
October 2, 2017 |
December 2018 |
April 2020 |
September 6, 2017 |
October 10, 2017 |
|
- University of Michigan
Ann Arbor, Michigan, United States - University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
| 21 |
NCT01545427 |
Terminated |
Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma |
|
- Drug: Imatinib mesylate
- Other: Placebo
|
Interventional |
Phase 2 |
- Lawson Health Research Institute
- Novartis Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in the levels of fibrotic and inflammatory biomarkers in plasma samples.
- Changes in the levels of fibrotic and inflammatory biomarkers in skin biopsies.
- Modified Rodnan Skin Score (MRSS)
- (and 6 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01545427 |
R-07-214
#031-06 |
|
April 2008 |
December 2008 |
December 2008 |
March 6, 2012 |
March 7, 2012 |
|
- Lawson Health Research Institute
London, Ontario, Canada
|
| 22 |
NCT02264405 |
Unknown † |
Autologous SCT for Progressive Systemic Sclerosis: a Prospective NIS Study |
|
- Procedure: Autologous HSCT
|
Observational |
|
- European Group for Blood and Marrow Transplantation
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Progression free survival
- Safety
- Overall Survival
- (and 4 more...)
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02264405 |
EBMT-8410015 |
NISSC |
December 2012 |
December 2015 |
December 2017 |
October 15, 2014 |
October 20, 2014 |
|
- Badoglio Manuela- EBMT Paris Office
Paris, France
|
| 23 |
NCT01895244 |
Recruiting |
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis |
- Scleroderma
- Cardiac Involvement
- Autologous Stem Cell Transplantation
|
- Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells
|
Interventional |
Phase 2 |
- University Hospital Tuebingen
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Treatment related mortality
- Time to engraftment
- (and 2 more...)
|
44 |
All |
18 Years to 65 Years (Adult) |
NCT01895244 |
AST MOMA |
AST-MOMA |
September 2012 |
September 2018 |
September 2020 |
July 10, 2013 |
October 25, 2016 |
|
- University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology
Tuebingen, Germany
|
| 24 |
NCT03041025 |
Recruiting |
Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis |
|
- Drug: GSK2330811
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of participants with any adverse event (AE) and any serious adverse event (SAE) as a measure of safety and tolerability
- Hematology assessed as a measure of safety and tolerability
- Clinical chemistry assessed as a measure of safety and tolerability
- (and 12 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03041025 |
201247 |
|
June 5, 2017 |
July 15, 2019 |
July 15, 2019 |
February 2, 2017 |
March 29, 2018 |
|
- GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Baltimore, Maryland, United States - GSK Investigational Site
Boston, Massachusetts, United States - (and 7 more...)
|
| 25 |
NCT02682511 |
Recruiting |
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension |
- Scleroderma, Diffuse
- Scleroderma, Systemic
- Scleroderma, Limited
- (and 5 more...)
|
- Drug: Oral Ifetroban
- Drug: Oral Placebo
|
Interventional |
Phase 2 |
- Cumberland Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs) and Serious AEs (SAEs)
- Change from baseline in forced vital capacity (FVC)
- Change from baseline in diffusion capacity for carbon monoxide (DLCO)
- Change from baseline in the modified Rodnan skin score (mRSS)
|
34 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02682511 |
CPI-IFE-004 |
|
January 2017 |
December 2018 |
December 2019 |
February 15, 2016 |
January 5, 2018 |
|
- UCLA
Los Angeles, California, United States - Johns Hopkins University
Baltimore, Maryland, United States - Massachusetts General Hospital
Boston, Massachusetts, United States - (and 3 more...)
|
| 26 |
NCT02588625 |
Withdrawn |
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc) |
|
- Drug: BMS-986020
- Other: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Part A - Change in modified Rodnan skin score (mRSS)
- Part B - Change in modified Rodnan skin score (mRSS)
- Part A: Change in physical function based on health assessment questionnaire-disability index from baseline at specified timepoints (HAQ-DI)
- (and 17 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02588625 |
IM136-132 |
|
February 2016 |
October 2019 |
October 2019 |
October 28, 2015 |
July 22, 2016 |
|
- Local Institution
Scottsdale, Arizona, United States - Local Institution
Los Angeles, California, United States - Local Institution
Stanford, California, United States - (and 24 more...)
|
| 27 |
NCT01881529 |
Completed |
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma |
- Limited Scleroderma
- Diffuse Scleroderma
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Summarized the number and percentage of subjects with elevated LOXL2 levels
|
29 |
All |
18 Years and older (Adult, Senior) |
NCT01881529 |
GS-US-321-0108 |
|
April 2013 |
March 2014 |
March 2014 |
June 19, 2013 |
April 17, 2014 |
|
- St Vincent's Centre for Applied Medical Research
Darlinghurst, New South Wales, Australia
|
| 28 |
NCT00442611 |
Completed
Has Results |
A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma) |
- Scleroderma, Diffuse
- Scleroderma, Systemic
|
- Drug: Abatacept
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- Stanford University
- Bristol-Myers Squibb
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Modified Rodnan Skin Score
- Oral Aperture at Baseline and Month 6
- Hand Extension at Baseline and Month 6
- (and 3 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT00442611 |
100 186 |
|
November 2008 |
June 2011 |
June 2011 |
March 2, 2007 |
October 31, 2017 |
April 24, 2015 |
- Stanford University School of Medicine
Stanford, California, United States
|
| 29 |
NCT01538719 |
Completed |
IL1-TRAP, Rilonacept, in Systemic Sclerosis |
- Scleroderma
- Systemic Sclerosis
- Diffuse Scleroderma
- Diffuse Systemic Sclerosis
|
- Drug: Rilonacept
- Other: Placebo
|
Interventional |
Phase 1
Phase 2 |
- Boston University
- Regeneron Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- 4- gene biomarker
- Modified Rodnan Skin Score
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01538719 |
H31332 |
|
December 2011 |
January 2017 |
August 11, 2017 |
February 24, 2012 |
December 5, 2017 |
|
- Boston University Medical Center
Boston, Massachusetts, United States
|
| 30 |
NCT00016458 |
Completed |
Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis |
|
- Drug: anti-thymocyte globulin
- Drug: cyclophosphamide
|
Interventional |
Phase 2 |
- Fred Hutchinson Cancer Research Center
- Office of Rare Diseases (ORD)
|
Other |
- Primary Purpose: Treatment
|
|
20 |
All |
up to 64 Years (Child, Adult) |
NCT00016458 |
199/15818
FHCRC-1473.00 |
|
June 2000 |
|
|
May 7, 2001 |
September 3, 2008 |
|
- University of Colorado Cancer Center
Denver, Colorado, United States - Duke University Medical Center
Durham, North Carolina, United States - Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
|
| 31 |
NCT00418132 |
Terminated |
Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis |
|
- Drug: Thalidomide
- Drug: Placebo thalidomide
|
Interventional |
Phase 1 |
- New York University School of Medicine
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Collagen mRNA levels in the skin
- In vivo collagen production
- Immune function
- (and 3 more...)
|
30 |
All |
18 Years to 65 Years (Adult) |
NCT00418132 |
K23AR002187 |
|
August 2000 |
|
October 2007 |
January 4, 2007 |
March 11, 2016 |
|
- New York University School of Medicine General Clinical Research Center, Bellevue Hospital
New York, New York, United States
|
| 32 |
NCT00004380 |
Completed |
Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis |
|
|
Interventional |
Phase 2 |
- National Center for Research Resources (NCRR)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Stanford University
- Office of Rare Diseases (ORD)
|
NIH / Other |
- Allocation: Non-Randomized
- Primary Purpose: Treatment
|
|
1 |
All |
Child, Adult, Senior |
NCT00004380 |
199/12015
SUMC-37488 |
|
December 1991 |
|
December 1997 |
October 19, 1999 |
June 24, 2005 |
|
|
| 33 |
NCT02516124 |
Active, not recruiting |
EBMT ADWP Prospective Non Interventional Study : AutoHSCT in SSc Patients |
|
- Procedure: Autologous HSCT
|
Observational |
|
- European Group for Blood and Marrow Transplantation
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Progression free survival
- Safety assessed by Treatment related toxicity throughout the study period using WHO toxicity parameters (expressed as maximum grade toxicity per organ system, see appendix)
- Overall Survival
- (and 4 more...)
|
82 |
All |
18 Years to 65 Years (Adult) |
NCT02516124 |
|
NISSC |
December 2012 |
January 2018 |
March 2018 |
August 5, 2015 |
February 20, 2018 |
|
- Badoglio Manuela- EBMT Paris Office
Paris, France
|
| 34 |
NCT02283762 |
Active, not recruiting |
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis |
|
- Drug: Riociguat (Adempas, BAY63-2521)
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in mRSS (modified Rodnan skin score)
- American College of Rheumatology Combined Response Index for Systemic Sclerosis (CRISS) at Week 52
- Health Assessment Questionnaire disability index (HAQ-DI) domain (separately from the Scleroderma Health Assessment Questionnaire [SHAQ] as part of the calculation of the CRISS algorithm)
- (and 3 more...)
|
121 |
All |
18 Years and older (Adult, Senior) |
NCT02283762 |
16277
2014-001353-16 |
|
January 15, 2015 |
December 15, 2017 |
June 30, 2022 |
November 5, 2014 |
April 17, 2018 |
|
- Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States - UCLA David Geffen School of Medicine
Los Angeles, California, United States - Stanford University School of Medicine
Palo Alto, California, United States - (and 56 more...)
|
| 35 |
NCT02531009 |
Withdrawn |
Systemic Sclerosis Clinical and Biomarker Study |
- Healthy
- Systemic Sclerosis
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in University of California at Los Angeles Scleroderma Clinical Trial Consortium GI Tract (UCLA-SCTC GIT) instrument score in participants with SSc
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02531009 |
995SS001 |
|
December 2015 |
March 2017 |
March 2017 |
August 21, 2015 |
November 2, 2015 |
|
|
| 36 |
NCT01651143 |
Completed |
Proof of Biological Activity of SAR100842 in Systemic Sclerosis |
|
- Drug: SAR100842
- Drug: Placebo (for SAR100842)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety and tolerability during the 8 week treatment period (core part): Number of patients reporting adverse events
- Change from baseline to Week 8 in biomarkers obtained from blood and skin
- Change from baseline to Week 8 in Modified Rodnan Skin Score (mRSS)
- Change from baseline to Week 8 in Scleroderma Health Assessment Questionnaire (SHAQ) score
|
32 |
All |
18 Years and older (Adult, Senior) |
NCT01651143 |
ACT12339
2012-001369-34
U1111-1127-2854 |
|
January 2013 |
November 2013 |
April 2014 |
July 26, 2012 |
March 25, 2016 |
|
- Investigational Site Number 840006
Scottsdale, Arizona, United States - Investigational Site Number 840003
Washington, District of Columbia, United States - Investigational Site Number 840004
Baltimore, Maryland, United States - (and 10 more...)
|
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