| 1 |
NCT03198689 |
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 6 more...)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT03198689 |
BV201708 |
|
May 7, 2019 |
March 1, 2021 |
July 1, 2021 |
June 26, 2017 |
May 24, 2019 |
|
- Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada
|
|
| 2 |
NCT03398837 |
Active, not 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.
|
365 |
All |
18 Years and older (Adult, Older Adult) |
NCT03398837 |
JBT101-SSc-002 |
RESOLVE-1 |
December 18, 2017 |
March 2020 |
March 2020 |
January 16, 2018 |
July 3, 2019 |
|
- University of California San Diego
La Jolla, California, United States - Pacific Arthritis Care Center
Los Angeles, California, United States - UCLA
Los Angeles, California, United States - (and 71 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, Older Adult) |
NCT02339441 |
10H101429 |
ESOS |
June 2010 |
December 2015 |
March 2016 |
January 15, 2015 |
May 13, 2016 |
|
|
|
| 4 |
NCT02161406 |
Completed
Has Results |
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
|
- Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year
- Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12
- Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease
- (and 32 more...)
|
88 |
All |
18 Years and older (Adult, Older Adult) |
NCT02161406 |
IM101-344
1UM1AI110557 |
ASSET |
September 2014 |
September 12, 2018 |
October 17, 2018 |
June 11, 2014 |
June 18, 2019 |
June 18, 2019 |
- 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 |
Completed |
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...)
|
145 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02503644 |
IVA_01_337_HSSC_15_001 |
FASST |
October 29, 2015 |
October 2018 |
October 12, 2018 |
July 21, 2015 |
March 4, 2019 |
|
- University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski
Pleven, Bulgaria - Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, Bulgaria - University Multiprofile Hospital for Active Treatment -Kaspela
Plovdiv, Bulgaria - (and 46 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, Older Adult) |
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 |
NCT03919799 |
Recruiting |
KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis |
- System; Sclerosis
- Diffuse Cutaneous Systemic Sclerosis
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- CRISS Response at Week 24
- CRISS Response at Week 52
- Efficacy of KD025 in Comparison to Placebo at Week 24
- (and 5 more...)
|
60 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT03919799 |
KD025-209 |
|
April 2019 |
December 2021 |
May 2022 |
April 18, 2019 |
April 18, 2019 |
|
- Premier Clinical Research
Spokane, Washington, United States
|
|
| 8 |
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, Older Adult) |
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
|
|
| 9 |
NCT02465437 |
Active, not recruiting
Has Results |
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
- Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Day 85 and 113
- CRISS Individual Components (mRSS Total Score) Change From Baseline.
- (and 4 more...)
|
42 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02465437 |
JBT101-SSc-001 |
|
August 2015 |
October 2016 |
December 2021 |
June 8, 2015 |
January 29, 2019 |
October 2, 2018 |
- 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...)
|
|
| 10 |
NCT02370784 |
Active, not 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, Older Adult) |
NCT02370784 |
PRO14010170
1R21AR066305-01A1 |
TAMER |
February 2015 |
December 15, 2018 |
December 2019 |
February 25, 2015 |
March 4, 2019 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
|
| 11 |
NCT01093885 |
Completed
Has Results |
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 Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the MRSS
- Systemic Sclerosis Quality of Life Assessed by the SF-36.
|
15 |
All |
19 Years to 90 Years (Adult, Older Adult) |
NCT01093885 |
Ambrj55501. |
|
February 2010 |
July 2016 |
July 2016 |
March 26, 2010 |
November 29, 2018 |
November 29, 2018 |
- University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
|
|
| 12 |
NCT03708718 |
Recruiting |
Prednisolone in Early Diffuse Systemic Sclerosis |
|
- Drug: Prednisolone 5 mg
- Drug: Placebo oral capsule
|
Interventional
|
Phase 2 |
- Prof. Ariane herrick
- Arthritis Research UK
- University of Manchester
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Health Assessment Questionnaire Disability Index (HAQ-DI)
- modified Rodnan Skin Score (mRSS)
- Quality of life and functional ability - Assessed by Questionnaire
- (and 10 more...)
|
72 |
All |
18 Years and older (Adult, Older Adult) |
NCT03708718 |
119220 |
PRedSS |
December 21, 2017 |
June 2020 |
September 2020 |
October 17, 2018 |
October 17, 2018 |
|
- Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom - The Ulster Hospital - South Eastern Health and Social Care Trust
Belfast, County Antrim And County Down, United Kingdom - Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom - (and 9 more...)
|
|
| 13 |
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, Older Adult) |
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...)
|
|
| 14 |
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, Older Adult) |
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
|
|
| 15 |
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, Older Adult) |
NCT01670565 |
12006 |
|
August 2012 |
November 2015 |
February 2016 |
August 22, 2012 |
March 16, 2017 |
|
- Hospital for Special Surgery
New York, New York, United States
|
|
| 16 |
NCT02921971 |
Completed |
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])
|
97 |
All |
18 Years and older (Adult, Older Adult) |
NCT02921971 |
ACT14604
2016-001028-80
U1111-1179-4690 |
|
November 23, 2016 |
January 14, 2019 |
April 1, 2019 |
October 3, 2016 |
April 9, 2019 |
|
- Investigational Site Number 8400006
San Francisco, California, United States - Investigational Site Number 8400005
Washington, District of Columbia, United States - Investigational Site Number 8400002
Cleveland, Ohio, United States - (and 41 more...)
|
|
| 17 |
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, Older Adult) |
NCT00704665 |
2773 |
|
December 1998 |
December 2001 |
December 2001 |
June 25, 2008 |
June 25, 2008 |
|
|
|
| 18 |
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, Older Adult) |
NCT03222492 |
DAIT ITN075AI
ITN075AI
NIAID CRMS ID#: 38418 |
BRAVOS |
September 20, 2017 |
September 2020 |
September 2020 |
July 19, 2017 |
August 9, 2019 |
|
- 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 7 more...)
|
|
| 19 |
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, Older Adult) |
NCT00433186 |
H-25973 |
|
March 2006 |
March 2011 |
March 2011 |
February 9, 2007 |
March 31, 2011 |
|
- Boston University School of Medicine
Boston, Massachusetts, United States
|
|
| 20 |
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, Older Adult) |
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
|
|
| 21 |
NCT01785056 |
Active, not recruiting |
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, Older Adult) |
NCT01785056 |
Pro00000052 |
|
April 2013 |
January 2018 |
January 2019 |
February 6, 2013 |
July 17, 2018 |
|
- Georgetown University Hospital
Washington, District of Columbia, United States - Johns Hopkins Hospital
Baltimore, Maryland, United States
|
|
| 22 |
NCT03274076 |
Active, not 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, Older Adult) |
NCT03274076 |
HUM000131837 |
TOFA-SSc |
October 2, 2017 |
April 8, 2019 |
November 30, 2019 |
September 6, 2017 |
August 13, 2019 |
|
- University of Michigan
Ann Arbor, Michigan, United States - University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
|
| 23 |
NCT03844061 |
Recruiting |
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis |
|
- Drug: Belimumab
- Drug: Rituximab
- Other: Placebo Subcutaneous Injection
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Hospital for Special Surgery, New York
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Primary Efficacy Outcome: Change in the ACR CRISS at 12 months
- Primary Safety Outcome: The proportion of participants who experience at least one Grade 3 or higher adverse event at or before 12 months
- Proportion of patients who experience at least one grade 2 or higher adverse event
- (and 17 more...)
|
30 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03844061 |
2018-2011 |
|
July 29, 2019 |
February 28, 2022 |
February 28, 2022 |
February 18, 2019 |
August 1, 2019 |
|
- Hospital for Special Surgery
New York, New York, United States
|
|
| 24 |
NCT03831438 |
Recruiting |
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary Outcome: Incidence of treatment related adverse events
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT03831438 |
AVID200-01 |
|
January 1, 2019 |
September 30, 2019 |
October 15, 2019 |
February 5, 2019 |
April 5, 2019 |
|
- UCLA
Los Angeles, California, United States - Boston University
Boston, Massachusetts, United States - Hospital of Special Surgery
New York, New York, United States - (and 2 more...)
|
|
| 25 |
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, Older Adult) |
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
|
|
| 26 |
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, Older Adult) |
NCT02264405 |
EBMT-8410015 |
NISSC |
December 2012 |
December 2015 |
December 2017 |
October 15, 2014 |
October 20, 2014 |
|
- Badoglio Manuela- EBMT Paris Office
Paris, France
|
|
| 27 |
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, Older Adult) |
NCT01895244 |
AST MOMA |
AST-MOMA |
September 2012 |
September 2020 |
September 2022 |
July 10, 2013 |
April 18, 2019 |
|
- University Hospital Tuebingen; Department of oncology, hematology, rheumatology, immunology and pulmology
Tuebingen, Germany
|
|
| 28 |
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, Older Adult) |
NCT03041025 |
201247
2016-003417-95 |
|
June 5, 2017 |
February 28, 2020 |
February 28, 2020 |
February 2, 2017 |
June 17, 2019 |
|
- GSK Investigational Site
Los Angeles, California, United States - GSK Investigational Site
Stanford, California, United States - GSK Investigational Site
Chicago, Illinois, United States - (and 12 more...)
|
|
| 29 |
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, Older Adult) |
NCT02682511 |
CPI-IFE-004 |
|
January 2017 |
December 2020 |
February 2021 |
February 15, 2016 |
August 15, 2019 |
|
- UCLA
Los Angeles, California, United States - New Life Medical Research Center, Inc.
Hialeah, Florida, United States - Johns Hopkins University
Baltimore, Maryland, United States - (and 9 more...)
|
|
| 30 |
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, Older Adult) |
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...)
|
|
| 31 |
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, Older Adult) |
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
|
|
| 32 |
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, Older Adult) |
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
|
|
| 33 |
NCT01538719 |
Completed
Has Results |
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: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in 2- Gene Biomarker
- Change in Modified Rodnan Skin Score
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT01538719 |
H31332 |
|
December 2011 |
January 2017 |
August 11, 2017 |
February 24, 2012 |
May 1, 2018 |
May 1, 2018 |
- Boston University Medical Center
Boston, Massachusetts, United States
|
|
| 34 |
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
|
|
| 35 |
NCT00418132 |
Terminated |
Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis |
|
- Drug: Thalidomide
- Drug: Placebo thalidomide
|
Interventional
|
Phase 1 |
- NYU Langone Health
- 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, Older 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
|
|
| 36 |
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, Older Adult |
NCT00004380 |
199/12015
SUMC-37488 |
|
December 1991 |
|
December 1997 |
October 19, 1999 |
June 24, 2005 |
|
|
|
| 37 |
NCT02516124 |
Completed |
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, Older Adult) |
NCT02516124 |
|
NISSC |
December 2012 |
January 2018 |
March 2018 |
August 5, 2015 |
May 1, 2018 |
|
- Badoglio Manuela- EBMT Paris Office
Paris, France
|
|
| 38 |
NCT02283762 |
Completed
Has Results |
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 From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52
- CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
- (and 3 more...)
|
121 |
All |
18 Years and older (Adult, Older Adult) |
NCT02283762 |
16277
2014-001353-16 |
|
January 15, 2015 |
December 15, 2017 |
March 28, 2019 |
November 5, 2014 |
April 17, 2019 |
January 25, 2019 |
- 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...)
|
|
| 39 |
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, Older Adult) |
NCT02531009 |
995SS001 |
|
December 2015 |
March 2017 |
March 2017 |
August 21, 2015 |
November 2, 2015 |
|
|
|
| 40 |
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, Older Adult) |
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...)
|
|
| 41 |
NCT03630211 |
Recruiting |
Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis |
- Systemic Sclerosis
- Diffuse Sclerosis Systemic
- Interstitial Lung Disease
- Pulmonary Hypertension
|
- Drug: Cyclophosphamide
- Drug: Mesna
- Drug: Rituximab
- (and 5 more...)
|
Interventional
|
Phase 2 |
- Paul Szabolcs
- University of Pittsburgh
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- High Dose Immunoablative therapy-Safety
- Death
- Respiratory Failure
- (and 10 more...)
|
8 |
All |
16 Years to 70 Years (Child, Adult, Older Adult) |
NCT03630211 |
PRO18050360 |
SSc |
July 31, 2018 |
August 1, 2023 |
August 1, 2025 |
August 14, 2018 |
April 5, 2019 |
|
- Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States - University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
|
|
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