Clinical trials: Diffuse Scleroderma
Scleroderma, Diffuse, Diffuse Cutaneous Systemic Sclerosis
Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences.
- Trial name
- FASST (NCT02503644)
- Testing
- IVA337
- Where
- 49 sites in Bulgaria, France and 8 more
- Volunteers
- 145 people
- Sponsor
- Inventiva Pharma
Scleroderma, Systemic Sclerosis
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand…
- Conditions
- Scleroderma, Systemic Sclerosis, Raynaud Phenomena, Raynaud's Disease
- Trial name
- STAR (NCT02396238)
- Testing
- Celution Device
- Where
- 19 sites in United States
- Volunteers
- 88 people
- Sponsor
- Cytori Therapeutics
Raynaud's Disease, Peripheral Vascular Disease
PF-00489791 For The Treatment Of Raynaud's
The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.
- Trial name
- NCT01090492
- Testing
- PF-00489791
- Where
- 55 sites in United States, Canada and 9 more
- Volunteers
- 243 people
- Sponsor
- Pfizer
Systemic Scleroderma
Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial
1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and COMP) for the modified Rodnan skin score (MRSS).
- Trial name
- NCT02349009
- Testing
- C-82 Topical Gel, 1%
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Prism Pharma Co., Ltd.
Systemic Sclerosis
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).
- Trial name
- LOTUSS (NCT01933334)
- Testing
- Pirfenidone
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 63 people
- Sponsor
- Genentech, Inc.
Scleroderma
A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020.
- Trial name
- NCT02588625
- Testing
- BMS-986020
- Where
- 27 sites in United States, Canada and 2 more
- Sponsor
- Bristol-Myers Squibb
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).
- Trial name
- NCT02228850
- Testing
- Alprostadil
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Scleroderma
Scleroderma Treatment With Celution Processed ADRCs Registry
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.
- Trial name
- STAR (NCT02328625)
- Sponsor
- Cytori Therapeutics
Scleroderma
Post Marketing Surveillance Study of Cuprimine
Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a Compassionate Special Permit issued by the Bureau of Food and Drugs.
- Trial name
- NCT01374282
- Testing
- Cuprimine (penicillamine)
- Sponsor
- Merck Sharp & Dohme LLC
Systemic Sclerosis, Scleroderma
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases.
- Trial name
- NCT00043706
- Testing
- Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
- Where
- 4 sites in United States
- Sponsor
- Genzyme, a Sanofi Company
Scleroderma
A Study of the Safety and Tolerability of MEDI-551 in Scleroderma
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-551 over escalating single doses in adult subjects with Scleroderma
- Trial name
- NCT00946699
- Testing
- MEDI-551
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 50 people
- Sponsor
- MedImmune LLC
Limited Scleroderma, Diffuse Scleroderma
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.
- Trial name
- NCT01881529
- Where
- Australia
- Volunteers
- 29 people
- Sponsor
- Gilead Sciences
Systemic Sclerosis
Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis
This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets.
- Trial name
- DISTOL-PK (NCT00848939)
- Testing
- treprostinil diethanolamine
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Scleroderma
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
To evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
- Trial name
- MEDI-546 (NCT00930683)
- Testing
- MEDI-546
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- MedImmune LLC
Scleroderma
Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.
- Trial name
- NCT00764309
- Testing
- dasatinib
- Where
- 13 sites in United States
- Volunteers
- 47 people
- Sponsor
- Bristol-Myers Squibb
Systemic Sclerosis
AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis
To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation.
- Trial name
- NCT00769028
- Testing
- Hyperimmune caprine serum, Albumin
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Daval International Limited
Keratoconjunctivitis Sicca, Sjogren's Syndrome
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune…
- Conditions
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
- Trial name
- NCT00025818
- Testing
- Ophthalmic Emulsion
- Where
- 17 sites in United States
- Volunteers
- 290 people
- Sponsor
- Allergan
Raynaud Disease
Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
- Trial name
- NCT00934427
- Testing
- 0.9% nitroglycerin in TAM cream, vehicle cream
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- MediQuest Therapeutics
Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
- Conditions
- Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Other Autoimmune Disease
- Trial name
- NCT00577304
- Testing
- Nitroglycerin, Topical AmphiMatrix
- Where
- 17 sites in United States
- Volunteers
- 200 people
- Sponsor
- MediQuest Therapeutics
Pulmonary Hypertension
Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension
The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
- Trial name
- NCT00080457
- Testing
- sitaxsentan sodium
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Encysive Pharmaceuticals