Gastroesophageal Reflux Treatment in Scleroderma
Gastroesophageal Reflux DiseaseSystemic Sclerosis1 moreThe investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial...
Systemic SclerosisPSSc-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).
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon...
Systemic SclerosisRaynaud DiseaseOBJECTIVES: I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.
A Study of the Safety and Tolerability of MEDI-551 in Scleroderma
SclerodermaThe 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
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants...
Systemic SclerosisSclerodermaThis study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis. Other purposes of the study were to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated by testing the drug level in the blood (pharmacokinetics).
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
Systemic SclerosisPurpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma
Stem Cell Transplant to Treat Patients With Systemic Sclerosis
Systemic SclerosisSystemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs. It is possible, that by changing the immune system we can modify the progression of this disease. Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. In this study, we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem cells, select specific cells, and store them. We will then give high dose chemotherapy that will destroy the patients immune system. We will then give back the selected stem cells we collected. We believe that these selected stem cells may be able to "re-create" the immune system without the portion that causes Systemic Sclerosis. The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis. We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis. We hope that this treatment will help to relieve the symptoms patients are experiencing, although we do not know if it will.
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With...
SclerodermaTo evaluate the safety and tolerability of a multiple-dosed drug (MEDI-546) in adults with scleroderma.
Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers
Systemic SclerosisThe objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are: • Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life? Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if: • Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?
Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
SclerodermaDiffuse1 moreSystemic 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. IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the treatment they are receiving and will be randomized to one of three treatment arms , either IVA337 400mg bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that time assessments will be made to monitor both the efficacy and safety of the treatment.