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Scleroderma, Systemic clinical trials

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NCT ID: NCT00213460 Completed - Systemic Sclerosis Clinical Trials

Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

Start date: August 2001
Phase: N/A
Study type: Observational

Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death. In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc. The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.

NCT ID: NCT00147771 Completed - Clinical trials for Scleroderma, Localized

Imiquimod in Children With Plaque Morphea

Start date: September 2005
Phase: Phase 3
Study type: Interventional

Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in children with plaque morphea.

NCT ID: NCT00129428 Completed - Keloid Clinical Trials

Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix

Start date: August 2002
Phase: Phase 1/Phase 2
Study type: Interventional

This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid (or hypertrophic scar), scleroderma, acne keloidalis nuchae, old burn scars, granuloma annulare or related conditions.

NCT ID: NCT00114530 Completed - Clinical trials for Scleroderma, Systemic

Scleroderma: Cyclophosphamide or Transplantation

SCOT
Start date: June 2005
Phase: Phase 2/Phase 3
Study type: Interventional

SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma.

NCT ID: NCT00077584 Completed - Systemic Sclerosis Clinical Trials

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

RAPIDS-2
Start date: October 2003
Phase: Phase 3
Study type: Interventional

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

NCT ID: NCT00074568 Completed - Systemic Sclerosis Clinical Trials

Scleroderma Registry

Registry
Start date: September 2000
Phase:
Study type: Observational

Scleroderma is likely caused by a combination of factors, including an external trigger (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will conduct genetic analyses for disease-related genes in patients with scleroderma and their family members (parents, brothers, and sisters).

NCT ID: NCT00070590 Completed - Pulmonary Fibrosis Clinical Trials

Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

Start date: July 2003
Phase: Phase 2/Phase 3
Study type: Interventional

Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.

NCT ID: NCT00058578 Completed - Systemic Sclerosis Clinical Trials

Stem Cell Transplant to Treat Patients With Systemic Sclerosis

Start date: June 1999
Phase: Phase 1
Study type: Interventional

Systemic 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.

NCT ID: NCT00043706 Completed - Systemic Sclerosis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis eventually causes the involved skin to harden, limiting mobility, and can also damage other organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is currently investigating a human monoclonal antibody (CAT-192) that neutralizes active TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety, tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis.

NCT ID: NCT00040651 Terminated - Systemic Sclerosis Clinical Trials

Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients

Start date: July 2002
Phase: Phase 1
Study type: Interventional

Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe SSc.