Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders
Rheumatoid ArthritisThe objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.
Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)
Rheumatoid ArthritisThe purpose of this clinical study is to see if an experimental drug, called MM-093, is safe and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the mother and the fetus are much higher than normal. It has been observed that women with RA (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third trimester. At this time, the levels of AFP in the blood of the mother and fetus are the highest. This observation led researchers to begin examining AFP as a possible treatment for RA.
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With...
Rheumatoid ArthritisThis 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With...
Rheumatoid ArthritisThis 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid...
Rheumatoid ArthritisThe purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). In addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate...
Rheumatoid ArthritisShort Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid...
Rheumatoid ArthritisThis study will test whether positron emission tomography (PET) imaging can be used to measure blood flow to joints in patients with rheumatoid arthritis (RA). It will also compare blood flow measurements using PET with measurements obtained with magnetic resonance imaging (MRI) to determine how useful MRI is in measuring blood flow to joints. Much of the joint damage in RA is caused by the synovium-the lining of the joint. In RA, the synovium increases in size and destroys bone and cartilage. The synovium maintains its growth by forming many new small blood vessels to nourish it. New drug treatments are being developed to stop the growth of these new blood vessels. The effect of these treatments on the synovium is usually measured by performing a biopsy-removing a small piece of synovium for examination under a microscope. The biopsy requires inserting a needle into the joint to withdraw the synovial tissue. This study will see if changes in blood flow can be assessed accurately using noninvasive imaging procedures, such as PET scanning, instead of a biopsy. Patients 18 years of age and older with rheumatoid arthritis who have at least one tender and swollen knee due to synovitis may be eligible for this study. Candidates will be screened with a medical history and physical examination. Participants will have a mold made of the knee to be studied and will have routine blood tests. Women who are able to become pregnant will have a pregnancy test. All participants will then undergo PET and MRI scanning as described below: PET - A needle is used to insert a catheter (small plastic tube) into an arm vein for injection of the radioactive substance H215O. The patient lies in a doughnut-shaped machine (the PET scanner) and a quick scan is done to measure body thickness. Then, a separate scan is taken following each of six or fewer injections of H215O. Each scan lasts about 13 minutes. MRI - The patient lies on a stretcher that is moved into a cylinder containing a magnetic field (the MRI scanner). A special coil is placed over the knee to improve the quality of the images. Earplugs are worn to muffle the loud thumping sound produced by electrical switching of the magnetic fields during the imaging. A contrast agent called gadolinium is injected through a catheter into a vein to improve the quality of the images. An intercom system permits the patient to communicate with the technician at all times during the procedure.
Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin,...
Systemic SclerosisSystemic Lupus Erythematosus3 moreOBJECTIVES: I. Determine the safety and long term complications of total body irradiation in combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune disorders. II. Determine the efficacy of this treatment regimen in these patients. III. Determine the reconstitution of immunity after autologous CD34-selected PBSC transplantation in these patients. IV. Determine engraftment of autologous CD34-selected PBSC in these patients.
TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis
Juvenile Rheumatoid ArthritisUveitisThis study will investigate the safety and effectiveness of the drug TNFR:Fc to treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis. In other studies, TNFR:Fc significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis, and the Food and Drug Administration has approved the drug for that use. Because medicines for arthritis often help patients with eye inflammation, this study will examine whether TNFR:Fc can help patients with uveitis. Patients with uveitis who are not responding well to standard treatment, such as steroids, and patients who have side effects from other medicines used to treat their uveitis or have refused treatment because of possible side effects may be eligible for this study. Candidates will be screened with a medical history, physical examination, and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina), and front of the eye, including measurements of protein and inflammation. Candidates will also undergo fluorescein angiography-a procedure in which photographs are taken of the retina to see if there is any leakage in the eye's blood vessels. A blood test and joint evaluation will also be done. Study participants will be given a shot of TNFR:Fc twice a week for up to 12 months and may continue other medicines they may be taking, such as prednisone or methotrexate. They will have follow-up examinations at week two and months one, two, three and four. Those who wish to continue treatment after the fourth month can receive the drug for another eight months and will have follow-up exams at months six, nine and 12, and one month after treatment ends. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine.
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisTo evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).