BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)
Rheumatoid ArthritisThis study is to observe the long-term treatment of BG9924
Stem Cell Support in Patients With Rheumatoid Arthritis
RHEUMATOID ARTHRITISRheumatoid arthritis (RA) is a chronic illness, immunologically mediated, probably induced by the exposure to an antigen or antigens, to which immunologic tolerance is lost. The disease has a variable course, from a mild, intermittently symptomatic illness requiring only symptomatic therapy to a fulminant illness requiring dangerous immunosuppressive therapy, surgery or both. The molecular defect causing RA has not been characterized, but may involve aberrant T cell, B cell, and macrophage function. Although RA often responds to immunosuppressive medication including corticosteroids, methotrexate, azathioprine and cyclophosphamide, or to non-steroidal anti-inflammatory drugs, no therapy has been curative. In patients with severe RA, who have been unresponsive to corticosteroids, and who have more than 20 active joints or vasculitis, we propose, as a phase I-II study, complete immune ablation and subsequent reconstitution with autologous in vitro T lymphocyte depleted PBSCs harvested from the patient prior to immune ablation. The combination of high dose cyclophosphamide and anti-thymocyte globulin conditioning will be followed by rescue with autologous lymphocyte depleted PBSCs. Subsequent disease activity will be followed by: (1) RA disease activity index, (2) type and amount of therapy for RA, and (3) flow cytometry of peripheral blood lymphocyte subsets, (4) joint count, (5) patients' assessment of pain, (6) arthritis impact measurement scales (AIMS) questionnaire, (7) acute phase reactants. This study will dose standard therapy, i.e. immune suppression, to the point of complete immune ablation and subsequent recapitulation of lymphocyte ontogeny by PBSC rescue. We anticipate that this study will also form the basis to clarify further the role of the immune system in RA.
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
Myasthenia GravisSystemic Lupus Erythematosus1 moreThe aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
OsteoarthritisArthritis4 moreThe purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid...
Rheumatoid ArthritisOPERA aims to better understand and predict the responsiveness of rheumatoid arthrits (RA) patients to biological disease modifying anti-rheumatic drugs (bDMARDs). Our objectives will be (i) to determine, at baseline, the differences of oxylipin response between responders vs non-responders to Anti-Tumor necrosis factor (Anti TNF) and (ii) to investigate the relationships between the oxylipin response, the polyunsatured fatty acid (PUFA) content of immune cells and the cytokine response.
Treatment of Rheumatoid Hand With Magnetotherapy
Rheumatoid ArthritisHand RheumatismBrief Summary: Participants with rheumatoid arthritis with recommendation to physiotherapy. Created 2 study groups: Kinesiotherapy with static magnetic field Kinesiotherapy with low-frequency pulsed magnetic field Pulsed magnetic field give better effects then static magnetic field.
Scintigraphy for Prediction In Rheumatoid Intentional Therapy Tapering
Rheumatoid ArthritisThe goal of this observational study is to investigate whether 99mTc-maraciclatide imaging prior to biologic therapy tapering and after 3 months can predict those at risk of Rheumatoid arthritis flare. Participants undergoing routine tapering of biologic drug therapy will have 99mTc-maraciclatide imaging in addition to normal ultrasound imaging and then followed up over 12 months to assess whether an interval scan alone or in combination with the baseline scan is predictive of flare.
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients...
Rheumatoid ArthritisThe study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
Vitamin D Effect in Rheumatoid Arthritis.
Active Rheumatoid ArthritisRegulatory T (Tregs) cells play an important role in the maintenance of immunological tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis. Vitamin D supplementation significantly enhances Tregs percentage in the peripheral blood of RA patients. So supplementation of Vit D improves rheumatoid arthritis disease activity.
Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active...
ArthritisRheumatoidThis is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group, placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into the study, following a screening period of up to four weeks. The total treatment period is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in combination with MTX (at a weekly dose between 15-25 milligram [mg]), previously received for at least 12 weeks, with a stable and tolerated dose and route of administration for >=4 weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that do not achieve adequate disease improvement.