An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the effects of T cell in peripheral blood of patients with RA undergoing selective B cell depletion have not been studied. We analyze the B and T cell subsets in patients with active RA treated undergoing this form of treatment with rituximab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Age 21 or above

• Fulfilled the 1978 American college of Rheumatology(ACR) criteria for RA

• Seropositive for RF with RF>20 IU/ml

• Active disease despite treatment with at least 2 stable dose of DMARDs for at least 16 weeks, including MRX>10mg weekly

• 4 or more swollen and/or tender joints

• Stable dose of prednisolone<=12.5mg/day or NASID for at lease 4 weeks

• MTX>10mg/wk and folic acid>10 mg/wk for at lease 4 weeks

Exclusion Criteria:

• Little or no ability for self-care

• Used a DMARD other than MTX(Leflunomide should be wash-out with cholestyramine 4 weeks prior screening)

• Received intra-articular,intramuscular, or intravenous corticosteroids in the last 4 weeks

• Concurrent treatment with any biologics within 8 weeks

• Infected joint prosthesis during the previous 5 years

• Autoimmune disease other than RA(except concurrent Sjogren's syndrome), active rheumatoid vasculitis, and history of systemic disease associated with arthritis, chronic fatigue syndrome.

• Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months

• Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis

• Recurrent bacterial infections with encapsulated organisms, primary or secondary immunodeficiency

• Active tuberculosis requiring treatment within the previous 3 years

• Opportunistic infection such as herpes zoster within the previous 2 months

• Any evidence of active cytomegalovirus;active Pneumocystis Jirovecl;or drug-resistant atypical mycobacterial infection

• Known hypersensitivity to murine proteins

• Current signs or symptoms of severe,progressive,or uncontrolled renal,hepatic,haematological,gastrointestinal,endocrine,pulmonary,cardias,neurological ,or cerebral disease

• A history of lymphoproliferative disease including lymphoma or signs suggestive of disease,such as lymphadenopathy of unusual size or location(ie,lymphadenopathy nodes,in the posterior tangle of the neck,infraclavicular epitrochlear,or periaortic areas);splenomegaly

• Any know malignant disease except basal cell carcinoma currently or in the last 5 years