| November 7, 2007 |
| May 7, 2008 |
| July 2006 |
| May 2008 (final data collection date for primary outcome measure) |
| The proportion of patients who achieved a response according to the ACR 20 response criteria at 24 weeks and 54 weeks after the initial infusion [ Time Frame: wk52 ] [ Designated as safety issue: Yes ] |
| The proportion of patients who achieved a response according to the ACR 20 response criteria at 24 weeks and 54 weeks after the initial infusion [ Time Frame: wk52 ] |
| Complete list of historical versions of study NCT00555542 on ClinicalTrials.gov Archive Site |
| The proportion of patients who achieved a response according to ACR50,ACR70, physician's assessment of disease activity,patient's assessment of physical function by means of a health-assessment questionnaire(HAQ),quality of life measure by SF-36 [ Time Frame: wk52 ] [ Designated as safety issue: Yes ] |
| The proportion of patients who achieved a response according to ACR50,ACR70, physician's assessment of disease activity,patient's assessment of physical function by means of a health-assessment questionnaire(HAQ),quality of life measure by SF-36 [ Time Frame: wk52 ] |
| |
| An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis |
| B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets |
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 II |
| Interventional |
| Treatment, Open Label, Single Group Assignment |
| Rheumatoid Arthritis |
| Drug: rituximab |
| Experimental: Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. |
| |
| |
| Completed |
| 10 |
| May 2008 |
| May 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 21 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00555542 |
| Lai-Shan Tam, The Chinese University of Hong Kong |
| RA-2006-005 |
| Chinese University of Hong Kong |
|
| Principal Investigator: |
Edmund Kwok Ming LI, MD |
Chinese University of Hong Kong |
|
|
| Chinese University of Hong Kong |
| May 2008 |