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An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555542
First Posted: November 8, 2007
Last Update Posted: May 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese University of Hong Kong
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: July 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15.
Drug: rituximab
Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13.
Other Name: Mabthera

Detailed Description:
  • In this open labeled prospective study, we evaluate the therapeutic efficacy and peripheral blood cellular response of rituximab in 10 patients with active RA despite conventional DMARDs therapy.
  • Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13.
  • In patients who relapses following the first cycle can be repeated with the second cycle must fulfill the following conditions:

    1. Patients must have responded clinically to the first infusion with improvement
    2. Other disease modifying anti-rheumatic drugs (DMARDs) are not appropriate as determined by the investigators, either they have been on them before or are ineffective or due to side effects,
    3. Patients have a disease activity score DSA>2.6
    4. At least 24 weeks since the first infusion
    5. Neutrophil count of >1.5 X 103/mcL
  • The second infusion consists of rituximab 1000mg intravenous infusion on day 1 and day 15 as before and the same protocol of followed up every 4 weeks up to 52 weeks from the day of the first infusion.14 Premedication as standard prescription (consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton) 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab.
  Eligibility

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555542


Locations
China
Department of Medicine and Therapeutics
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Edmund Kwok Ming LI, MD Chinese University of Hong Kong
  More Information

Responsible Party: Lai-Shan Tam, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00555542     History of Changes
Other Study ID Numbers: RA-2006-005
First Submitted: November 7, 2007
First Posted: November 8, 2007
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Chinese University of Hong Kong:
B-cell
rituximab
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents