An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

NCT00555542 | Completed Phase 2

• 1 other identifier: RA-2006-005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

B-cell; rituximab; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  wk52

Secondary Outcomes (1)

• 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

  wk52

Study Arms (1)

1

EXPERIMENTAL

Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15.

Drug: rituximab

Interventions

rituximab DRUG

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.

Also known as: Mabthera

1

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics

Hong Kong, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Edmund Kwok Ming LI, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 8, 2007
• Study Start: July 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

CN (1)