An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555542
• Other study ID #: RA-2006-005
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2007
• Last updated: May 7, 2008
• Start date: July 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
China	Department of Medicine and Therapeutics	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes