An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

The Chinese University of Hong Kong

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00555542

RA-2006-005

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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