An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Mabthera
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell; rituximab; Rheumatoid Arthritis