Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

Sponsor
Mashhad University of Medical Sciences
Study ID
NCT01593332
Phase
PHASE4
Status
Completed

Conditions

  • DMARD Resistant Rheumatoid Arthritis

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    two 500 mg rituximab infusions 2 weeks apart
  • Rituximab — DRUG
    500mg,two times with two weeks interval

Study Details

In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.

Key Dates

Start date
Jul 31, 2010
Status verified
May 2012
Primary completion
Sep 30, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
44 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
  • Active Comparator: Methotrexate

Primary Outcome Measure

change in 28-joint disease activity index( DAS28) [ Time Frame: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks. ]