A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• methotrexate — DRUG
  a 10-25 mg stable dose given orally or parenterally throughout study
• rituximab [MabThera/Rituxan] — DRUG
  1 g given by intravenous infusion on Days 1 and 15 of each treatment course

Study Details

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Key Dates

Start date

Jun 30, 2004

Status verified

Sep 2016

Primary completion

Jun 30, 2013

Completion

Jun 30, 2013

Study Design

Enrollment

341 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: MabThera/Rituxan

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response [ Time Frame: Baseline to the end of the retreatment period (up to 7 years, 6 months) ]

Locations (59)

Find similar trials in Mesa, AZ

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