A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

Sponsor
Hoffmann-La Roche
Study ID
NCT01272908
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    1000 mg intravenously on Days 1 and 15

Study Details

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Key Dates

Start date
Jul 18, 2006
Status verified
Jun 2017
Primary completion
Mar 12, 2009
Completion
Mar 12, 2009

Study Design

Enrollment
120 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm

Primary Outcome Measure

Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary [ Time Frame: Days 1, 2, 15, and 16 and Week 48 of Initial treatment period ]

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