A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Sponsor
Hoffmann-La Roche
Study ID
NCT01000610
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab [MabThera/Rituxan] — DRUG
    1000 mg iv infusion on days 1 and 15
  • methotrexate — DRUG
    10-25 mg weekly (oral or parenteral)
  • methylprednisolone — DRUG
    100 mg iv prior to each rituximab infusion

Study Details

In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50

Key Dates

Start date
Mar 17, 2008
Status verified
Jun 2017
Primary completion
May 16, 2012
Completion
May 16, 2012

Study Design

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

Arms

  • Experimental: single arm

Primary Outcome Measure

Number of Participants Reporting Adverse Events (AEs) [ Time Frame: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks ]

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