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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-17

Study Completion Date

2012-05-16

Brief Summary

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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

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

1000 mg iv infusion on days 1 and 15

methotrexate

Intervention Type DRUG

10-25 mg weekly (oral or parenteral)

methylprednisolone

Intervention Type DRUG

100 mg iv prior to each rituximab infusion

Interventions

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rituximab [MabThera/Rituxan]

1000 mg iv infusion on days 1 and 15

Intervention Type DRUG

methotrexate

10-25 mg weekly (oral or parenteral)

Intervention Type DRUG

methylprednisolone

100 mg iv prior to each rituximab infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients \>/= 18 years of age
* rheumatoid arthritis DAS28 \>/= 3.2
* receiving treatment on an outpatient basis
* experienced an inadequate response to previous or current treatment with methotrexate

Exclusion Criteria

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
* history of or current inflammatory joint disease other than RA
* previous treatment with any cell-depleting therapies

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No