A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-03-31

Brief Summary

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This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

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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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

1000mg iv on days 1 and 15

Methotrexate

Intervention Type DRUG

10-25mg/week po or parenteral

Interventions

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rituximab [MabThera/Rituxan]

1000mg iv on days 1 and 15

Intervention Type DRUG

Methotrexate

10-25mg/week po or parenteral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* active rheumatoid arthritis;
* receiving outpatient treatment;
* an inadequate response, or intolerance, to \>=1 anti-TNF agent.

Exclusion Criteria

* other rheumatic autoimmune disease or inflammatory joint disease;
* concurrent treatment with any anti-TNF-alpha therapy;
* joint or osseous surgery during 8 weeks prior to recruitment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No