Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Genentech

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: methotrexate; Drug: rituximab; Drug: placebo; Drug: corticosteroids

Study type: Interventional

Funder types: Industry

Identifiers

NCT00074438

WA17043

WA17043/U2644g

Details and patient eligibility

About

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Enrollment: 465 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility criteria include, but are not limited to the following:

• Are between the ages of 18 and 80 years.
• Have been diagnosed with rheumatoid arthritis for at least 6 months.
• Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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465 participants in 9 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: methotrexate

Drug: rituximab

2

Experimental group

Treatment:

Drug: methotrexate

Drug: rituximab

Drug: corticosteroids

3

Experimental group

Treatment:

Drug: methotrexate

Drug: rituximab

Drug: corticosteroids

4

Experimental group

Treatment:

Drug: methotrexate

Drug: rituximab

5

Experimental group

Treatment:

Drug: methotrexate

Drug: rituximab

Drug: corticosteroids

6

Experimental group

Treatment:

Drug: methotrexate

Drug: rituximab

Drug: corticosteroids

7

Placebo Comparator group

Treatment:

Drug: methotrexate

Drug: placebo

8

Placebo Comparator group

Treatment:

Drug: methotrexate

Drug: placebo

Drug: corticosteroids

9

Placebo Comparator group

Treatment:

Drug: methotrexate

Drug: placebo

Drug: corticosteroids