A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)

Genentech

Status and phase: Terminated; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: ocrelizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406419

WA20494

ACT3985g

Details and patient eligibility

About

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.

Enrollment: 1,015 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥18 years of age
• Rheumatoid arthritis for ≥ 3 months
• Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks

Exclusion criteria

• Rheumatic autoimmune disease or inflammatory joint disease, other than RA
• Prior receipt of any biologic therapy for RA
• Concurrent treatment with any DMARD (other than methotrexate)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,015 participants in 3 patient groups, including a placebo group

Placebo × 2 IV + MTX

Placebo Comparator group

Description:

Participants received two intravenous (IV) infusion matching placebo to ocrelizumab on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 milligram (mg) was administered weekly.

Treatment:

Drug: Placebo

Drug: Methotrexate

Ocrelizumab 200 mg × 2 IV + MTX

Experimental group

Description:

Participants received two IV infusion of ocrelizumab 200 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.

Treatment:

Drug: Methotrexate

Drug: ocrelizumab

Ocrelizumab 500 mg × 2 IV + MTX

Placebo Comparator group

Description:

Participants received two IV infusion of ocrelizumab 500 mg on Day 1 and Day 15. A repeat course was administered at Weeks 24 and 26. Methotrexate 7.5-25 mg was administered weekly.

Treatment:

Drug: Methotrexate

Drug: ocrelizumab