A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy (FEATURE)

Genentech

Status and phase: Terminated; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Methotrexate; Drug: Ocrelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673920

WA20496

ACT4394g

Details and patient eligibility

About

This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥ 18 years of age
• Active rheumatoid arthritis
• Inadequate treatment with any DMARD other than methotrexate

Exclusion criteria

• Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
• Concurrent treatment with any DMARD other than methotrexate
• Previous treatment with any cell-depleting therapies
• Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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314 participants in 8 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received matching placebo: * on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate) * on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)

Treatment:

Drug: Placebo

Drug: Methotrexate

Ocrelizumab 400mg

Experimental group

Description:

Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.

Treatment:

Drug: Ocrelizumab

Drug: Methotrexate

Ocrelizumab 200mg

Experimental group

Description:

Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.

Treatment:

Drug: Ocrelizumab

Drug: Methotrexate

Ocrelizumab 200mg/ Ocrelizumab 200mg

Experimental group

Description:

Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2

Treatment:

Drug: Ocrelizumab

Drug: Methotrexate

Ocrelizumab 200mg/ Ocrelizumab 400mg

Experimental group

Description:

Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2

Treatment:

Drug: Ocrelizumab

Drug: Methotrexate

Ocrelizumab 400mg/ Ocrelizumab 400mg

Experimental group

Description:

Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2

Treatment:

Drug: Ocrelizumab

Drug: Methotrexate

Placebo/ Ocrelizumab 200mg

Experimental group

Description:

Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2

Treatment:

Drug: Ocrelizumab

Drug: Placebo

Drug: Methotrexate

Placebo/ Ocrelizumab 400mg

Experimental group

Description:

Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2

Treatment:

Drug: Ocrelizumab

Drug: Placebo

Drug: Methotrexate