A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

Genentech

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Ocrelizumab; Drug: Methylprednisolone; Drug: Methotrexate; Drug: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808210

ACT4562g

GA00931

Details and patient eligibility

About

This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 18 years
• Current treatment for RA on an outpatient basis
• Active disease
• Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
• Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons

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 (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
• Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
• Treatment with more than one prior anti-TNFα therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Ocrelizumab 200mg

Experimental group

Description:

Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.

Treatment:

Drug: Placebo

Drug: Methylprednisolone

Drug: Ocrelizumab

Drug: Methotrexate

Infliximab 5mg/kg

Active Comparator group

Description:

Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.

Treatment:

Drug: Placebo

Drug: Methylprednisolone

Drug: Infliximab

Drug: Methotrexate