A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Abbott

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Open-label Adalimumab; Biological: Double-blind adalimumab; Biological: Open-labelAdalimumabRescue; Drug: Double-blind Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870467

M06-859

Details and patient eligibility

About

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

Full description

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

Enrollment: 334 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Rheumatoid arthritis based on the American College of Rheumatology criteria
• Methotrexate or leflunomide naïve
• Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

• History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
• Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
• Joint surgery involving joints to be assessed within 8 weeks prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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334 participants in 6 patient groups, including a placebo group

DB Placebo

Placebo Comparator group

Description:

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Treatment:

Drug: Double-blind Placebo

DB adalimumab

Experimental group

Description:

Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Treatment:

Biological: Double-blind adalimumab

DB Adalimumab/OL Adalimumab

Experimental group

Description:

Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Treatment:

Biological: Double-blind adalimumab

Biological: Open-label Adalimumab

DB Placebo/OL Adalimumab

Experimental group

Description:

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Treatment:

Drug: Double-blind Placebo

Biological: Open-label Adalimumab

DB Adalimumab/RE OL Adalimumab

Experimental group

Description:

Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Treatment:

Biological: Open-labelAdalimumabRescue

Biological: Double-blind adalimumab

Biological: Open-label Adalimumab

DB Placebo/RE OL Adalimumab

Experimental group

Description:

Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Treatment:

Biological: Open-labelAdalimumabRescue

Drug: Double-blind Placebo

Biological: Open-label Adalimumab