NCT00870467

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Double-blind adalimumab	Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
DRUG	Double-blind Placebo	Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
BIOLOGICAL	Open-label Adalimumab	Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
BIOLOGICAL	Open-labelAdalimumabRescue	Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-03-01
• Completion: 2011-08-01
• First posted: 2009-03-27
• Last updated: 2012-08-07
• Results posted: 2012-04-05

Locations

88 sites across 1 country: Japan