Who is sponsoring NCT00870467?

NCT00870467 is sponsored by Abbott.

What condition does NCT00870467 study?

NCT00870467 studies Rheumatoid Arthritis.

What drugs are being tested in NCT00870467?

Interventions: Double-blind adalimumab, Double-blind Placebo, Open-label Adalimumab, Open-labelAdalimumabRescue.

What is the status of NCT00870467?

NCT00870467 is currently COMPLETED.

Last reviewed 2012-08-01 · How we verify

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

NCT00870467 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Abbott
Phase	Phase 3
Status	COMPLETED
Enrolment	334
Start date	2009-03
Completion	2011-08

Conditions

Rheumatoid Arthritis

Interventions

Double-blind adalimumab
Double-blind Placebo
Open-label Adalimumab
Open-labelAdalimumabRescue

Primary outcomes

Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 — Baseline, Week 26
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.

Countries

Japan