A Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).

Outcome Description:

ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none]-100 [severe]), Total Back Pain VAS (0 [no pain]-100 [severe]), BASFI VAS (0 [easy]-100[impossible]); and Inflammation VAS (0 [none]-10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.

Outcome Time Frame:

Week 12

Safety Issue:

No

Principal Investigator

Laura Redden, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M03-607

NCT ID:

NCT00085644

Start Date:

January 2004

Completion Date:

July 2009

Related Keywords:

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing