Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Ankylosing Spondylitis

The objective of this study is to evaluate the safety and efficacy of adalimumab 40mg every other week (eow) compared to placebo in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAID) and who may have additionally failed one or more disease-modifying anti-rheumatic drug (DMARD) therapy.

Official Title

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

Conditions

Ankylosing Spondylitis

Study Type

Interventional

Study Design

Treatment, Safety/Efficacy Study

Further Details

Study Start

April 2004

Eligibility & Criteria

Inclusion Criteria:- Subjects must be >=18y/o, – meet Modified NY Criteria definition of AS, – have dx of active AS based on protocol specified criteria, – inadequate response or intolerance to >= 1 NSAID, – be able and willing to learn to self-administer sc injections. Exclusion Criteria:- Active TB, listeriosis,or HepB or any hx of HepC, hx of demyelinating disease, MS, Cancer, or lymphoproliferative disease, – Previous anti-TNF therapy, – DMARDs (other than methotrexate, hydoxychloroquine, and sulfasalazine) or intra-articular corticosteroid joint injections within 4wks, biologic or investigational therapy within 6wks, iv antibiotics within 30 days or oral antibiotics within 14 days of study dosing.

Total Enrolment

Contact Details

Gretchen Behrens 973-394-5517 (US Only) or for more information or sites email gretchen.behrens@abbott.com