Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Wyeth

Status and phase

Completed

Phase 3

Conditions

Ankylosing Spondylitis

Treatments

Drug: Enbrel (etanercept)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00421915

0881A3-311

Details and patient eligibility

About

The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria

Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
Active AS (defined by the average of scores on the visual analog scale [VAS] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
18 to 70 years of age.

Main exclusion criteria

Complete ankylosis (fusion) of spine.
Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors.
Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.