Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Enbrel (etanercept) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

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.

Official title: Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the

percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.

Secondary outcome:

To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept

compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Starting date: March 2002
Ending date: August 2002
Last updated: January 12, 2007