Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis

Wyeth

Status and phase

Completed

Phase 3

Conditions

Ankylosing Spondylitis

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00418548

0881A3-314

Details and patient eligibility

About

The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS).

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 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).

Exclusion criteria

Complete ankylosis (fusion) of spine.
Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or other TNFα inhibitors or other biologic agents.
Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
Dose of NSAID changed within 2 weeks of baseline evaluation.
Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.