Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00418548

Purpose

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).

Condition	Intervention	Phase
Ankylosing Spondylitis	Drug: Etanercept	Phase III

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.

Estimated Enrollment:	350
Study Start Date:	June 2004
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418548

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0881A3-314
Study First Received:	January 4, 2007
Last Updated:	January 4, 2007
ClinicalTrials.gov Identifier:	NCT00418548
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Spondylarthropathy
Arthritis
Joint Diseases
Spondylitis, Ankylosing

TNFR-Fc fusion protein
Spondylarthritis
Bone Diseases
Spondylitis
Ankylosis
Spondylarthropathies

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Infection
Immunosuppressive Agents
Pharmacologic Actions
Bone Diseases, Infectious

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009