Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00421915

Purpose

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.

Condition	Intervention	Phase
Ankylosing Spondylitis	Drug: Enbrel (etanercept)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	84
Study Start Date:	March 2002
Estimated Study Completion Date:	August 2002

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421915

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0881A3-311
Study First Received:	January 8, 2007
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00421915 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Anti-Inflammatory Agents
Spinal Diseases
Immunologic Factors
Joint Diseases
Spondylarthropathy
TNFR-Fc fusion protein
Immunosuppressive Agents
Bone Diseases
Musculoskeletal Diseases
Analgesics, Non-Narcotic

Arthritis
Spondylitis, Ankylosing
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Spondylarthritis
Spondylitis
Spondylarthropathies
Ankylosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
TNFR-Fc fusion protein
Infection
Bone Diseases
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Spondylitis, Ankylosing
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Spondylarthritis

Spondylitis
Ankylosis
Spondylarthropathies
Spinal Diseases
Joint Diseases
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Bone Diseases, Infectious
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 09, 2009