Study Evaluating Etanercept in Patients With Ankylosing Spondylitis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00458185

Purpose

This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).

Condition	Intervention	Phase
Ankylosing Spondylitis	Drug: etanercept	Phase IV

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, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis

Further study details as provided by Wyeth:

Primary Outcome Measures:

To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.

Secondary Outcome Measures:

Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.

Enrollment:	40
Study Start Date:	August 2006
Study Completion Date:	April 2007

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, aged between 18 and 70 years of age.
BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458185

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0881A-101871
Study First Received:	April 5, 2007
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00458185
Health Authority:	Taiwan: Department of Health

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