Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
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ClinicalTrials.gov Identifier: NCT00434044 |
Recruitment Status
:
Completed
First Posted
: February 12, 2007
Last Update Posted
: December 13, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ankylosing Spondylitis | Drug: Enbrel (etanercept) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis |
Study Start Date : | February 2007 |
Actual Study Completion Date : | June 2007 |

- Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.
- ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be of Chinese ancestry and living in China.
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness 30 and two of the following: VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30; BASFI greater than or equal to 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 a (TNFa), or other TNFa 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434044
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00434044 History of Changes |
Other Study ID Numbers: |
0881A3-322 |
First Posted: | February 12, 2007 Key Record Dates |
Last Update Posted: | December 13, 2007 |
Last Verified: | December 2007 |
Additional relevant MeSH terms:
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis |
Etanercept Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |