Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
NCT00420238
Last updated date
ABOUT THIS STUDY
Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe
and advanced ankylosing spondylitis.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Active and severe ankylosing spondylitis
- Ankylosing spondylitis refractory to standard anti-rheumatic treatment
- Between 18 and 70 years of age
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior exposure to any TNF-inhibitor, including etanercept
- DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks
of study drug initiation
- Dose of NSAIDs changed within two weeks of study drug initiation
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Advanced Information
| Descriptive Information | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis | |||||||||||||||
| Official Title ICMJE | A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis | |||||||||||||||
| Brief Summary | Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis. | |||||||||||||||
| Detailed Description | Not Provided | |||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||
| Study Phase ICMJE | Phase 4 | |||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||||||||||||||
| Condition ICMJE | Ankylosing Spondylitis | |||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
| |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||
| Recruitment Information | ||||||||||||||||
| Recruitment Status ICMJE | Completed | |||||||||||||||
| Actual Enrollment ICMJE | 82 | |||||||||||||||
| Original Enrollment ICMJE | 80 | |||||||||||||||
| Actual Study Completion Date ICMJE | May 2009 | |||||||||||||||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||||||||||||||
| Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
| |||||||||||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
| Listed Location Countries ICMJE | France, Germany, Hungary, Netherlands | |||||||||||||||
| Removed Location Countries | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number ICMJE | NCT00420238 | |||||||||||||||
| Other Study ID Numbers ICMJE | 0881A3-403 | |||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||
| Investigators ICMJE |
| |||||||||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||
| Verification Date | June 2010 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||