A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
NCT01298531
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Male and female subjects aged 18 years and over at the time of consent to the study.
- Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
- Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.
- Active axial involvement defined by mini BASDAI
- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.
- Subjects who have received any previous treatment with etanercept or other TNFα
inhibitors or biologic agents.
- Subjects with a known or expected allergy, contraindication, or hypersensitivity to
etanercept or its excipients.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis | |||
Official Title ICMJE | A Multi Centre, Double Blind, Placebo-controlled Study to Evaluate the Non Steroidal Anti-inflamatory Drugs (NSAIDS) Sparing Effect of Etanercept in Adult Subjects With Axial Involvement of Spondyloarthritis | |||
Brief Summary | This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Axial Spondyloarthritis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | 90 | |||
Original Estimated Enrollment ICMJE | 80 | |||
Actual Study Completion Date ICMJE | April 2013 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01298531 | |||
Other Study ID Numbers ICMJE | B1801132 0881A1-4749 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |