The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.
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| Descriptive Information | ||||
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| Brief Title ICMJE | An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis | |||
| Official Title ICMJE | An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis | |||
| Brief Summary | The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU. | |||
| Detailed Description | This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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| Condition ICMJE | Ankylosing Spondylitis | |||
| Intervention ICMJE | Drug: Etanercept | |||
| Study Arms | Not Provided | |||
| Publications * | Dijkmans B, Emery P, Hakala M, Leirisalo-Repo M, Mola EM, Paolozzi L, Salvarani C, Sanmarti R, Sibilia J, Sieper J, Van Den Bosch F, van der Heijde D, van der Linden S, Wajdula J. Etanercept in the longterm treatment of patients with ankylosing spondylitis. J Rheumatol. 2009 Jun;36(6):1256-64. doi: 10.3899/jrheum.081033. Epub 2009 May 1. Erratum in: J Rheumatol. 2010 Oct;37(10):2198. | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 84 | |||
| Estimated Completion Date | July 2004 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE |
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| Sex/Gender |
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| Ages | 18 Years to 66 Years (Adult, Senior) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00421980 | |||
| Other Study ID Numbers ICMJE | 0881A3-312 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | January 2007 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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