Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis
NCT00418548
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- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
- Complete ankylosis (fusion) of spine.
- Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or
other TNFα 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.
- Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
- Dose of NSAID changed within 2 weeks of baseline evaluation.
- Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline
evaluation.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis | |||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis | |||
| Brief Summary | The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Ankylosing Spondylitis | |||
| Intervention ICMJE | Drug: Etanercept | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Baraliakos X, Szumski A, Koenig AS, Jones H. The role of C-reactive protein as a predictor of treatment response in patients with ankylosing spondylitis. Semin Arthritis Rheum. 2019 Jun;48(6):997-1004. doi: 10.1016/j.semarthrit.2018.10.019. Epub 2018 Nov 2. | |||
* 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 | |||
| Enrollment ICMJE | 350 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | February 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00418548 | |||
| Other Study ID Numbers ICMJE | 0881A3-314 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| 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 | January 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||