Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00418548
Previous Study | Return to List | Next Study

Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00418548
Recruitment Status : Completed
First Posted : January 5, 2007
Last Update Posted : January 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 4, 2007
First Posted Date  ICMJE January 5, 2007
Last Update Posted Date January 5, 2007
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2007)
The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: January 4, 2007)
350
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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