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Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Last updated on December 11, 2019

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Study Location
Contact
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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).

- Active AS (defined by the average of scores on the visual analog scale [VAS] of ≥ 30
for duration and intensity of morning stiffness and by 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).

- 18 to 70 years of age.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Complete ankylosis (fusion) of spine.

- Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNF?), or
other TNF? inhibitors.

- Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine,
sulphasalazine, or methotrexate within 4 weeks of baseline.

NCT00421915
Pfizer
Completed
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

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Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
Official Title  ICMJE Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data
Brief Summary The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.
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: Enbrel (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 12, 2007)
84
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Main inclusion criteria

  • Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
  • Active AS (defined by the average of scores on the visual analog scale [VAS] of ? 30 for duration and intensity of morning stiffness and by 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).
  • 18 to 70 years of age.

Main exclusion criteria

  • Complete ankylosis (fusion) of spine.
  • Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNF?), or other TNF? inhibitors.
  • Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.
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 NCT00421915
Other Study ID Numbers  ICMJE 0881A3-311
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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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