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Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Last updated on May 11, 2018

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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.
Show details

- 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.
Show details

- 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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Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
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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.
Not Provided
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Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
August 2002
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00421915
0881A3-311
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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