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Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

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NCT00434044

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Must be of Chinese ancestry and living in China.

2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.

3. Active AS at time of enrollment, defined by average of visual analog scale (VAS)
values for duration and intensity of morning stiffness 30 and two of the following:
VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30;
BASFI greater than or equal to 30 (all scores on a scale of 0 to 100).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Complete ankylosis (fusion) of spine.

2. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or
other TNFa inhibitors or other biologic agents.

3. 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.

NCT00434044
Pfizer
Completed
Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

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Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
This study will represent the sponsor's first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and efficacy of etanercept compared to placebo in the treatment of patients with AS.
Multicenter, double-blind, randomized, parallel and placebo-controlled outpatient study. The study consists of 2 parts: part A is a 6-week double-blind treatment period and part B is a 6-week open-label treatment period. During part A of the study, subjects will be randomly assigned to 1 of 2 treatment regimens: 2 etanercept 25 mg or placebo once weekly, administered subcutaneously (SC). After the completion of part A, all subjects will receive 2 etanercept 25 mg once weekly. The use of placebo as a control in part A is necessary to allow a valid comparison and to provide a quantitative assessment of effect.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: Enbrel (etanercept)
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
150
June 2007
Not Provided

Inclusion Criteria:

  1. Must be of Chinese ancestry and living in China.
  2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
  3. Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness 30 and two of the following: VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30; BASFI greater than or equal to 30 (all scores on a scale of 0 to 100).

Exclusion Criteria:

  1. Complete ankylosis (fusion) of spine.
  2. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or other TNFa inhibitors or other biologic agents.
  3. 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00434044
0881A3-322
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
December 2007

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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