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

Last updated on May 11, 2018

FOR MORE INFORMATION
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, 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Complete ankylosis (fusion) of spine.

- Previous treatment with etanercept, antibody to Tumor Necrosis Factor ? (TNF?), or
other TNF? 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.

NCT00418548
Pfizer
Completed
Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis

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Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: 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
350
February 2005
Not Provided

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 ? (TNF?), or other TNF? 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.
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
 
 
NCT00418548
0881A3-314
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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