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Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

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NCT01786668

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Desert Medical Imaging
Indian Wells, California, 92210 United States
See other locations
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

- Documented diagnosis of Ankylosing Spondylitis

- Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
treatment or is intolerant to NSAIDs

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

- Pregnant or lactating females

- Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any
biological agent

NCT01786668
Pfizer
Completed
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

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Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)
This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ankylosing Spondylitis
  • Drug: Tofacitinib 2 mg
    4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Drug: Tofacitinib 5 mg
    4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Drug: Tofacitinib 10 mg
    4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Drug: Placebo
    4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
  • Experimental: Tofacitinib 2 mg
    Intervention: Drug: Tofacitinib 2 mg
  • Experimental: Tofacitinib 5 mg
    Intervention: Drug: Tofacitinib 5 mg
  • Experimental: Tofacitinib 10 mg
    Intervention: Drug: Tofacitinib 10 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented diagnosis of Ankylosing Spondylitis
  • Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs

Exclusion Criteria:

  • Pregnant or lactating females
  • Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Germany,   Hungary,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   United States
 
 
NCT01786668
A3921119
2011-005689-39 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

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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1-800-718-1021

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[email protected]



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