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NCT01786668 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
A Phase 2 study of Ankylosing Spondylitis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT01786668: Completed Phase 2 study of Ankylosing Spondylitis, sponsored by Pfizer.
NCT01786668 is a Phase 2 study of Ankylosing Spondylitis that has completed, run by Pfizer. The registered enrollment target is 208 participants, below the 38,183-participant average among 15 other Ankylosing Spondylitis trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01786668, a Phase 2 study of Ankylosing Spondylitis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from B
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tofacitinib 2 mg
- DRUG Tofacitinib 5 mg
- DRUG Tofacitinib 10 mg
Study Locations (20)
Florida
- Arthritis & Rheumatology Associates - Clearwater
- Millennium Research - Ormond Beach
- Southwest Florida Clinical Research Center - Tampa
Nebraska
- Advanced Medical Imaging (MRI center) - Lincoln
- Arthritis Center of Nebraska (X-ray center) - Lincoln
- Physician Research Collaboration, LLC - Lincoln
North Carolina
- Charlotte Radiology/ Carolina Imaging Services - Ballantyne
- Joint and Muscle Research Institute - Charlotte
- Presbyterian Imaging - Charlotte
California
- Desert Medical Imaging - Indian Wells
- Desert Medical Advances - Palm Desert
Maryland
- Klein & Associates, M.D., P.A. - Hagerstown
- Progressive Radiology - Hagerstown
Ohio
- Paramount Medical Research & Consulting, LLC - Middleburg Heights
- Premier Physicians Centers - Westlake
Pennsylvania
- Altoona Center for Clinical Research - Duncansville
- Clinical Research Center of Reading, LLC - Wyomissing
Indiana
- Covance Central Laboratory Services,Inc - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT01786668 record still lists
NCT01786668 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 38,183-participant average among 15 other Ankylosing Spondylitis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Ankylosing Spondylitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01786668 names 20 study sites across 10 states, led by Florida, Nebraska, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01786668 about?
NCT01786668 is a clinical study titled "Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis". 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.
What is the current status of trial NCT01786668?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2013-04. Estimated completion is 2015-03.
What conditions does trial NCT01786668 study?
This clinical trial studies the following conditions: Ankylosing Spondylitis.
What interventions are being tested in trial NCT01786668?
The interventions under investigation include: Placebo (DRUG), Tofacitinib 2 mg (DRUG), Tofacitinib 5 mg (DRUG), Tofacitinib 10 mg (DRUG).
Who is sponsoring clinical trial NCT01786668?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01786668 being conducted?
This trial has 20 study locations across California, Florida, Indiana, Maryland, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01786668's enrollment target sits among peer trials
208 13th of 15 higher than 3 of 15 other Ankylosing Spondylitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ankylosing Spondylitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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