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NCT01393899 · ClinicalTrials.gov registry record · Phase 2
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
A Phase 2 study of Crohn's Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT01393899: Completed Phase 2 study of Crohn's Disease, sponsored by Pfizer.
NCT01393899 is a Phase 2 study of Crohn's Disease that has completed, run by Pfizer. The registered enrollment target is 180 participants, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393899, a Phase 2 study of Crohn's Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI\<150) at Week 8.
Primary Outcome
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score \<150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based p
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CP-690,550
Study Locations (20)
Florida
- Gasteroenterology Consultants of Clearwater - Clearwater
- West Coast Endoscopy Center - Clearwater
- Clinical Research of West Florida, Inc. - Clearwater
- Shands Endoscopy Center - Gainesville
- Shands Hospital at the University of Florida - Gainesville
- Shands Medical Plaza and Cancer Center - Gainesville
- University of Florida - College of Medicine - Gainsville
- Gastroenterology Group of Naples - Naples
- Gulfshore Endoscopy Center (Endoscopies Only) - Naples
- North Florida Gastroenterology Research, LLC - Orange Park
- Internal Medicine Specialists - Orlando
California
- ACMG Endoscopy Center - Anaheim
- ACRI - Phase I, LLC - Anaheim
- Advanced Clinical Research Institute-Phase 1, LLC - Anaheim
- West Coast Clinical Trials - Cypress
- Alliance Clinical Research - Oceanside
Colorado
- Clinical Research Of The Rockies - Lafayette
Georgia
- Gastroenterology Associates of Central Georgia, LLC - Macon
Kansas
- Cotton-O'Neil Clinical Research Center, Digestive Health - Topeka
Maryland
- Chevy Chase Endoscopy Center - Chevy Chase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01393899 record still lists
NCT01393899 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01393899 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT01393899 about?
NCT01393899 is a clinical study titled "The Safety And Efficacy Of Maintenance Therapy With CP-690,550". This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI\<150) at Week 8.
What is the current status of trial NCT01393899?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2012-03. Estimated completion is 2015-07.
What conditions does trial NCT01393899 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT01393899?
The interventions under investigation include: Placebo (DRUG), CP-690,550 (DRUG).
Who is sponsoring clinical trial NCT01393899?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01393899 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01393899's enrollment target sits among peer trials
180 56th of 105 higher than 50 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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