Phase 3
N=547
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01458951 ↗Enrolled (actual)
547
Serious AEs
4.9%
Results posted
Jun 2016
Primary outcome: Primary: Percentage of Participants With Remission at Week 8 — 16.6; 3.6 percentage of participants — p=0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tofacitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Remission at Week 8 |
16.6; 3.6 | 0.0005 sig |
| SECONDARY Percentage of Participants Achieving Mucosal Healing at Week 8 |
28.4; 11.6 | 0.0002 sig |
| SECONDARY Percentage of Participants Achieving Clinical Response at Week 8 |
55.0; 28.6 | <0.0001 sig |
| SECONDARY Percentage of Participants With Endoscopic Remission at Week 8 |
7.0; 1.8 | 0.0425 sig |
| SECONDARY Percentage of Participants With Clinical Remission at Week 8 |
16.8; 3.6 | 0.0004 sig |
| SECONDARY Percentage of Participants With Symptomatic Remission at Week 8 |
10.7; 2.7 | 0.0090 sig |
| SECONDARY Percentage of Participants With Deep Remission at Week 8 |
5.1; 1.8 | 0.1408 |
| SECONDARY Partial Mayo Scores |
6.4; 6.4; 4.4; 5.4; 3.7; 4.8 | — |
| SECONDARY Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8 |
-2.0; -1.0; -2.7; -1.5; -3.0; -1.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Total Mayo Score at Week 8 |
9.0; 8.9; -3.7; -2.0 | <0.0001 sig |
Summary
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
Eligibility Criteria
Inclusion Criteria
- Subject must be at least 18 years of age.
- Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
- Subjects with moderately to severely active UC based on Mayo score criteria.
- Subjects must have failed or be intolerant of at least one of the following treatments for UC:
- Corticosteroids (oral or intravenous).
- Azathioprine or 6 mercaptopurine (6 MP).
- Anti TNF therapy.
Exclusion Criteria
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- Subjects with disease limited to distal 15 cm.
- Subjects without previous treatment for UC (ie, treatment naïve).
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Data sourced from ClinicalTrials.gov (NCT01458951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.