Phase 2
N=195
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT00787202 ↗Enrolled (actual)
195
Serious AEs
5.1%
Results posted
Apr 2013
Primary outcome: Primary: Percentage of Participants With Clinical Response — 47.5; 29.6; 51.6; 63.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CP- 690 550 (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Response |
47.5; 29.6; 51.6; 63.3; 80.0 | — |
| SECONDARY Percentage of Participants With Clinical Remission |
12.2; 7.4; 35.5; 50.0; 42.2 | — |
| SECONDARY Percentage of Participants With Endoscopic Response |
55.0; 51.9; 61.3; 70.0; 82.2 | — |
| SECONDARY Percentage of Participants With Endoscopic Remission |
2.4; 7.4; 19.4; 30.0; 26.7 | — |
| SECONDARY Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12 |
5.74; 6.10; 5.82; 5.55; 5.53; -0.63 | — |
| SECONDARY Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 |
123.15; 123.81; 132.30; 134.46; 123.95; 27.75 | — |
| SECONDARY Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8 |
9.70; 18.80; 12.55; 11.32; 17.14; -0.70 | — |
| SECONDARY Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12 |
1733; 1440; 1474; 1145; 1523; -225 | — |
| SECONDARY Plasma Concentration of CP-690,550 |
1.27; 13.3; 45.5; 44.5; 3.5; 23.1 | — |
Summary
The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
Eligibility Criteria
Inclusion Criteria
- Patients must be at least 18 years of age at screening
- Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
- Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
- Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.
Exclusion Criteria
- Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
- Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
- Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon
Data sourced from ClinicalTrials.gov (NCT00787202). 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.