A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
Overview
- Phase
- Phase 2
- Intervention
- CP- 690 550
- Conditions
- Ulcerative Colitis
- Sponsor
- Pfizer
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Clinical Response
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
15 mg BID
Intervention: CP- 690 550
10 mg BID
Intervention: CP- 690 550
3 mg BID
Intervention: CP- 690 550
0.5 mg BID
Intervention: CP- 690 550
Placebo
Intervention: placebo
Outcomes
Primary Outcomes
Percentage of Participants With Clinical Response
Time Frame: Week 8
Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
Secondary Outcomes
- Percentage of Participants With Clinical Remission(Week 8)
- Percentage of Participants With Endoscopic Response(Week 8)
- Percentage of Participants With Endoscopic Remission(Week 8)
- Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, 12)
- Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8(Baseline, Week 8)
- Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8(Baseline, Week 4, 8)
- Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, 12)
- Plasma Concentration of CP-690,550(0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8)