Status:
COMPLETED
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00787202
Start Date
December 1 2008
End Date
September 1 2010
Last Update
April 16 2013
Active Locations (59)
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1
Pfizer Investigational Site
Antwerp, Belgium, 2020
2
Pfizer Investigational Site
Ghent, Belgium, 9000
3
Pfizer Investigational Site
Leuven, Belgium, 3000
4
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000