Ulcerative Colitis
Conditions
Interventions
Group A: about 436 people (men or women) with ulcerative colitis will undergo a screening period to verify whether they meet the elegibility criteria (if they are able to participate in the study), th
Drug
Sponsors
Hospital de Clínicas de Porto Alegre (Centro Coordenador)
Laboratórios Pfizer Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subject must be at least 18 years of age; males and females with a documented diagnosis of ulcerative colitis (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 ou intravenous), azathioprine or 6 mercaptopurine (6MP), anti TNF alpha therapy (infliximab ou adalimumab).
Exclusion criteria
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 naive); subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome(1): The proportion of subjects in remission (improvement of ulcertative colitis) at Week 8. Remission (improvement of ulcerative colitis) is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome(1): The proportion of subjects achieving mucosal healing at Week 8. Mucosal healing is defined by Mayo endoscopic subscore of 0 or 1.;Expected Outcome(2): The proportion of subjects achieving clinical response at Week 8. Clinical response is defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.;Expected Outcome(3): The proportion of subjects in endoscopic remission (improvement) at Week 8. Endoscopic remission is defined by Mayo endoscopic subscore of 0.;Expected Outcome(4): The proportion of subjects in clinical remission (improvement) at Week 8. Clinical remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point.;Expected Outcome(5): The proportion of subjects in symptomatic remission (improvement) at Week 8. Symptomatic remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscore of 0.;Expected Outcome(6): The proportion of subjects achieving deep remission (improvement) at Week 8. Deep remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a zero on both endoscopic and rectal bleeding subscores.;Expected Outcome(7): Partial Mayo scores and change from baseline over time. Partial Mayo scores will be measured by the own Mayo score.;Expected Outcome(8): Change from baseline at Week 8 in total Mayo score. This change will be measured by the own Mayo score. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactLaboratórios Pfizer Ltda Laboratórios Pfizer Ltda
Laboratórios Pfizer Ltda.
Outcome results
None listed