To evaluate The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

Phase 3

Not yet recruiting

• Conditions: Ulcerative Colitis

• Registration Number: CTRI/2012/12/003186
• Lead Sponsor: Pfizer Limited

Brief Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group, multi-center study in subjects with moderately to severely active ulcerative colitis. This study consists of a screening period up to three weeks, and a 9-week double-blind treatment period with the final complete evaluation at Week 8 followed by a 4-week safety follow-up for subjects who are not participants in a maintenance study (A3921096) or an open label study (A3921139).xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Approximately 545 subjects in total will be enrolled into the study. After the screening period, subjects who meet the inclusion and exclusion criteria at the baseline visit will be randomly assigned to receive one of three treatments of CP-690,550 10 mg BID, 15 mg BID, or matched placebo BID at a 2:2:1 allocation ratio. Subjects will be stratified based on the status of prior treatment with anti-TNF therapy, steroid use at baseline and geographic region. Subjects will receive double-blind treatment for 9 weeks.

Subjects who complete the double-blind treatment and achieve clinical response at Week 8 are eligible to enter a double-blind maintenance study (A3921096). 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 rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.

Subjects who complete the double-blind treatment and do not achieve clinical response are eligible to enter an open label study (A3921139).

Subjects who are early withdrawals from the study or who are not transferred into the maintenance study or open label study will have a 4-week safety follow-up after the last dose of study medication.

The study will be conducted in 7 centers in xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2012-05-12
• Study Start: 2012-12-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 545

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: •Oral corticosteroids.
• •Azathioprine or 6 mercaptopurine (6 MP).
• •Anti TNF-alpha therapy.

Exclusion Criteria

• •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects in remission at Week 8	Time Frame: 8 Weeks

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects achieving mucosal healing at Week 8.	Time Frame: 8 Weeks
The proportion of subjects achieving clinical response at Week 8.	Time Frame: 8 Weeks
The proportion of subjects in clinical remission at Week 8.	Time Frame: 8 Weeks
The proportion of subjects in symptomatic remission at Week 8.	Time Frame: 8 Weeks
The proportion of subjects achieving deep remission at Week 8.	Time Frame: 8 Weeks
Partial Mayo scores and change from baseline over time.	Time Frame: 8 Weeks
Change from baseline at Week 8 in total Mayo score.	Time Frame: 8 Weeks

Trial Locations

Locations (7)

Chhatrapati Shahuji Maharaj Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Gastro Care-Gastro Intestinal Endoscopy Centre; 🇮🇳 Surat, GUJARAT, India

Gastrocare Clinic; 🇮🇳 Rajkot, GUJARAT, India

Institute of Digestive and Liver Diseases; 🇮🇳 Kamrup, ASSAM, India

Midas Multispeciality Hospital Pvt. Ltd.; 🇮🇳 Nagpur, MAHARASHTRA, India

Poona Hospital & Research Center; 🇮🇳 Pune, MAHARASHTRA, India

S. R. Kalla Memorial Gastro & General Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Chhatrapati Shahuji Maharaj Medical University

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Abhijit Chandra

Principal investigator

abhiiitchandra@hotmail.com