To evaluate The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
Scientific Title of Study
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study of oral CP-690,550 as an induction therapy in subjects with moderate to severe Ulcerative Colitis
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
A3921094 Protocol version 30 Sep 2011
Protocol Number
NCT01465763
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Swapnali Raut
Designation
Compliance Oversight Lead
Affiliation
Pfizer Limited
Address
Manager, IRMG, Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098. Mumbai MAHARASHTRA 400102 India
Phone
91-9821415224
Fax
91-22-26525993
Email
Swapnali.raut@pfizer.com
Details of Contact Person Scientific Query
Name
Swapnali Raut
Designation
Compliance Oversight Lead
Affiliation
Pfizer Limited
Address
Manager, IRMG, Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098. Mumbai MAHARASHTRA 400102 India
Phone
91-9821415224
Fax
91-22-26525993
Email
Swapnali.raut@pfizer.com
Details of Contact Person Public Query
Name
Swapnali Raut
Designation
Compliance Oversight Lead
Affiliation
Pfizer Limited
Address
Manager, IRMG, Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098. Mumbai MAHARASHTRA 400102 India
Phone
91-9821415224
Fax
91-22-26525993
Email
Swapnali.raut@pfizer.com
Source of Monetary or Material Support
Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India
Primary Sponsor
Name
Pfizer Limited
Address
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Australia Austria Belgium Brazil Canada Colombia Croatia Czech Republic Denmark Estonia France Germany Hungary India Israel Italy Japan Latvia Netherlands New Zealand Poland Republic of Korea Romania Russian Federation Serbia Slovakia South Africa Spain Taiwan Ukraine United Kingdom United States of America
Sites of Study
No of Sites = 7
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Abhijit Chandra
Chhatrapati Shahuji Maharaj Medical University
Dept of Surgical Gastroenterology,
Chhatrapati Shahuji Maharaj Medical University,
Lucknow - 226003 U.P. India Lucknow UTTAR PRADESH
Room No. C150, Dept of Gastroenterology, Gastro Care-Gastro Intestinal Endoscopy Centre,
C-150, Shankheshwar Complex,
Sagrampura, Kailashnagar - Surat -395002,
Gujarat, India Surat GUJARAT
Gastrocare Clinic,
Opp. Dr. Bharat Parekh Hospital,
Karansinhji Main Road, Rajkot - 360001,
Gujarat, India Rajkot GUJARAT
02812235010 912812232112 mehtacn@hotmail.com
Dr Bhabadev Goswami
Institute of Digestive and Liver Diseases
Dept of Gastroenterology, Institute of Digestive and Liver Diseases,
Dispur Hospitals Pvt Ltd, Ganeshguri,
Guwahati-781006,
Assam, India Kamrup ASSAM
0361-2221962 0361-2221962 bhabadev@rediffmail.com
Dr Shrikant Mukewar
Midas Multispeciality Hospital Pvt. Ltd.
Dept of Gastroenterology, Midas Multispeciality Hospital Pvt. Ltd.
4th Floor, Midas Heights,
07, Central Bazar Road, Ramdaspeth,
Nagpur - 440010,
Maharashtra, India Nagpur MAHARASHTRA
Dept of Gastroenterology, Poona Hospital & Research Center,
27, Sadashiv Peth,
Pune - 411030,
Maharashtra, India Pune MAHARASHTRA
02024331706 912024339352 drvinaythorat@gmail.com
Dr Mukesh Kalla
S. R. Kalla Memorial Gastro & General Hospital
Room No. 103, S. R. Kalla Memorial Gastro & General Hospital ,
78, Dhuleshwar Garden, Behind HSBC Bank,
Sardar Patel Marg, C-Scheme, Jaipur - 302001
Rajasthan, India Jaipur RAJASTHAN
01415112042 911414020622 drmkalla@rediffmail.com
Details of Ethics Committee
No of Ethics Committees= 7
Name of Committee
Approval Status
Central India Medical Research Ethics Committee, Nagpur for Dr. Shrikant Mukewar
Approved
Ethical Trial Of Health In Community (ETHIC) Committee, Surat for Dr. Mayank Kabrawala
•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.
ExclusionCriteria
Details
•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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
The proportion of subjects in remission at Week 8
Time Frame: 8 Weeks
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="545" Sample Size from India="75" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
15/12/2012
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
18/04/2012
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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).
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 India.