A Study Of Oral CP-690550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)

This study is currently recruiting participants.

Verified May 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01458574

First received: October 21, 2011

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 21, 2011

Last Updated Date

May 2, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The proportion of subjects in remission at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01458574 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The proportion of subjects with mucosal healing at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096 [ Time Frame: week 24 & 52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

The proportion of subjects with mucosal healing at Week 52. [ Time Frame: week 52 ] [ Designated as safety issue: No ]
The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096. [ Time Frame: week 24 & 52 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Of Oral CP-690550 As A Maintenance Therapy For Ulcerative Colitis

Official Title ^ICMJE

A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Oral CP-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

Brief Summary

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP 690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP 690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Drug: Placebo
Placebo 10 mg orally (PO) twice a day (BID)
Drug: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
Drug: CP690,550
CP690,550 10 mg orally (PO) twice a day (BID)

Study Arm (s)

Placebo Comparator: Placebo Comparator
Intervention: Drug: Placebo
Experimental: CP690,550 5 mg Arm
Intervention: Drug: CP690,550
Experimental: CP690,550 10 mg Arm
Intervention: Drug: CP690,550

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

654

Estimated Completion Date

January 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
Subjects who achieved clinical response in Study A3921094 or A3921095
Women of childbearing potential must test negative for pregnancy prior to study enrollment
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

United States, Australia, Belgium, Denmark, Estonia, Germany, Japan, Korea, Republic of, Latvia, New Zealand, Romania, Slovakia, South Africa

Administrative Information

NCT Number ^ICMJE

NCT01458574

Other Study ID Numbers ^ICMJE

A3921096

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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