NCT01465763|CompletedPhase 3ResultsDMC

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

OCTAVE

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

Pfizer ClinicalTrials.gov

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3 other identifiers

A39210942011-004578-27OCTAVEINDUCTION1

Study Type

interventional

Target

614

Locations

26 countries

Sites

173

Timeline

RegisteredNov 2011

StartedApr 2012

CompletionMay 2015

Brief Summary

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

614

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Apr 2012

Typical duration for phase_3

Geographic Reach

26 countries

173 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

October 21, 2011

Completed

17 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed

5 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 7, 2016

Completed

Last Updated

June 7, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

October 21, 2011

Results QC Date

May 1, 2016

Last Update Submit

May 1, 2016

Conditions

Ulcerative Colitis

Keywords

tofacitinibCP-690550Moderate to severe ulcerative colitisphase 3 clinical trialMayo score

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Remission at Week 8
Remission in participants was 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. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Week 8

Secondary Outcomes (9)

Percentage of Participants Achieving Mucosal Healing at Week 8
Week 8
Percentage of Participants Achieving Clinical Response at Week 8
Week 8
Percentage of Participants With Endoscopic Remission at Week 8
Week 8
Percentage of Participants With Clinical Remission at Week 8
Week 8
Percentage of Participants With Symptomatic Remission at Week 8
Week 8
+4 more secondary outcomes

Study Arms (2)

tofacitinib 10 mg BID

EXPERIMENTAL

Drug: tofacitinib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

tofacitinibDRUG

10 mg oral BID

Also known as: CP-690,550

tofacitinib 10 mg BID

PlaceboDRUG

Plabebo oral BID

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:
Corticosteroids (oral or intravenous).
Azathioprine or 6 mercaptopurine (6 MP).
Anti TNF-alpha therapy.

You may not qualify if:

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 naïve).
Subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (178)

Internal Medicine Center, LLC

Mobile, Alabama, 36608, United States

Location

Springhill Memorial Hospital

Mobile, Alabama, 36608, United States

Location

Investigational Drug Service Pharmacy

La Jolla, California, 92093, United States

Location

UCSD Medical Center

La Jolla, California, 92093, United States

Location

UCSD Medical Centre

La Jolla, California, 92093, United States

Location

Cedars Sinai Medical Center - Thalians Bldg