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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01470612




Registration number
NCT01470612
Ethics application status
Date submitted
21/10/2011
Date registered
11/11/2011

Titles & IDs
Public title
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
Scientific title
A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Secondary ID [1] 0 0
2011-004581-14
Secondary ID [2] 0 0
A3921139
Universal Trial Number (UTN)
Trial acronym
OCTAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550

Experimental: CP-690,550 5 mg BID - 5 mg BID

Experimental: CP-690,550 10 mg BID - 10 mg BID


Treatment: Drugs: CP-690,550
5 mg tablets, BID, for at least 12 months

Treatment: Drugs: CP-690,550
10 mg tablets, BID, for at least 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary outcome [2] 0 0
Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary outcome [3] 0 0
Number of Participants With Laboratory Test Abnormalities
Timepoint [3] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary outcome [4] 0 0
Number of Participants With Vital Sign Abnormalities
Timepoint [4] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary outcome [5] 0 0
Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
Timepoint [5] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary outcome [6] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timepoint [6] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Primary outcome [7] 0 0
Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
Timepoint [7] 0 0
Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Secondary outcome [1] 0 0
Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
Timepoint [1] 0 0
Months 2, 12, 24 and 36
Secondary outcome [2] 0 0
Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Timepoint [2] 0 0
Months 2, 12, 24 and 36
Secondary outcome [3] 0 0
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
Timepoint [3] 0 0
Months 2, 12, 24 and 36
Secondary outcome [4] 0 0
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Timepoint [4] 0 0
Months 2, 12, 24 and 36
Secondary outcome [5] 0 0
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
Timepoint [5] 0 0
Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Secondary outcome [6] 0 0
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Timepoint [6] 0 0
Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Secondary outcome [7] 0 0
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
Timepoint [7] 0 0
Months 2, 12, 24 and 36
Secondary outcome [8] 0 0
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Timepoint [8] 0 0
Months 2, 12, 24 and 36
Secondary outcome [9] 0 0
Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Timepoint [9] 0 0
Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84

Eligibility
Key inclusion criteria
* Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
* Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/08/2020
Sample size
Target
Accrual to date
Final
944
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
Liverpool Hospital eastern Campus - Liverpool
Recruitment hospital [6] 0 0
Eastern Health, Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Gastroenterology and Hepatology Unit - Clayton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Connecticut
Country [5] 0 0
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Florida
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United States of America
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Georgia
Country [7] 0 0
United States of America
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Kansas
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Maryland
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Michigan
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Ohio
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Wisconsin
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Austria
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Innsbruck
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St. Veit an der Glan
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Wien
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Pessac
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St Priest En Jarez
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Halle
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Hannover
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Lüneburg
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Minden
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Hyogo
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Korea, Republic of
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Gyeonggi-do
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Incheon
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Korea, Republic of
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Seoul
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Riga
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Netherlands
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Amsterdam
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Groningen
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Netherlands
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Leiden
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BAY OF Plenty
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Hamilton
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Wellington
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Timis
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Bucuresti
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Serbia
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Central Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Serbia
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Zrenjanin
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Bratislava
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Nitra
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Slovakia
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Nove Mesto nad Vahom
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Slovakia
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Presov
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South Africa
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Gauteng
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South Africa
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Western CAPE
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Spain
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Barcelona
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Spain
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Madrid,
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Spain
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Madrid
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Taiwan
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Taipei City
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Ukraine
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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England
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United Kingdom
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Middlesex
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United Kingdom
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Norfolk
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United Kingdom
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W1t 7ha

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01470612