Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Austria
State/province [21] 0 0
Innsbruck
Country [22] 0 0
Austria
State/province [22] 0 0
St. Veit an der Glan
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Antwerpen
Country [25] 0 0
Belgium
State/province [25] 0 0
Kortrijk
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Belgium
State/province [27] 0 0
Roeselare
Country [28] 0 0
Brazil
State/province [28] 0 0
RIO Grande DO SUL
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Canada
State/province [32] 0 0
Saskatchewan
Country [33] 0 0
Colombia
State/province [33] 0 0
Antioquia
Country [34] 0 0
Croatia
State/province [34] 0 0
Zagreb
Country [35] 0 0
Czechia
State/province [35] 0 0
Hradec Kralove
Country [36] 0 0
Czechia
State/province [36] 0 0
Praha 7
Country [37] 0 0
Czechia
State/province [37] 0 0
Strakonice
Country [38] 0 0
Czechia
State/province [38] 0 0
Usti Nad Labem
Country [39] 0 0
Denmark
State/province [39] 0 0
NV
Country [40] 0 0
Denmark
State/province [40] 0 0
Aalborg
Country [41] 0 0
Denmark
State/province [41] 0 0
Aarhus C
Country [42] 0 0
Denmark
State/province [42] 0 0
Hvidovre
Country [43] 0 0
Denmark
State/province [43] 0 0
Odense C
Country [44] 0 0
Estonia
State/province [44] 0 0
Harjumaa
Country [45] 0 0
Estonia
State/province [45] 0 0
Tallinn
Country [46] 0 0
France
State/province [46] 0 0
Amiens Cedex 01
Country [47] 0 0
France
State/province [47] 0 0
Clichy
Country [48] 0 0
France
State/province [48] 0 0
Nantes
Country [49] 0 0
France
State/province [49] 0 0
Paris cedex 12
Country [50] 0 0
France
State/province [50] 0 0
Paris
Country [51] 0 0
France
State/province [51] 0 0
Pessac
Country [52] 0 0
France
State/province [52] 0 0
Reims cedex
Country [53] 0 0
France
State/province [53] 0 0
St Priest En Jarez
Country [54] 0 0
France
State/province [54] 0 0
Toulouse Cedex 9
Country [55] 0 0
Germany
State/province [55] 0 0
Schlewig Holstein
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Halle
Country [58] 0 0
Germany
State/province [58] 0 0
Hannover
Country [59] 0 0
Germany
State/province [59] 0 0
Lüneburg
Country [60] 0 0
Germany
State/province [60] 0 0
Minden
Country [61] 0 0
Germany
State/province [61] 0 0
Munich
Country [62] 0 0
Germany
State/province [62] 0 0
Ulm
Country [63] 0 0
Hungary
State/province [63] 0 0
Bekescsaba
Country [64] 0 0
Hungary
State/province [64] 0 0
Budapest
Country [65] 0 0
Hungary
State/province [65] 0 0
Debrecen
Country [66] 0 0
Hungary
State/province [66] 0 0
Gyula
Country [67] 0 0
Hungary
State/province [67] 0 0
Miskolc
Country [68] 0 0
Hungary
State/province [68] 0 0
Mosonmagyarovar
Country [69] 0 0
Hungary
State/province [69] 0 0
Pecs
Country [70] 0 0
Hungary
State/province [70] 0 0
Szeged
Country [71] 0 0
Hungary
State/province [71] 0 0
Vac
Country [72] 0 0
Israel
State/province [72] 0 0
Haifa
Country [73] 0 0
Israel
State/province [73] 0 0
Holon
Country [74] 0 0
Israel
State/province [74] 0 0
Petah Tikva
Country [75] 0 0
Italy
State/province [75] 0 0
Milano
Country [76] 0 0
Italy
State/province [76] 0 0
PA
Country [77] 0 0
Italy
State/province [77] 0 0
Catanzaro
Country [78] 0 0
Japan
State/province [78] 0 0
Aichi
Country [79] 0 0
Japan
State/province [79] 0 0
Aomori
Country [80] 0 0
Japan
State/province [80] 0 0
Chiba
Country [81] 0 0
Japan
State/province [81] 0 0
Fukuoka
Country [82] 0 0
Japan
State/province [82] 0 0
Hokkaido
Country [83] 0 0
Japan
State/province [83] 0 0
Ibaraki
Country [84] 0 0
Japan
State/province [84] 0 0
Kagoshima
Country [85] 0 0
Japan
State/province [85] 0 0
Kochi
Country [86] 0 0
Japan
State/province [86] 0 0
Miyagi
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Japan
State/province [88] 0 0
Shiga
Country [89] 0 0
Japan
State/province [89] 0 0
Tokyo
Country [90] 0 0
Japan
State/province [90] 0 0
Hiroshima
Country [91] 0 0
Japan
State/province [91] 0 0
Hyogo
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Gyeonggi-do
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Incheon
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Latvia
State/province [95] 0 0
Riga
Country [96] 0 0
Netherlands
State/province [96] 0 0
Amsterdam
Country [97] 0 0
Netherlands
State/province [97] 0 0
Groningen
Country [98] 0 0
Netherlands
State/province [98] 0 0
Leiden
Country [99] 0 0
New Zealand
State/province [99] 0 0
BAY OF Plenty
Country [100] 0 0
New Zealand
State/province [100] 0 0
Canterbury
Country [101] 0 0
New Zealand
State/province [101] 0 0
Auckland
Country [102] 0 0
New Zealand
State/province [102] 0 0
Dunedin
Country [103] 0 0
New Zealand
State/province [103] 0 0
Hamilton
Country [104] 0 0
New Zealand
State/province [104] 0 0
Wellington
Country [105] 0 0
Poland
State/province [105] 0 0
Iodzkie
Country [106] 0 0
Poland
State/province [106] 0 0
Kujawsko-pomorskie
Country [107] 0 0
Poland
State/province [107] 0 0
Mazowieckie
Country [108] 0 0
Poland
State/province [108] 0 0
Podlaskie
Country [109] 0 0
Poland
State/province [109] 0 0
Slaskie
Country [110] 0 0
Poland
State/province [110] 0 0
Krakow
Country [111] 0 0
Poland
State/province [111] 0 0
Lodz
Country [112] 0 0
Poland
State/province [112] 0 0
Sopot
Country [113] 0 0
Poland
State/province [113] 0 0
Warszawa
Country [114] 0 0
Poland
State/province [114] 0 0
Wroclaw
Country [115] 0 0
Romania
State/province [115] 0 0
Timis
Country [116] 0 0
Romania
State/province [116] 0 0
Bucuresti
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Moscow
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Nizhniy Novgorod
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Novosibirsk
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Samara
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Yaroslavl
Country [122] 0 0
Serbia
State/province [122] 0 0
Central Serbia
Country [123] 0 0
Serbia
State/province [123] 0 0
Belgrade
Country [124] 0 0
Serbia
State/province [124] 0 0
Kragujevac
Country [125] 0 0
Serbia
State/province [125] 0 0
Novi Sad
Country [126] 0 0
Serbia
State/province [126] 0 0
Zrenjanin
Country [127] 0 0
Slovakia
State/province [127] 0 0
Bratislava
Country [128] 0 0
Slovakia
State/province [128] 0 0
Nitra
Country [129] 0 0
Slovakia
State/province [129] 0 0
Nove Mesto nad Vahom
Country [130] 0 0
Slovakia
State/province [130] 0 0
Presov
Country [131] 0 0
South Africa
State/province [131] 0 0
Gauteng
Country [132] 0 0
South Africa
State/province [132] 0 0
Western CAPE
Country [133] 0 0
Spain
State/province [133] 0 0
Barcelona
Country [134] 0 0
Spain
State/province [134] 0 0
Madrid,
Country [135] 0 0
Spain
State/province [135] 0 0
Madrid
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taipei City
Country [137] 0 0
Ukraine
State/province [137] 0 0
Chernivtsi
Country [138] 0 0
Ukraine
State/province [138] 0 0
Dnipropetrovsk
Country [139] 0 0
Ukraine
State/province [139] 0 0
Kharkiv
Country [140] 0 0
Ukraine
State/province [140] 0 0
Kyiv
Country [141] 0 0
Ukraine
State/province [141] 0 0
Lviv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Odesa
Country [143] 0 0
Ukraine
State/province [143] 0 0
Uzhgorod
Country [144] 0 0
Ukraine
State/province [144] 0 0
Vinnytsia
Country [145] 0 0
Ukraine
State/province [145] 0 0
Zaporizhzhia
Country [146] 0 0
United Kingdom
State/province [146] 0 0
England
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Middlesex
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Norfolk
Country [149] 0 0
United Kingdom
State/province [149] 0 0
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.