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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01470599




Registration number
NCT01470599
Ethics application status
Date submitted
27/10/2011
Date registered
11/11/2011
Date last updated
16/10/2017

Titles & IDs
Public title
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Scientific title
A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease
Secondary ID [1] 0 0
2011-003622-27
Secondary ID [2] 0 0
A3921086
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

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

Experimental: 5mg BID -

Experimental: 10mg BID -


Treatment: Drugs: CP-690,550
ORAL TABLET, TWICE DAILY

Treatment: Drugs: CP-690,550
ORAL TABLETS, TWICE DAILY
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjudicated Potential Cardiovascular Events
Timepoint [1] 0 0
From baseline to Week 52
Primary outcome [2] 0 0
Adjudicated Malignancy Events
Timepoint [2] 0 0
From baseline to Week 52
Primary outcome [3] 0 0
Adjudicated Hepatic Injury Events
Timepoint [3] 0 0
From baseline to Week 52
Primary outcome [4] 0 0
Adjudicated Opportunistic Infection Events
Timepoint [4] 0 0
From baseline to Week 52
Primary outcome [5] 0 0
Adjudicated Gastrointestinal (GI) Perforation Events
Timepoint [5] 0 0
From baseline to Week 52
Primary outcome [6] 0 0
Adjudicated Interstitial Lung Disease (ILD) Events
Timepoint [6] 0 0
From baseline to Week 52
Secondary outcome [1] 0 0
Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study
Timepoint [2] 0 0
Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Secondary outcome [3] 0 0
Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study
Timepoint [3] 0 0
Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Secondary outcome [4] 0 0
Time to Relapse Among Participants in Clinical Remission at Baseline
Timepoint [4] 0 0
From baseline to Week 52
Secondary outcome [5] 0 0
Observed CDAI Score by Week
Timepoint [5] 0 0
Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Secondary outcome [6] 0 0
Change From Baseline Observed CDAI Score by Week
Timepoint [6] 0 0
Weeks 8, 16, 24, 36, 48 and 52/follow-up
Secondary outcome [7] 0 0
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline
Timepoint [7] 0 0
Week 48
Secondary outcome [8] 0 0
Corticosteroid Use Over Time
Timepoint [8] 0 0
Weeks 8, 16, 24, 36 and 48
Secondary outcome [9] 0 0
Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit
Timepoint [9] 0 0
From baseline to Week 48
Secondary outcome [10] 0 0
Observed Change From Baseline in Fecal Calprotectin by Week
Timepoint [10] 0 0
Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Secondary outcome [11] 0 0
Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week
Timepoint [11] 0 0
Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
Secondary outcome [12] 0 0
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit
Timepoint [12] 0 0
Baseline and Week 48/early termination (ET)
Secondary outcome [13] 0 0
Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit
Timepoint [13] 0 0
Baseline and Week 48/ET
Secondary outcome [14] 0 0
Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (=) 170 at Week 48/ET Visit
Timepoint [14] 0 0
Week 48/ET
Secondary outcome [15] 0 0
Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category
Timepoint [15] 0 0
Week 48/ET visit
Secondary outcome [16] 0 0
Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit
Timepoint [16] 0 0
Baseline and Week 48/ET visit
Secondary outcome [17] 0 0
Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit
Timepoint [17] 0 0
Baseline and Week 48/ET visit
Secondary outcome [18] 0 0
EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit
Timepoint [18] 0 0
Baseline and Week 48/ET visit
Secondary outcome [19] 0 0
Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit
Timepoint [19] 0 0
Baseline and Week 48/ET visit
Secondary outcome [20] 0 0
EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
Timepoint [20] 0 0
Baseline and Week 48/ET visit
Secondary outcome [21] 0 0
Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit
Timepoint [21] 0 0
Baseline and Week 48/ET visit
Secondary outcome [22] 0 0
Percentage of Participants Hospitalized Due to Crohn's Disease
Timepoint [22] 0 0
From baseline to Week 52/follow-up
Secondary outcome [23] 0 0
Length of Hospitalizations Due to Crohn's Disease
Timepoint [23] 0 0
From baseline to Week 52/follow-up

Eligibility
Key inclusion criteria
* Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.
* Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.
Minimum age
18 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
* Subjects who were discontinued from the A3921084 study due to an adverse event.
* Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).

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 2
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
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Public Hospital - Kingswood
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czechia
State/province [17] 0 0
Hradec Kralove
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Králové
Country [19] 0 0
France
State/province [19] 0 0
Lille Cedex
Country [20] 0 0
France
State/province [20] 0 0
Pessac Cedex
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Kiel
Country [23] 0 0
Germany
State/province [23] 0 0
Ulm
Country [24] 0 0
Greece
State/province [24] 0 0
Kolonaki Athens
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Hungary
State/province [26] 0 0
Gyongyos
Country [27] 0 0
Hungary
State/province [27] 0 0
Szekszard
Country [28] 0 0
Israel
State/province [28] 0 0
Jerusalem
Country [29] 0 0
Israel
State/province [29] 0 0
Kfar Saba
Country [30] 0 0
Israel
State/province [30] 0 0
Tel Aviv
Country [31] 0 0
Japan
State/province [31] 0 0
Hokkaido
Country [32] 0 0
Japan
State/province [32] 0 0
Hyogo
Country [33] 0 0
Japan
State/province [33] 0 0
Miyagi
Country [34] 0 0
Japan
State/province [34] 0 0
Chiba
Country [35] 0 0
Japan
State/province [35] 0 0
Osaka
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Soeul
Country [38] 0 0
Netherlands
State/province [38] 0 0
Amsterdam
Country [39] 0 0
South Africa
State/province [39] 0 0
Durban
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Ukraine
State/province [42] 0 0
Odesa
Country [43] 0 0
Ukraine
State/province [43] 0 0
Vinnitsa

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01470599