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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01393626




Registration number
NCT01393626
Ethics application status
Date submitted
11/07/2011
Date registered
13/07/2011
Date last updated
28/04/2017

Titles & IDs
Public title
A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
Secondary ID [1] 0 0
2011-001733-16
Secondary ID [2] 0 0
A3921083
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 - Placebo
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550

Placebo comparator: Placebo BID -

Experimental: 5mg BID -

Experimental: 10mg BID -


Treatment: Drugs: Placebo
oral tablets twice daily

Treatment: Drugs: CP-690,550
oral tablets 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
Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4
Timepoint [1] 0 0
Weeks 2 and 4
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8
Timepoint [2] 0 0
Baseline, Weeks 2, 4, and 8
Secondary outcome [3] 0 0
Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8
Timepoint [3] 0 0
Baseline, Weeks 2, 4, and 8
Secondary outcome [4] 0 0
Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8
Timepoint [4] 0 0
Baseline, Weeks 2, 4, and 8
Secondary outcome [5] 0 0
CDAI Scores at Weeks 2, 4, and 8
Timepoint [5] 0 0
Weeks 2, 4, and 8
Secondary outcome [6] 0 0
C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8
Timepoint [6] 0 0
Weeks 2, 4, and 8
Secondary outcome [7] 0 0
Calprotectin Fecal Concentrations at Weeks 2, 4, and 8
Timepoint [7] 0 0
Weeks 2, 4, and 8
Secondary outcome [8] 0 0
Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit
Timepoint [8] 0 0
Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit
Secondary outcome [9] 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 8/ET Visit
Timepoint [9] 0 0
Baseline, Week 8/ET visit
Secondary outcome [10] 0 0
Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)
Timepoint [10] 0 0
Baseline, Week 8/ET visit
Secondary outcome [11] 0 0
Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (=) 170 at Week 8/ET Visit
Timepoint [11] 0 0
Week 8/ET visit
Secondary outcome [12] 0 0
Percentage of Participants With =16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit
Timepoint [12] 0 0
Week 8/ET visit
Secondary outcome [13] 0 0
Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category
Timepoint [13] 0 0
Week 8/ET visit
Secondary outcome [14] 0 0
Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit
Timepoint [14] 0 0
Baseline, Week 8/ET visit
Secondary outcome [15] 0 0
Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA
Timepoint [15] 0 0
Baseline, Week 8/ET visit
Secondary outcome [16] 0 0
EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit
Timepoint [16] 0 0
Baseline, Week 8/ET visit
Secondary outcome [17] 0 0
Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA
Timepoint [17] 0 0
Baseline, Week 8/ET visit
Secondary outcome [18] 0 0
EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
Timepoint [18] 0 0
Baseline, Week 8/ET visit
Secondary outcome [19] 0 0
Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA
Timepoint [19] 0 0
Baseline, Week 8/ET visit

Eligibility
Key inclusion criteria
* Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
* Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
* Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
* Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
* Subjects receiving the following treatment for Crohn's disease:
* Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
* Anti-TNFa therapy within 8 weeks prior to baseline.
* Interferon therapy within 8 weeks prior to baseline.
* Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
* Intravenous corticosteroids within 2 weeks prior to baseline.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Public Hospital - Kingswood
Recruitment hospital [2] 0 0
Monash Medical Center - 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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Michigan
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New Hampshire
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Texas
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Utah
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Virginia
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United States of America
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Wisconsin
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Ontario
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Canada
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Quebec
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Croatia
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Rijeka
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Croatia
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Zagreb
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Czech Republic
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Hradec Kralove
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Czech Republic
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Hradec Králové
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France
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Lille Cedex
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France
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Pessac
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France
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Reims cedex
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Germany
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Berlin
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Germany
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Kiel
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Germany
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Minden
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Germany
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Ulm
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Greece
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Kolonaki Athens
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Hungary
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Budapest
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Hungary
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Gyongyos
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Hungary
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Kaposvar
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Hungary
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Szekszard
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Miyagi
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Tokyo
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Japan
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Chiba
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Japan
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Osaka
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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South Africa
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Western Cape
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South Africa
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Durban
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Spain
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Madrid
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Spain
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Barcelona
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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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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Vinnitsa

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

Ethics approval
Ethics application status

Summary
Brief summary
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).
Trial website
https://clinicaltrials.gov/study/NCT01393626
Trial related presentations / publications
Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01393626