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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4 - Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
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 - Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
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 - Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
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 - Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
Timepoint [4] 0 0
Baseline, Weeks 2, 4, and 8
Secondary outcome [5] 0 0
CDAI Scores at Weeks 2, 4, and 8 - CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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 - The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Timepoint [6] 0 0
Weeks 2, 4, and 8
Secondary outcome [7] 0 0
Calprotectin Fecal Concentrations at Weeks 2, 4, and 8 - Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.
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 - Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.
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 - The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QOL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.
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) - IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL.
Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (a) treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size.
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 - The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.
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 - The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.
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 - The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.
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 - The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.
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 - The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.
Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
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 - EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state.
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 - EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFa treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
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 - EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
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 - EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors.
The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size.
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
Gender
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
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)
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
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
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
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New Hampshire
Country [14] 0 0
United States of America
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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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United States of America
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Texas
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United States of America
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Utah
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United States of America
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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
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
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Quebec
Country [28] 0 0
Croatia
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Rijeka
Country [29] 0 0
Croatia
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Zagreb
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Czech Republic
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Hradec Kralove
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Hradec Králové
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France
State/province [32] 0 0
Lille Cedex
Country [33] 0 0
France
State/province [33] 0 0
Pessac
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France
State/province [34] 0 0
Reims cedex
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
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Germany
State/province [36] 0 0
Kiel
Country [37] 0 0
Germany
State/province [37] 0 0
Minden
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Germany
State/province [38] 0 0
Ulm
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Greece
State/province [39] 0 0
Kolonaki Athens
Country [40] 0 0
Hungary
State/province [40] 0 0
Budapest
Country [41] 0 0
Hungary
State/province [41] 0 0
Gyongyos
Country [42] 0 0
Hungary
State/province [42] 0 0
Kaposvar
Country [43] 0 0
Hungary
State/province [43] 0 0
Szekszard
Country [44] 0 0
Israel
State/province [44] 0 0
Jerusalem
Country [45] 0 0
Israel
State/province [45] 0 0
Kfar-Saba
Country [46] 0 0
Israel
State/province [46] 0 0
Petach Tikva
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Aviv
Country [48] 0 0
Japan
State/province [48] 0 0
Fukuoka
Country [49] 0 0
Japan
State/province [49] 0 0
Hokkaido
Country [50] 0 0
Japan
State/province [50] 0 0
Hyogo
Country [51] 0 0
Japan
State/province [51] 0 0
Miyagi
Country [52] 0 0
Japan
State/province [52] 0 0
Tokyo
Country [53] 0 0
Japan
State/province [53] 0 0
Chiba
Country [54] 0 0
Japan
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Osaka
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Korea, Republic of
State/province [55] 0 0
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
State/province [58] 0 0
Durban
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Spain
State/province [59] 0 0
Madrid
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Spain
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Barcelona
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Ukraine
State/province [61] 0 0
Dnipropetrovsk
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Ukraine
State/province [62] 0 0
Donetsk
Country [63] 0 0
Ukraine
State/province [63] 0 0
Kharkiv
Country [64] 0 0
Ukraine
State/province [64] 0 0
Lviv
Country [65] 0 0
Ukraine
State/province [65] 0 0
Odesa
Country [66] 0 0
Ukraine
State/province [66] 0 0
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/show/NCT01393626
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

Summary results
Other publications