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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01393899




Registration number
NCT01393899
Ethics application status
Date submitted
12/07/2011
Date registered
13/07/2011
Date last updated
9/01/2017

Titles & IDs
Public title
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
Secondary ID [1] 0 0
2011-001754-28
Secondary ID [2] 0 0
A3921084
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 With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
Assessment method [1] 0 0
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score \<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 anti-diarrheal 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.
Timepoint [1] 0 0
Week 26
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20
Assessment method [1] 0 0
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score \<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 extraintestinal symptoms, need for anti-diarrheal 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 [1] 0 0
Weeks 4, 8, 12 and 20
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26
Assessment method [2] 0 0
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 extraintestinal symptoms, need for anti-diarrheal 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 [2] 0 0
Weeks 4, 8, 12, 20 and 26
Secondary outcome [3] 0 0
Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26
Assessment method [3] 0 0
Clinical remission was a CDAI score \<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 extraintestinal symptoms, need for anti-diarrheal 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 [3] 0 0
Weeks 4, 8, 12, 20 and 26
Secondary outcome [4] 0 0
Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study
Assessment method [4] 0 0
Clinical remission was a CDAI score \<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 extraintestinal symptoms, need for anti-diarrheal 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 [4] 0 0
Weeks 4, 8, 12, 20 and 26
Secondary outcome [5] 0 0
Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase
Assessment method [5] 0 0
Clinical remission was a CDAI score \<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 extraintestinal symptoms, need for anti-diarrheal 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 20 and 26
Secondary outcome [6] 0 0
Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Weeks 20 and 26
Secondary outcome [7] 0 0
CDAI Score by Week
Assessment method [7] 0 0
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 wellbeing, occurrence of extraintestinal 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 [7] 0 0
Baseline and Weeks 4, 8, 12, 20 and 26
Secondary outcome [8] 0 0
Change From Baseline in CDAI Score by Week
Assessment method [8] 0 0
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 wellbeing, occurrence of extraintestinal 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 [8] 0 0
Weeks 4, 8, 12, 20 and 26
Secondary outcome [9] 0 0
Kaplan-Meier Estimate of the Rate of Time to Relapse
Assessment method [9] 0 0
Time to relapse was defined as increase in CDAI of more than (\>)100 points from the maintenance phase baseline and a CDAI score of \>220 points, or an increase to or above the baseline CDAI score in A3921083. 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 wellbeing, occurrence of extraintestinal 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 [9] 0 0
Weeks 4, 8 12, 20 and 26
Secondary outcome [10] 0 0
Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline
Assessment method [10] 0 0
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 wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Timepoint [10] 0 0
Week 26
Secondary outcome [11] 0 0
C-Reactive Protein (CRP) by Week
Assessment method [11] 0 0
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 [11] 0 0
Baseline and Weeks 4, 8, 12, 20 and 26
Secondary outcome [12] 0 0
Change From Baseline in CRP by Week
Assessment method [12] 0 0
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 [12] 0 0
Weeks 4, 8, 12, 20 and 26
Secondary outcome [13] 0 0
Fecal Calprotectin by Week
Assessment method [13] 0 0
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 [13] 0 0
Baseline and Weeks 8, 12 and 26
Secondary outcome [14] 0 0
Change From Baseline in Fecal Calprotectin by Week
Assessment method [14] 0 0
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 [14] 0 0
Weeks 8, 12 and 26
Secondary outcome [15] 0 0
Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose
Assessment method [15] 0 0
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 [15] 0 0
Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit

Eligibility
Key inclusion criteria
* Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
* Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
* Women of childbearing potential must test negative for pregnancy prior to study enrolment.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
* Subjects likely to require any type of surgery during the study period.
* Fecal culture/toxin assay indicating presence of pathogenic infection.

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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
180
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 - Melbourne
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
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
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Hradec Králové
Country [21] 0 0
France
State/province [21] 0 0
Lille Cedex
Country [22] 0 0
France
State/province [22] 0 0
Pessac Cedex
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Kiel
Country [25] 0 0
Germany
State/province [25] 0 0
Ulm
Country [26] 0 0
Greece
State/province [26] 0 0
Kolonaki Athens
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Gyongyos
Country [29] 0 0
Hungary
State/province [29] 0 0
Kaposvár
Country [30] 0 0
Hungary
State/province [30] 0 0
Szekszard
Country [31] 0 0
Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Kfar Saba
Country [33] 0 0
Israel
State/province [33] 0 0
Tel -Aviv
Country [34] 0 0
Japan
State/province [34] 0 0
Hyogo
Country [35] 0 0
Japan
State/province [35] 0 0
Miyagi
Country [36] 0 0
Japan
State/province [36] 0 0
Chiba
Country [37] 0 0
Japan
State/province [37] 0 0
Hokkaido
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
South Africa
State/province [41] 0 0
Western Cape
Country [42] 0 0
South Africa
State/province [42] 0 0
Durban
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Ukraine
State/province [45] 0 0
Donetsk
Country [46] 0 0
Ukraine
State/province [46] 0 0
Odesa
Country [47] 0 0
Ukraine
State/province [47] 0 0
Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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/NCT01393899