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A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470599
First Posted: November 11, 2011
Last Update Posted: October 16, 2017
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: June 20, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Drug: CP-690,550

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted in participants who completed the 26-week maintenance treatment of Study A3921084 or who withdrew early due to A3921084 study treatment failure according to prespecified criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assigned to either the 5 milligram (mg) twice daily (BID) or 10 mg BID treatment group according to clinical remission status as assessed by Crohn’s Disease Activity Index (CDAI) score at the end of the A3921084 study treatment visit or early termination visit due to A3921084 study treatment failure.

Reporting Groups
  Description
Tofacitinib 5 mg BID Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
Tofacitinib 10 mg BID Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.

Participant Flow:   Overall Study
    Tofacitinib 5 mg BID   Tofacitinib 10 mg BID
STARTED   62   88 
COMPLETED   43   45 
NOT COMPLETED   19   43 
Did not meet entrance criteria                1                0 
Lost to Follow-up                2                1 
Withdrawal by Subject                3                4 
Other                1                0 
Protocol Violation                3                1 
Adverse event related to study drug                2                5 
Insufficient clinical response                6                27 
Adverse event not related to study drug                1                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis set (SAS) consisted of all participants enrolled in this open label (OL) extension study who received at least 1 dose of study medication.

Reporting Groups
  Description
Tofacitinib 5 mg BID Tofacitinib 5 mg tablet for oral administration at a dose of 5 mg BID for up to 48 weeks.
Tofacitinib 10 mg BID Tofacitinib 10 mg tablets (2 x 5 mg tablets) for oral administration at a dose of 10 mg BID for up to 48 weeks.
Total Total of all reporting groups

Baseline Measures
   Tofacitinib 5 mg BID   Tofacitinib 10 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   88   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.0  (12.6)   38.2  (11.6)   39.4  (12.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      30  48.4%      41  46.6%      71  47.3% 
Male      32  51.6%      47  53.4%      79  52.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjudicated Potential Cardiovascular Events   [ Time Frame: From baseline to Week 52 ]

2.  Primary:   Adjudicated Malignancy Events   [ Time Frame: From baseline to Week 52 ]

3.  Primary:   Adjudicated Hepatic Injury Events   [ Time Frame: From baseline to Week 52 ]

4.  Primary:   Adjudicated Opportunistic Infection Events   [ Time Frame: From baseline to Week 52 ]

5.  Primary:   Adjudicated Gastrointestinal (GI) Perforation Events   [ Time Frame: From baseline to Week 52 ]

6.  Primary:   Adjudicated Interstitial Lung Disease (ILD) Events   [ Time Frame: From baseline to Week 52 ]

7.  Secondary:   Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48   [ Time Frame: Week 48 ]

8.  Secondary:   Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study   [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]

9.  Secondary:   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   [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]

10.  Secondary:   Time to Relapse Among Participants in Clinical Remission at Baseline   [ Time Frame: From baseline to Week 52 ]

11.  Secondary:   Observed CDAI Score by Week   [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]

12.  Secondary:   Change From Baseline Observed CDAI Score by Week   [ Time Frame: Weeks 8, 16, 24, 36, 48 and 52/follow-up ]

13.  Secondary:   Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline   [ Time Frame: Week 48 ]

14.  Secondary:   Corticosteroid Use Over Time   [ Time Frame: Weeks 8, 16, 24, 36 and 48 ]

15.  Secondary:   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   [ Time Frame: From baseline to Week 48 ]

16.  Secondary:   Observed Change From Baseline in Fecal Calprotectin by Week   [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]

17.  Secondary:   Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week   [ Time Frame: Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up ]

18.  Secondary:   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   [ Time Frame: Baseline and Week 48/early termination (ET) ]

19.  Secondary:   Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit   [ Time Frame: Baseline and Week 48/ET ]

20.  Secondary:   Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit   [ Time Frame: Week 48/ET ]

21.  Secondary:   Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category   [ Time Frame: Week 48/ET visit ]

22.  Secondary:   Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit   [ Time Frame: Baseline and Week 48/ET visit ]

23.  Secondary:   Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit   [ Time Frame: Baseline and Week 48/ET visit ]

24.  Secondary:   EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit   [ Time Frame: Baseline and Week 48/ET visit ]

25.  Secondary:   Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit   [ Time Frame: Baseline and Week 48/ET visit ]

26.  Secondary:   EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit   [ Time Frame: Baseline and Week 48/ET visit ]

27.  Secondary:   Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit   [ Time Frame: Baseline and Week 48/ET visit ]

28.  Secondary:   Percentage of Participants Hospitalized Due to Crohn’s Disease   [ Time Frame: From baseline to Week 52/follow-up ]

29.  Secondary:   Length of Hospitalizations Due to Crohn’s Disease   [ Time Frame: From baseline to Week 52/follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470599     History of Changes
Other Study ID Numbers: A3921086
2011-003622-27 ( EudraCT Number )
First Submitted: October 27, 2011
First Posted: November 11, 2011
Results First Submitted: June 20, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017