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A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01393626
First received: July 11, 2011
Last updated: June 10, 2013
Last verified: June 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Crohn's Disease
 Drug: Placebo
Drug: CP-690,550
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects in clinical remission at week 8 as defined by a Crohn's disease activity index (CDAI) score of less than 150 points. [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportions of subjects in clinical remission (CDAI<150) at Week 2 and 4. [ Time Frame: week 2 and 4 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving clinical response-70 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 70 points from baseline. [ Time Frame: week 2, 4 and 8 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving clinical response-100 at Week 2, 4, and 8 as defined by a decrease in CDAI score of at least 100 points from baseline. [ Time Frame: week 2, 4 and 8 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving either clinical response-100 or clinical remission (CDAI<150) at Week 2, 4, and 8. [ Time Frame: week 2, 4 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo BID Drug: Placebo
oral tablets twice daily
Experimental: 5mg BID Drug: CP-690,550
oral tablets twice daily
Experimental: 10mg BID Drug: CP-690,550
oral tablets twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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-TNFα 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393626

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 77 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01393626     History of Changes
Other Study ID Numbers: A3921083
Study First Received: July 11, 2011
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013