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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470599
First received: October 27, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratory abnormalities, and change from baseline in clinical laboratory values. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence of clinically significant changes in physical examination from baseline. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence of vital sign abnormalities and changes from baseline in vital sign measures. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measurements during treatment. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Summary of adjudicated cardiovascular endpoints (which will include number of subjects with confirmed diagnosis of angina, chronic heart failure, ischaemic heart disease, myocardial infarction, mortality, PAVD, stroke and transient Ischaemic attacks. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
  • Summary of malignancies confirmed by central laboratory pathologist over-read of biopsies. [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sustained clinical remission is defined as being in clinical remission at both Week 24 and Week 48. [ Time Frame: WEEKS 24 AND 48 ] [ Designated as safety issue: No ]
  • The proportion of all enrolled subjects in clinical remission and sustained clinical remission at Week 48. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The proportion of subjects in clinical remission and sustained clinical remission among subjects in clinical response (CDAI-100 response from Study A3921083 baseline) or clinical remission at A3921086 baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The median time to relapse among subjects in clinical remission at baseline. Relapse is defined as increase in CDAI of >100 points from the baseline and an absolute CDAI score of >220 points. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • CDAI scores over time and change from baseline in CDAI scores. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving a steroid-free clinical remission at Week 48 among subjects on steroids at baseline. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • Corticosteroid use over time. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]
  • Serum CRP and fecal calprotectin over time and change from baseline in CRP and fecal calprotectin. [ Time Frame: WEEK 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5mg BID Drug: CP-690,550
ORAL TABLET, 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:

  • Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
  • Women of childbearing potential must test negative for pregnancy prior to study enrolment.
  • Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion Criteria:

  • Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
  • Subjects who were discontinued from the A3921084 study due to an adverse event.
  • Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470599

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

  Show 93 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470599     History of Changes
Other Study ID Numbers: A3921086
Study First Received: October 27, 2011
Last Updated: July 8, 2014
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 July 29, 2014