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 August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470599
First received: October 27, 2011
Last updated: August 11, 2014
Last verified: August 2014

October 27, 2011
August 11, 2014
April 2012
June 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01470599 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
  • Drug: CP-690,550
    ORAL TABLET, TWICE DAILY
  • Drug: CP-690,550
    ORAL TABLETS, TWICE DAILY
  • Experimental: 5mg BID
    Intervention: Drug: CP-690,550
  • Experimental: 10mg BID
    Intervention: Drug: CP-690,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
July 2016
June 2016   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Australia,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   South Africa,   Spain,   Ukraine
 
NCT01470599
A3921086
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP