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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.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: October 27, 2011
Last updated: February 22, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Incidence and severity of clinical laboratory abnormalities, and change from baseline in clinical laboratory values. [ Time Frame: 52 WEEKS ]
  • Incidence of clinically significant changes in physical examination from baseline. [ Time Frame: 52 WEEKS ]
  • Incidence of vital sign abnormalities and changes from baseline in vital sign measures. [ Time Frame: 52 WEEKS ]
  • Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measurements during treatment. [ Time Frame: 52 WEEKS ]
  • 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 ]
  • Summary of malignancies confirmed by central laboratory pathologist over-read of biopsies. [ Time Frame: 52 WEEKS ]

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 ]
  • The proportion of all enrolled subjects in clinical remission and sustained clinical remission at Week 48. [ Time Frame: WEEK 48 ]
  • The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline. [ Time Frame: WEEK 48 ]
  • 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 ]
  • 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 ]
  • CDAI scores over time and change from baseline in CDAI scores. [ Time Frame: WEEK 48 ]
  • The proportion of subjects achieving a steroid-free clinical remission at Week 48 among subjects on steroids at baseline. [ Time Frame: WEEK 48 ]
  • Corticosteroid use over time. [ Time Frame: WEEK 48 ]
  • Serum CRP and fecal calprotectin over time and change from baseline in CRP and fecal calprotectin. [ Time Frame: WEEK 48 ]

Enrollment: 150
Study Start Date: April 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5mg BID Drug: CP-690,550
Experimental: 10mg BID Drug: CP-690,550


Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01470599

  Show 75 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01470599     History of Changes
Other Study ID Numbers: A3921086
2011-003622-27 ( EudraCT Number )
Study First Received: October 27, 2011
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017