Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease (OPERA)

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01276509
First received: January 12, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.


Condition Intervention Phase
Crohn's Disease
Drug: PF-00547659 SC injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-00547659 In Subjects With Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Crohn's Disease Activity Index (CDAI) 70 response rate at week 8 or week 12 (between the investigational product group and the placebo group). [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of PF-00547659 dose levels versus placebo: the frequency of treatment adverse events, withdrawal due to adverse events, and serious adverse events (SAEs) will be reported. [ Time Frame: 40 months ] [ Designated as safety issue: Yes ]
  • Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses Weeks 2 through 12. [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Immunogenicity assessments of antidrug antibodies (ADAs). [ Time Frame: 40 months ] [ Designated as safety issue: Yes ]
  • The PK of total PF-00547659 will be characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life will be estimated using data pooled from both typical and additional PK groups. [ Time Frame: 40 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: April 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo-SC Injection Drug: PF-00547659 SC injection
Placebo delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 1- SC injection Drug: PF-00547659 SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 2-SC injection Drug: PF-00547659 SC injection
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 3- SC injection Drug: PF-00547659 SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

  Eligibility

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

Inclusion Criteria:

  • Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
  • hsCRP greater than 3mg/L
  • Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria:

  • Pregnant or breast feeding
  • Short bowel syndrome due to multiple small bowel resections
  • Presence of a stoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276509

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

  Show 126 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: NCT01276509     History of Changes
Other Study ID Numbers: A7281006
Study First Received: January 12, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)

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

ClinicalTrials.gov processed this record on April 22, 2014