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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 May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01276509
First received: January 12, 2011
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

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

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: April 2016
Estimated Primary Completion Date: April 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 121 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: NCT01276509     History of Changes
Other Study ID Numbers: A7281006
Study First Received: January 12, 2011
Last Updated: May 15, 2013
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 May 22, 2013