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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01276509
First received: January 12, 2011
Last updated: April 13, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 (Opera)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate [ Time Frame: Week 8 and week 12 ]
    Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.


Secondary Outcome Measures:
  • Safety and Tolerability of PF‑00547659 Dose Levels Versus Placebo [ Time Frame: Week 0-12 ]
    Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.

  • Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo [ Time Frame: Week 0-12 ]
    Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.

  • Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission [ Time Frame: Weeks 8 and week 12 ]
    Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).

  • Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time [ Time Frame: Week 2, 4, 6, 8, 10 and 12 ]
    Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.

  • Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer [ Time Frame: Week 2, 4, 6, 8, 10 and 12 ]
    Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.

  • Immunogenicity Assessment of Anti-drug Antibodies (ADAs) [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36 ]
    Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659

  • The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) [ Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 ]
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.

  • The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) [ Time Frame: Day 1, 14, and 28 ]
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)

  • The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax) [ Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 ]
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.

  • The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax) [ Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 ]
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.

  • The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf) [ Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 ]
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.

  • The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F) [ Time Frame: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252 ]
    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.


Enrollment: 265
Actual Study Start Date: April 6, 2011
Study Completion Date: October 9, 2015
Primary Completion Date: February 7, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo-SC Injection
Placebo delivered SC, 3 doses separated by 4 weeks.
Drug: PF-00547659 SC injection
Placebo delivered SC, 3 doses separated by 4 weeks
Experimental: Drug Dose level 1- SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
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 dose level 2 delievered SC, 3 doses separated by 4 weeks.
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 dose level 3 delivered SC, 3 doses separated by 4 weeks.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01276509

  Show 137 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01276509     History of Changes
Other Study ID Numbers: A7281006
2010-023437-30 ( EudraCT Number )
OPERA ( Other Identifier: Alias Study Number )
Study First Received: January 12, 2011
Results First Received: October 5, 2016
Last Updated: April 13, 2017

Keywords provided by Shire:
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 25, 2017