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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01276509
• Date of registration: 12/01/2011
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease OPERA
• Scientific 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)
• Date of first enrolment: April 6, 2011
• Target sample size: 265
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01276509
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, South Africa, Spain, Sweden, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: PF-00547659 SC injection

Primary Outcome(s)

Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate [Time Frame: Week 8 and week 12]

Secondary Outcome(s)

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 - 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]

Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo [Time Frame: Week 0-12]

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]

Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time [Time Frame: Week 2, 4, 6, 8, 10 and 12]

Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer [Time Frame: Week 2, 4, 6, 8, 10 and 12]

Immunogenicity Assessment of Anti-drug Antibodies (ADAs) [Time Frame: Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36]

Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission [Time Frame: Weeks 8 and week 12]

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]

Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo [Time Frame: Week 0-12]

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 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau) [Time Frame: Day 1, 14, and 28]

Secondary ID(s)

OPERA

2010-023437-30

A7281006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01276509