A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01287897
• Date of registration: 31/01/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy ANDANTE
• Scientific title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
• Date of first enrolment: February 2011
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01287897
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, New Zealand, Romania, Sweden, Switzerland, United Kingdom, 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

- hsCRP greater or equal to 5.0 mg/L

- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
within 8 weeks of study entry (screening) and able to retrospectively complete the
SES-CD or colonoscopy performed during screening

Exclusion Criteria:

- Pregnant or breastfeeding women

- Crohn's Disease with active fistulae or abscess

- History of diverticulitis or symptomatic diverticulosis

- Abnormality in hematology or chemistry profiles at screening



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

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: PF-04236921 SC injection

Primary Outcome(s)

The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg [Time Frame: Baseline and Week 8]

The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg [Time Frame: Baseline and Week 12]

The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg [Time Frame: Baseline and Week 12]

The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg [Time Frame: Baseline and Week 8]

Secondary Outcome(s)

Serum PF-04236921 Concentration Over Time [Time Frame: Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40]

Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg [Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12]

The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg [Time Frame: Baseline and Weeks 2, 4, 6, and 10]

The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg [Time Frame: Baseline and Weeks 2, 4, 6, and 10]

The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg [Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12]

Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg [Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12]

Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs) [Time Frame: Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)]

Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs) [Time Frame: At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40]

Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs) [Time Frame: At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40]

The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg [Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12]

The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg [Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12]

The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg [Time Frame: Baseline and Weeks 2, 4, 6, 8, 10, and 12]

Secondary ID(s)

B0151003

2010-023034-23

ANDANTE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01287897