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

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01287897
First received: January 31, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.


Condition Intervention Phase
Crohn's Disease
Drug: PF-04236921 SC injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The Crohn's Disease Activity Index (CDAI) 70 response rate at Week 8 or Week 12 [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses [ Time Frame: Weeks 2 through 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline for CDAI score [ Time Frame: Weeks 2 through 12 ] [ Designated as safety issue: No ]
  • Percent of subjects that develop anti drug antibodies (ADAs) and neutralizing antibodies (NAbs), if observed [ Time Frame: baseline, and Weeks 4, 8, 12, 16, 24, 32 and 40 ] [ Designated as safety issue: Yes ]
  • Serum concentrations of PF 04236921 [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10 and Week 12 and monthly through Week 40 ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo- SC injection Drug: PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks
Experimental: Drug Dose level 1 - SC injection Drug: PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
Experimental: Drug Dose level 2 - SC injection Drug: PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287897

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

  Show 182 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: NCT01287897     History of Changes
Other Study ID Numbers: B0151003
Study First Received: January 31, 2011
Last Updated: April 1, 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 17, 2014