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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01287897
First received: January 31, 2011
Last updated: October 28, 2014
Last verified: October 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: March 2015
Primary Completion Date: September 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
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: NCT01287897

  Show 212 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, 2010-023034-23, ANDANTE
Study First Received: January 31, 2011
Last Updated: October 28, 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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014