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

NCT01276509 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2021-06-03

Study results available
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Summary

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.

Conditions

Interventions

DRUG

PF-00547659 SC injection

Placebo 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

DRUG

PF-00547659 SC injection

Drug dose level 2 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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-06
Primary Completion
2014-02-07
Completion
2015-10-09

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • France
  • Germany
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276509 on ClinicalTrials.gov