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Mucosal Healing Study in Crohn's Disease (CD)

NCT00297648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2011-08-31

Study results available
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Summary

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

Conditions

Interventions

BIOLOGICAL

Certolizumab pegol

Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-01-31
Completion
2009-12-31

Countries

  • Belgium
  • France
  • Germany

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 NCT00297648 on ClinicalTrials.gov