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Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease

NCT01817972 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2013-03-26

No results posted yet for this study

Summary

This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine) versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic Scoring in Crohn's Disease) score.

It is a trial where the investigators are administering biological therapy by itself and biological therapy plus an immunosuppressive medicine in combination to see which form of therapy has a better effect on healing ulcerations in the small intestine and colon that are due to a flare up of Crohn's disease.

Conditions

Interventions

BIOLOGICAL

Certolizumab pegol

Subcutaneous injection

DRUG

Azathioprine

50mg tablets

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Gastroenterology Research of America

    lead OTHER

Principal Investigators

  • Charles W Randall, MD · Gastroenterology Research of America

  • Carlo M Taboada, MD · Gastroenterology Research of America

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-06-30
Completion
2014-11-30

Countries

  • United States

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 NCT01817972 on ClinicalTrials.gov