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TNF-alpha inhibitor

Certolizumab pegol plus Azathioprine for Crohn's Disease

Phase 3
Waitlist Available
Led By Charles W Randall, MD
Research Sponsored by Gastroenterology Research of America
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 34 end of study
Awards & highlights

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.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 34 end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 34 end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mean simple endoscopic scoring achieved by monotherapy versus combination therapy
Secondary outcome measures
Assess differences in response rates and remission rates between the two groups

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Certolizumab pegol plus AzathioprineActive Control2 Interventions
Certolizumab pegol (Cimzia) 400mg Subcutaneous injection (per standard induction protocol) - which is at week 0, week 2, week4, week 6, then every 4 weeks until week 26. You will also be receiving Azathioprine tablets at a dosage of 1.5mg per kilogram of body weight once a day for 26 weeks. They will be 50mg tablets.
Group II: Certolizumab pegol-Placebo AzathioprinePlacebo Group1 Intervention
Certolizumab pegol (Cimzia) 400mg Subcutaneous injection (per standard induction protocol) - which is at week 0, week 2, week4, week 6, then every 4 weeks until week 26. You will also be receiving Azathioprine placebo tablets at a dosage of 1.5mg per kilogram of body weight once a day for 26 weeks. They will be 50mg tablets. This is not active Azathioprine.

Find a Location

Who is running the clinical trial?

Gastroenterology Research of AmericaLead Sponsor
UCB PharmaIndustry Sponsor
341 Previous Clinical Trials
109,276 Total Patients Enrolled
Charles W Randall, MDPrincipal InvestigatorGastroenterology Research of America

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease
2013. "Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01817972.
All > Crohns Disease
~5 spots leftby Apr 2025
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