Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease
|ClinicalTrials.gov Identifier: NCT01817972|
Recruitment Status : Unknown
Verified March 2013 by Gastroenterology Research of America.
Recruitment status was: Not yet recruiting
First Posted : March 26, 2013
Last Update Posted : March 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Biological: Certolizumab pegol Drug: Azathioprine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||November 2014|
Placebo Comparator: Certolizumab pegol-Placebo Azathioprine
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.
Biological: Certolizumab pegol
Other Name: Cimzia
Active Comparator: Certolizumab pegol plus Azathioprine
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.
Biological: Certolizumab pegol
Other Name: CimziaDrug: Azathioprine
Other Name: Imuran, Azasan, generic Azathioprine
- Change in mean simple endoscopic scoring achieved by monotherapy versus combination therapy [ Time Frame: At the beginning of the study and at week 27 of the study ]The primary objective is to compare the change in mean SES-CD score achieved by combination therapy (Cimzia plus AZP) versus mono therapy (Cimzia alone). A colonoscopy will be performed at the beginning of the trial and at the conclusion of the treatment period to see if there were any changes between the two treatment groups.
- Assess differences in response rates and remission rates between the two groups [ Time Frame: At week 27 of the study which is their end of treatment study visit ]The secondary efficacy objective is to assess differences in response rates (which we will define for this trial as a drop to ≤10 on SES scoring)between the two groups.
- Assess differences in response rates and remission rates between the two groups [ Time Frame: At week 34 end of study ]The secondary efficacy objective is to assess differences in remission rates (no mucosal ulcerations at study end) between the two groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817972
|Contact: Carlo M Taboada, MDemail@example.com|
|Contact: Lauren K Reeves, BSfirstname.lastname@example.org|
|United States, Texas|
|Gastroenterology Research of America||Not yet recruiting|
|San Antonio, Texas, United States, 78229|
|Principal Investigator: Charles W Randall, MD|
|Sub-Investigator: Russell D Havranek, MD|
|Sub-Investigator: David L Stump, MD|
|Sub-Investigator: Christopher A Fincke, MD|
|Sub-Investigator: Franz Zurita, MD|
|Sub-Investigator: Gary S Gossen, MD|
|Principal Investigator:||Charles W Randall, MD||Gastroenterology Research of America|
|Study Director:||Carlo M Taboada, MD||Gastroenterology Research of America|