EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment (EUS)
|ClinicalTrials.gov Identifier: NCT01582568|
Recruitment Status : Terminated (Not enough subjects to reach accrual goals.)
First Posted : April 20, 2012
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohns Disease||Drug: Certolizumab||Phase 4|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment|
|Study Start Date :||June 2011|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Subjects will take the study drug certolizumab for 8 weeks. They will undergo a endoscopy before study drug and then again after study is complete. The study doctor will be looking for complete closure of the peri-anal fistula identified at visit 1 after the use of certolizumab based on and endoscopic ultrasound (EUS).
Certolizumab 200mg-400mg subcutaneous every 2 weeks for 8 weeks.
Other Name: Cimzia
- The response rate [ Time Frame: 6 months ]The primary objective of this study is to assess perianal and perirectal fistula healing (complete closure) based on endoscopic ultrasound (EUS) evaluation at 3 months and by PDAI (Pouchitis Disease Activity Index) and Fistula Drainage assessment by 6 months, showing no fistula (new or recurrence) on treatment of Certolizumab (Cimzia) in Crohn's's disease patient s.
- Fistula healing based on EUS [ Time Frame: 6 months ]The secondary objectives: 1. To define an Endoscopic Ultrasound (EUS)-based classification system which will compare and analyze perianal and perirectal fistulizing (abnormal opening between two hollow organs) in Crohn's disease. 2. To compare the EUS classification to PDAI and Fistula Drainage Assessment scores. 3. To determine EUS-based early predictors which can be summarized by the findings/results of the EUS procedure of fistula healing with Certolizumab (Cimzia) treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582568
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bincy P. Abraham, MD, MS||Baylor College of Medicine|