Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )

Crohn's Disease Clinical Trial

— PRADA  

Official title:

A Cohort Study to Evaluate the Effectiveness of Drug Concentrations in Predicting Recapture of Response With Weekly ADAlimumab in Crohn's Disease Subjects With Secondary Loss of Response (PRADA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896985
• Other study ID #: P15-770
• Status: Completed
• Start date: December 16, 2016
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of Crohn's Disease.

• Treatment with adalimumab, for a minimum of 16 weeks, as per clinical practice, at a dose of 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w with a documented response as defined by the investigator.

• Current evidence of active inflammatory disease/LOR defined as the presence of active inflammation (confirmed with a CRP = 5 mg/L and/or a fecal calprotectin = 250µg/g.

• Ability of subject to participate fully in all aspects of this clinical trial.

• Written informed consent must be obtained and documented.

Exclusion Criteria:

• Primary non-responders to 16 weeks of adalimumab therapy.

• Received any investigational drug within the 16 weeks of adalimumab therapy.

• Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.

• History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.

• Stools positive for Clostridium difficile.

• Pregnant or lactating women.

• Current enrolment in any other interventional research study.

• Presence of perianal or abdominal abscess.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
Canada	University of Calgary /ID# 157893	Calgary	Alberta
Canada	Dr. Mark Lee Medicine Professi /ID# 153127	Cambridge	Ontario
Canada	South Edmonton Gastroenterolog /ID# 170934	Edmonton	Alberta
Canada	Dr. Everett Chalmers Reg Hosp. /ID# 171560	Fredericton	New Brunswick
Canada	CISSS de la Monteregie /ID# 162724	Greenfield Park	Quebec
Canada	Qe Ii Hsc /Id# 152454	Halifax	Nova Scotia
Canada	McMaster University Med Cent /ID# 151996	Hamilton	Ontario
Canada	Hopital Hotel-Dieu de Levis /ID# 155493	Levis	Quebec
Canada	London Health Sciences Centre /ID# 152508	London	Ontario
Canada	Clinique MEDI-CLE /ID# 153772	Montreal	Quebec
Canada	Hospital Maisonneuve-Rosemont /ID# 155184	Montreal	Quebec
Canada	McGill Univ HC /ID# 151997	Montreal	Quebec
Canada	Columbia Gastro Mgmnt Ltd /ID# 152507	New Westminster	British Columbia
Canada	Jeffrey So Medicine Professional Corporation /ID# 168268	Oakville	Ontario
Canada	Taunton surgical centre /ID# 151998	Oshawa	Ontario
Canada	The Ottawa Hospital /ID# 153771	Ottawa	Ontario
Canada	Royal Uni Saskatchew(CTSU) /ID# 162316	Saskatoon	Saskatchewan
Canada	CIUSSS de l'Estrie - CHUS /ID# 157976	Sherbrooke	Quebec
Canada	Mount Sinai Hosp.-Toronto /ID# 155262	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 201259	Vancouver	British Columbia
Canada	Discovery Clinical Services /ID# 154682	Victoria	British Columbia
Canada	Percuro Clinical Research, Ltd /ID# 202502	Victoria	British Columbia
Canada	Dr O Tarabain Medicine Prof Corp /ID# 163125	Windsor	Ontario
Canada	Winnipeg Regional Health Autho /ID# 200115	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explore the relationship between drug concentration at baseline and recapture of response	Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response.	At Week 12
Secondary	Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)	Covariance analysis is used.	From Week 0 to Week 12
Secondary	Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)	Covariance analysis is used.	From Week 0 to Week 12
Secondary	Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin	Covariance analysis is used.	From Week 0 to Week 12
Secondary	Proportion of participants requiring steroids or additional therapy	Assessing participants that require steroids or additional therapy	Up to Week 12
Secondary	Proportion of participants with 50% drop from screening in CRP or calprotectin	Assessing participants with 50% drop in CRP or calprotectin.	At Week 12
Secondary	Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations	Covariance analysis is used.	At Week 12
Secondary	Proportion of participants with clinical remission PRO2 < 8	PRO2 was developed based on FDA guidance for use of patient reported outcomes.	At Week 12
Secondary	Proportion of participants with normalization of CRP or fecal calprotectin	Assessing participants with normalization of CRP (<5mg/dl) or fecal calprotectin (<150ug/ml)	At Week 12

External Links

•   clinical study report synopsis