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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02896985

Collaborator

(none)

Enrollment

Locations

38.8

Actual Duration (Months)

4.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease

Study Design

Study Type:

Observational

Actual Enrollment :

98 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Dec 16, 2016

Actual Primary Completion Date :

Mar 11, 2020

Actual Study Completion Date :

Mar 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Participants with Crohn's disease Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment.

Outcome Measures

Primary Outcome Measures

Explore the relationship between drug concentration at baseline and recapture of response [At Week 12]
Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response.

Secondary Outcome Measures

Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2) [From Week 0 to Week 12]
Covariance analysis is used.
Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP) [From Week 0 to Week 12]
Covariance analysis is used.
Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin [From Week 0 to Week 12]
Covariance analysis is used.
Proportion of participants requiring steroids or additional therapy [Up to Week 12]
Assessing participants that require steroids or additional therapy
Proportion of participants with 50% drop from screening in CRP or calprotectin [At Week 12]
Assessing participants with 50% drop in CRP or calprotectin.
Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations [At Week 12]
Covariance analysis is used.
Proportion of participants with clinical remission PRO2 < 8 [At Week 12]
PRO2 was developed based on FDA guidance for use of patient reported outcomes.
Proportion of participants with normalization of CRP or fecal calprotectin [At Week 12]
Assessing participants with normalization of CRP (<5mg/dl) or fecal calprotectin (<150ug/ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary /ID# 157893	Calgary	Alberta	Canada	T2N 4Z6
2	South Edmonton Gastroenterolog /ID# 170934	Edmonton	Alberta	Canada	T6L 6K3
3	Columbia Gastro Mgmnt Ltd /ID# 152507	New Westminster	British Columbia	Canada	V3L 3W5
4	GIRI Gastrointestinal Research Institute /ID# 201259	Vancouver	British Columbia	Canada	V6Z 2K5
5	Discovery Clinical Services /ID# 154682	Victoria	British Columbia	Canada	V8T 5G4
6	Percuro Clinical Research, Ltd /ID# 202502	Victoria	British Columbia	Canada	V8V 3M9
7	Winnipeg Regional Health Autho /ID# 200115	Winnipeg	Manitoba	Canada	R3A 1R9
8	Dr. Everett Chalmers Reg Hosp. /ID# 171560	Fredericton	New Brunswick	Canada	E3B 5N5
9	Qe Ii Hsc /Id# 152454	Halifax	Nova Scotia	Canada	B3H 1V7
10	Dr. Mark Lee Medicine Professi /ID# 153127	Cambridge	Ontario	Canada	N1R 0B6
11	McMaster University Med Cent /ID# 151996	Hamilton	Ontario	Canada	L8S 4K1
12	London Health Sciences Centre /ID# 152508	London	Ontario	Canada	N6A 5A5
13	Jeffrey So Medicine Professional Corporation /ID# 168268	Oakville	Ontario	Canada	L6M 4J2
14	Taunton surgical centre /ID# 151998	Oshawa	Ontario	Canada	L1H 7K4
15	The Ottawa Hospital /ID# 153771	Ottawa	Ontario	Canada	K1H 8L6
16	Mount Sinai Hosp.-Toronto /ID# 155262	Toronto	Ontario	Canada	M5G 1X5
17	Dr O Tarabain Medicine Prof Corp /ID# 163125	Windsor	Ontario	Canada	N8W 1E6
18	CISSS de la Monteregie /ID# 162724	Greenfield Park	Quebec	Canada	J4V 2H1
19	Hopital Hotel-Dieu de Levis /ID# 155493	Levis	Quebec	Canada	G6V 3Z1
20	Hospital Maisonneuve-Rosemont /ID# 155184	Montreal	Quebec	Canada	H1T 2M4
21	McGill Univ HC /ID# 151997	Montreal	Quebec	Canada	H3G 1A4
22	Clinique MEDI-CLE /ID# 153772	Montreal	Quebec	Canada	H3P 3E5
23	CIUSSS de l'Estrie - CHUS /ID# 157976	Sherbrooke	Quebec	Canada	J1G 2E8
24	Royal Uni Saskatchew(CTSU) /ID# 162316	Saskatoon	Saskatchewan	Canada	S7N 0W8