Clinical trial NCT02896985: Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Patient Reported Outcome 2 (PRO 2)
C-Reactive Protein (CRP)
Adalimumab
Harvey Bradshaw Index (HBI)
Therapeutic Drug Monitoring (TDM)
Anti-Adalimumab Antibody (AAA)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-09-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled from approximately 15 to 20 investigative sites in Canada where such Therapeutic Drug Monitoring/Anti-Adalimumab Antibody (TDM/AAA) testing at the point of patient LOR and pre-dose escalation to Every Week (EW) occurs.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Explore the relationship between drug concentration at baseline and recapture of response
timeFrame: At Week 12
Secondary outcomes:
measure: Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)
timeFrame: From Week 0 to Week 12
measure: Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)
timeFrame: From Week 0 to Week 12
measure: Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin
timeFrame: From Week 0 to Week 12
measure: Proportion of participants requiring steroids or additional therapy
timeFrame: Up to Week 12
measure: Proportion of participants with 50% drop from screening in CRP or calprotectin
timeFrame: At Week 12
measure: Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations
timeFrame: At Week 12
measure: Proportion of participants with clinical remission PRO2 < 8
timeFrame: At Week 12
measure: Proportion of participants with normalization of CRP or fecal calprotectin
timeFrame: At Week 12
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary /ID# 157893
state: Alberta
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterolog /ID# 170934
state: Alberta
city: New Westminster
country: Canada
facility: Columbia Gastro Mgmnt Ltd /ID# 152507
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI Gastrointestinal Research Institute /ID# 201259
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services /ID# 154682
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 202502
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Autho /ID# 200115
state: Manitoba
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Reg Hosp. /ID# 171560
state: New Brunswick
city: Halifax
country: Canada
facility: Qe Ii Hsc /Id# 152454
state: Nova Scotia
city: Cambridge
country: Canada
facility: Dr. Mark Lee Medicine Professi /ID# 153127
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Med Cent /ID# 151996
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre /ID# 152508
state: Ontario
city: Oakville
country: Canada
facility: Jeffrey So Medicine Professional Corporation /ID# 168268
state: Ontario
city: Oshawa
country: Canada
facility: Taunton surgical centre /ID# 151998
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 153771
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hosp.-Toronto /ID# 155262
state: Ontario
city: Windsor
country: Canada
facility: Dr O Tarabain Medicine Prof Corp /ID# 163125
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie /ID# 162724
state: Quebec
city: Levis
country: Canada
facility: Hopital Hotel-Dieu de Levis /ID# 155493
state: Quebec
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont /ID# 155184
state: Quebec
city: Montreal
country: Canada
facility: McGill Univ HC /ID# 151997
state: Quebec
city: Montreal
country: Canada
facility: Clinique MEDI-CLE /ID# 153772
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 157976
state: Quebec
city: Saskatoon
country: Canada
facility: Royal Uni Saskatchew(CTSU) /ID# 162316
state: Saskatchewan
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: