Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )
PRADA
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)
1 other identifier
observational
98
1 country
24
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2016
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Start
First participant enrolled
December 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2020
CompletedMarch 9, 2021
March 1, 2021
3.2 years
September 7, 2016
March 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)
From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)
From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin
From Week 0 to Week 12
Proportion of participants requiring steroids or additional therapy
Up to Week 12
Proportion of participants with 50% drop from screening in CRP or calprotectin
At Week 12
- +3 more secondary outcomes
Study Arms (1)
Participants with Crohn's disease
Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (24)
University of Calgary /ID# 157893
Calgary, Alberta, T2N 4Z6, Canada
South Edmonton Gastroenterolog /ID# 170934
Edmonton, Alberta, T6L 6K3, Canada
Columbia Gastro Mgmnt Ltd /ID# 152507
New Westminster, British Columbia, V3L 3W5, Canada
GIRI Gastrointestinal Research Institute /ID# 201259
Vancouver, British Columbia, V6Z 2K5, Canada
Discovery Clinical Services /ID# 154682
Victoria, British Columbia, V8T 5G4, Canada
Percuro Clinical Research, Ltd /ID# 202502
Victoria, British Columbia, V8V 3M9, Canada
Winnipeg Regional Health Autho /ID# 200115
Winnipeg, Manitoba, R3A 1R9, Canada
Dr. Everett Chalmers Reg Hosp. /ID# 171560
Fredericton, New Brunswick, E3B 5N5, Canada
Qe Ii Hsc /Id# 152454
Halifax, Nova Scotia, B3H 1V7, Canada
Dr. Mark Lee Medicine Professi /ID# 153127
Cambridge, Ontario, N1R 0B6, Canada
McMaster University Med Cent /ID# 151996
Hamilton, Ontario, L8S 4K1, Canada
London Health Sciences Centre /ID# 152508
London, Ontario, N6A 5A5, Canada
Jeffrey So Medicine Professional Corporation /ID# 168268
Oakville, Ontario, L6M 4J2, Canada
Taunton surgical centre /ID# 151998
Oshawa, Ontario, L1H 7K4, Canada
The Ottawa Hospital /ID# 153771
Ottawa, Ontario, K1H 8L6, Canada
Mount Sinai Hosp.-Toronto /ID# 155262
Toronto, Ontario, M5G 1X5, Canada
Dr O Tarabain Medicine Prof Corp /ID# 163125
Windsor, Ontario, N8W 1E6, Canada
CISSS de la Monteregie /ID# 162724
Greenfield Park, Quebec, J4V 2H1, Canada
Hopital Hotel-Dieu de Levis /ID# 155493
Lévis, Quebec, G6V 3Z1, Canada
Hospital Maisonneuve-Rosemont /ID# 155184
Montreal, Quebec, H1T 2M4, Canada
McGill Univ HC /ID# 151997
Montreal, Quebec, H3G 1A4, Canada
Clinique MEDI-CLE /ID# 153772
Montreal, Quebec, H3P 3E5, Canada
CIUSSS de l'Estrie - CHUS /ID# 157976
Sherbrooke, Quebec, J1G 2E8, Canada
Royal Uni Saskatchew(CTSU) /ID# 162316
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
September 12, 2016
Study Start
December 16, 2016
Primary Completion
March 11, 2020
Study Completion
March 11, 2020
Last Updated
March 9, 2021
Record last verified: 2021-03