Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )
- Conditions
- Crohn's Disease
- Registration Number
- NCT02896985
- Lead Sponsor
- AbbVie
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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)
Proportion of participants with clinical remission PRO2 < 8 At Week 12 PRO2 was developed based on FDA guidance for use of patient reported outcomes.
Trial Locations
- Locations (24)
Columbia Gastro Mgmnt Ltd /ID# 152507
🇨🇦New Westminster, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 201259
🇨🇦Vancouver, British Columbia, Canada
Percuro Clinical Research, Ltd /ID# 202502
🇨🇦Victoria, British Columbia, Canada
Dr. Everett Chalmers Reg Hosp. /ID# 171560
🇨🇦Fredericton, New Brunswick, Canada
Discovery Clinical Services /ID# 154682
🇨🇦Victoria, British Columbia, Canada
University of Calgary /ID# 157893
🇨🇦Calgary, Alberta, Canada
South Edmonton Gastroenterolog /ID# 170934
🇨🇦Edmonton, Alberta, Canada
Dr. Mark Lee Medicine Professi /ID# 153127
🇨🇦Cambridge, Ontario, Canada
Qe Ii Hsc /Id# 152454
🇨🇦Halifax, Nova Scotia, Canada
McMaster University Med Cent /ID# 151996
🇨🇦Hamilton, Ontario, Canada
The Ottawa Hospital /ID# 153771
🇨🇦Ottawa, Ontario, Canada
London Health Sciences Centre /ID# 152508
🇨🇦London, Ontario, Canada
Taunton surgical centre /ID# 151998
🇨🇦Oshawa, Ontario, Canada
Jeffrey So Medicine Professional Corporation /ID# 168268
🇨🇦Oakville, Ontario, Canada
CISSS de la Monteregie /ID# 162724
🇨🇦Greenfield Park, Quebec, Canada
Mount Sinai Hosp.-Toronto /ID# 155262
🇨🇦Toronto, Ontario, Canada
Dr O Tarabain Medicine Prof Corp /ID# 163125
🇨🇦Windsor, Ontario, Canada
McGill Univ HC /ID# 151997
🇨🇦Montreal, Quebec, Canada
Clinique MEDI-CLE /ID# 153772
🇨🇦Montreal, Quebec, Canada
Royal Uni Saskatchew(CTSU) /ID# 162316
🇨🇦Saskatoon, Saskatchewan, Canada
Hopital Hotel-Dieu de Levis /ID# 155493
🇨🇦Levis, Quebec, Canada
Hospital Maisonneuve-Rosemont /ID# 155184
🇨🇦Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 157976
🇨🇦Sherbrooke, Quebec, Canada
Winnipeg Regional Health Autho /ID# 200115
🇨🇦Winnipeg, Manitoba, Canada