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).
Study Type
OBSERVATIONAL
Enrollment
98
University of Calgary /ID# 157893
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.
Time frame: At Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)
Covariance analysis is used.
Time frame: From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)
Covariance analysis is used.
Time frame: From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin
Covariance analysis is used.
Time frame: From Week 0 to Week 12
Proportion of participants requiring steroids or additional therapy
Assessing participants that require steroids or additional therapy
Time frame: Up to Week 12
Proportion of participants with 50% drop from screening in CRP or calprotectin
Assessing participants with 50% drop in CRP or calprotectin.
Time frame: At Week 12
Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations
Covariance analysis is used.
Time frame: At Week 12
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Calgary, Alberta, Canada
South Edmonton Gastroenterolog /ID# 170934
Edmonton, Alberta, Canada
Columbia Gastro Mgmnt Ltd /ID# 152507
New Westminster, British Columbia, 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
Winnipeg Regional Health Autho /ID# 200115
Winnipeg, Manitoba, Canada
Dr. Everett Chalmers Reg Hosp. /ID# 171560
Fredericton, New Brunswick, Canada
Qe Ii Hsc /Id# 152454
Halifax, Nova Scotia, Canada
Dr. Mark Lee Medicine Professi /ID# 153127
Cambridge, Ontario, Canada
...and 14 more locations
Proportion of participants with clinical remission PRO2 < 8
PRO2 was developed based on FDA guidance for use of patient reported outcomes.
Time frame: At Week 12
Proportion of participants with normalization of CRP or fecal calprotectin
Assessing participants with normalization of CRP (\<5mg/dl) or fecal calprotectin (\<150ug/ml)
Time frame: At Week 12