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Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )
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).
The relationship between the observation period and the time of patient enrollment. Time perspective can be prospective: looking forward using periodic observations usually collected following patient enrollment, or retrospective: looking back using observations usually collected prior to patient selection and enrollment.
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.
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.
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