Crohn's Disease
Conditions
Keywords
Patient Reported Outcome 2 (PRO 2), C-Reactive Protein (CRP), Adalimumab, Harvey Bradshaw Index (HBI), Therapeutic Drug Monitoring (TDM), Anti-Adalimumab Antibody (AAA)
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).
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 changes in HBI between screening and final trough adalimumab concentrations | At Week 12 | Covariance analysis is used. |
| Proportion of participants with clinical remission PRO2 < 8 | At Week 12 | PRO2 was developed based on FDA guidance for use of patient reported outcomes. |
| 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 50% drop from screening in CRP or calprotectin | At Week 12 | Assessing participants with 50% drop in CRP or calprotectin. |
Countries
Canada
Outcome results
None listed