Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02896985
• Date of registration: 07/09/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific title: 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)
• Date of first enrolment: December 16, 2016
• Target sample size: 98
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02896985
• Study type: Observational

Countries of recruitment

Canada

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Primary Outcome(s)

Explore the relationship between drug concentration at baseline and recapture of response [Time Frame: At Week 12]

Secondary Outcome(s)

Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP) [Time Frame: From Week 0 to Week 12]

Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin [Time Frame: From Week 0 to Week 12]

Proportion of participants with clinical remission PRO2 < 8 [Time Frame: At Week 12]

Proportion of participants with 50% drop from screening in CRP or calprotectin [Time Frame: At Week 12]

Proportion of participants with normalization of CRP or fecal calprotectin [Time Frame: At Week 12]

Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations [Time Frame: At Week 12]

Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2) [Time Frame: From Week 0 to Week 12]

Proportion of participants requiring steroids or additional therapy [Time Frame: Up to Week 12]

Secondary ID(s)

P15-770

Source(s) of Monetary Support

Please refer to primary and secondary sponsors