PRADA

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

Brief summary

This is a multi-center study that explores the relationship between recapture of response with escalation to weekly active drug and trough concentration of the active drug before escalation in patients experiencing lack of response (LOR).

Observational study

Status:
Completed
Conditions:
Crohn's Disease
Enrollment:
98 patients
Protocol ID:
P15-770
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located