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

Would you like to know more about this trial?

Yes, please contact me

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

Calgary - T2N 4Z6
Edmonton - T6L 6K3
New Westminster - V3L 3W5
Vancouver - V6Z 2K5
Victoria - V8T 5G4
Victoria - V8V 3M9
Halifax - B3H 1V7
Cambridge - N1R 0B6
Hamilton - L8S 4K1
London - N6A 5A5
Oakville - L6M 4J2
Oshawa - L1H 7K4
Ottawa - K1H 8L6
Toronto - M5G 1X5
Windsor - N8W 1E6
Greenfield Park - J4V 2H1
Levis - G6V 3Z1
Montreal - H1T 2M4
Montreal - H3G 1A4
Montreal - H3P 3E5
Sherbrooke - J1G 2E8
Saskatoon - S7N 0W8
Fredericton - E3B 5N5
Winnipeg - R3A 1R9