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)

• ClinicalTrials.gov Identifier: NCT02896985
• Recruitment Status: Completed
• First Posted: September 12, 2016
• Last Update Posted: March 9, 2021
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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).

Condition or disease
Crohn's Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 98 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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)
• Actual Study Start Date: December 16, 2016
• Actual Primary Completion Date: March 11, 2020
• Actual Study Completion Date: March 11, 2020

Groups and Cohorts

Group/Cohort
Participants with Crohn's disease; Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment.

Outcome Measures

Primary Outcome Measures :

1. Explore the relationship between drug concentration at baseline and recapture of response [ Time Frame: At Week 12 ]
   Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response.

Secondary Outcome Measures :

1. 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 ]
   Covariance analysis is used.
2. Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP) [ Time Frame: From Week 0 to Week 12 ]
   Covariance analysis is used.
3. Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin [ Time Frame: From Week 0 to Week 12 ]
   Covariance analysis is used.
4. Proportion of participants requiring steroids or additional therapy [ Time Frame: Up to Week 12 ]
   Assessing participants that require steroids or additional therapy
5. Proportion of participants with 50% drop from screening in CRP or calprotectin [ Time Frame: At Week 12 ]
   Assessing participants with 50% drop in CRP or calprotectin.
6. Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations [ Time Frame: At Week 12 ]
   Covariance analysis is used.
7. Proportion of participants with clinical remission PRO2 < 8 [ Time Frame: At Week 12 ]
   PRO2 was developed based on FDA guidance for use of patient reported outcomes.
8. Proportion of participants with normalization of CRP or fecal calprotectin [ Time Frame: At Week 12 ]
   Assessing participants with normalization of CRP (<5mg/dl) or fecal calprotectin (<150ug/ml)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from approximately 15 to 20 investigative sites in Canada where such Therapeutic Drug Monitoring/Anti-Adalimumab Antibody (TDM/AAA) testing at the point of patient LOR and pre-dose escalation to Every Week (EW) occurs.

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.

Contacts and Locations

Locations

Canada, Alberta

University of Calgary /ID# 157893

Calgary, Alberta, Canada, T2N 4Z6

South Edmonton Gastroenterolog /ID# 170934

Edmonton, Alberta, Canada, T6L 6K3

Canada, British Columbia

Columbia Gastro Mgmnt Ltd /ID# 152507

New Westminster, British Columbia, Canada, V3L 3W5

GIRI Gastrointestinal Research Institute /ID# 201259

Vancouver, British Columbia, Canada, V6Z 2K5

Discovery Clinical Services /ID# 154682

Victoria, British Columbia, Canada, V8T 5G4

Percuro Clinical Research, Ltd /ID# 202502

Victoria, British Columbia, Canada, V8V 3M9

Canada, Manitoba

Winnipeg Regional Health Autho /ID# 200115

Winnipeg, Manitoba, Canada, R3A 1R9

Canada, New Brunswick

Dr. Everett Chalmers Reg Hosp. /ID# 171560

Fredericton, New Brunswick, Canada, E3B 5N5

Canada, Nova Scotia

Qe Ii Hsc /Id# 152454

Halifax, Nova Scotia, Canada, B3H 1V7

Canada, Ontario

Dr. Mark Lee Medicine Professi /ID# 153127

Cambridge, Ontario, Canada, N1R 0B6

McMaster University Med Cent /ID# 151996

Hamilton, Ontario, Canada, L8S 4K1

London Health Sciences Centre /ID# 152508

London, Ontario, Canada, N6A 5A5

Jeffrey So Medicine Professional Corporation /ID# 168268

Oakville, Ontario, Canada, L6M 4J2

Taunton surgical centre /ID# 151998

Oshawa, Ontario, Canada, L1H 7K4

The Ottawa Hospital /ID# 153771

Ottawa, Ontario, Canada, K1H 8L6

Mount Sinai Hosp.-Toronto /ID# 155262

Toronto, Ontario, Canada, M5G 1X5

Dr O Tarabain Medicine Prof Corp /ID# 163125

Windsor, Ontario, Canada, N8W 1E6

Canada, Quebec

CISSS de la Monteregie /ID# 162724

Greenfield Park, Quebec, Canada, J4V 2H1

Hopital Hotel-Dieu de Levis /ID# 155493

Levis, Quebec, Canada, G6V 3Z1

Hospital Maisonneuve-Rosemont /ID# 155184

Montreal, Quebec, Canada, H1T 2M4

McGill Univ HC /ID# 151997

Montreal, Quebec, Canada, H3G 1A4

Clinique MEDI-CLE /ID# 153772

Montreal, Quebec, Canada, H3P 3E5

CIUSSS de l'Estrie - CHUS /ID# 157976

Sherbrooke, Quebec, Canada, J1G 2E8

Canada, Saskatchewan

Royal Uni Saskatchew(CTSU) /ID# 162316

Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

Additional Information:

clinical study report synopsis 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02896985
• Other Study ID Numbers: P15-770
• First Posted: September 12, 2016
• Last Update Posted: March 9, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:

Patient Reported Outcome 2 (PRO 2); C-Reactive Protein (CRP); Adalimumab; Harvey Bradshaw Index (HBI); Therapeutic Drug Monitoring (TDM); Anti-Adalimumab Antibody (AAA)

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases