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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)

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ClinicalTrials.gov Identifier: NCT02896985
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

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Study Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

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



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)



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896985


Contacts
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Contact: Nathalie Foucault +1 514-832-7702 nathalie.foucault@abbvie.com
Contact: Kevin McHugh +1 514-832-7438 kevin.mchugh@abbvie.com

Locations
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Canada, Alberta
University of Calgary /ID# 157893 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
South Edmonton Gastroenterolog /ID# 170934 Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Okanagan Clinical Trials /ID# 200046 Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Columbia Gastro Mgmnt Ltd /ID# 152507 Completed
New Westminster, British Columbia, Canada, V3L 3W5
GIRI Gastrointestinal Research Institute /ID# 201259 Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Discovery Clinical Services /ID# 154682 Recruiting
Victoria, British Columbia, Canada, V8T 5G4
Percuro Clinical Research, Ltd /ID# 202502 Recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Manitoba
Winnipeg Regional Health Autho /ID# 200115 Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, New Brunswick
Dr. Everett Chalmers Reg Hosp. /ID# 171560 Recruiting
Fredericton, New Brunswick, Canada, E3B 5N5
Canada, Nova Scotia
Qe Ii Hsc /Id# 152454 Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Dr. Mark Lee Medicine Professi /ID# 153127 Recruiting
Cambridge, Ontario, Canada, N1R 0B6
McMaster University Med Cent /ID# 151996 Recruiting
Hamilton, Ontario, Canada, L8S 4K1
London Health Sciences Centre /ID# 152508 Recruiting
London, Ontario, Canada, N6A 5A5
Jeffrey So Medicine Professional Corporation /ID# 168268 Recruiting
Oakville, Ontario, Canada, L6M 4J2
Taunton surgical centre /ID# 151998 Recruiting
Oshawa, Ontario, Canada, L1H 7K4
The Ottawa Hospital /ID# 153771 Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Mount Sinai Hosp.-Toronto /ID# 155262 Recruiting
Toronto, Ontario, Canada, M5G 1X5
Dr O Tarabain Medicine Prof Corp /ID# 163125 Recruiting
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
CISSS de la Monteregie /ID# 162724 Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Hotel-Dieu de Levis /ID# 155493 Completed
Levis, Quebec, Canada, G6V 3Z1
Hospital Maisonneuve-Rosemont /ID# 155184 Recruiting
Montreal, Quebec, Canada, H1T 2M4
McGill Univ HC /ID# 151997 Recruiting
Montreal, Quebec, Canada, H3G 1A4
Clinique MEDI-CLE /ID# 153772 Recruiting
Montreal, Quebec, Canada, H3P 3E5
CIUSSS de l'Estrie - CHUS /ID# 157976 Recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Canada, Saskatchewan
Royal Uni Saskatchew(CTSU) /ID# 162316 Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02896985     History of Changes
Other Study ID Numbers: P15-770
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents