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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02896985
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : March 9, 2021
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
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

Resource links provided by the National Library of Medicine


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


Locations
Show Show 24 study locations
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    
Other Study ID Numbers: P15-770
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
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