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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

Tracking Information
First Submitted Date September 7, 2016
First Posted Date September 12, 2016
Last Update Posted Date March 22, 2019
Actual Study Start Date December 16, 2016
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02896985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 26, 2018)
  • 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.
  • 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.
  • 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.
  • Proportion of participants requiring steroids or additional therapy [ Time Frame: Up to Week 12 ]
    Assessing participants that require steroids or additional therapy
  • 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.
  • Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations [ Time Frame: At Week 12 ]
    Covariance analysis is used.
  • 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.
  • 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)
Original Secondary Outcome Measures
 (submitted: September 7, 2016)
  • 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 ]
    Linear regression analysis is used.
  • Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP) [ Time Frame: From Week 0 to Week 12 ]
    Linear regression analysis is used.
  • Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin [ Time Frame: From Week 0 to Week 12 ]
    Linear regression analysis is used.
  • Proportion of participants with clinical response [ Time Frame: At Week 12 ]
    It is defined as an 8 point drop in Patient Reported Outcome 2 (PRO2) with a 50% decrease in either C-Reactive Protein (CRP) or fecal calprotectin from screening and/or normalization of CRP (<5) or calprotectin (<100)
  • 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.
  • 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.
  • 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)
  • Proportion of participants requiring steroids or additional therapy [ Time Frame: Up to Week 12 ]
    Assessing participants that require steroids or additional therapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )
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)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Crohn's Disease
Intervention Not Provided
Study Groups/Cohorts Participants with Crohn's disease
Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 7, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nathalie Foucault +1 514-832-7702 nathalie.foucault@abbvie.com
Contact: Kevin McHugh +1 514-832-7438 kevin.mchugh@abbvie.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02896985
Other Study ID Numbers P15-770
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2019