TDM Guided Early Optimization of ADAL in Crohn's Disease

March 31, 2023 updated by: waqqas.afif

Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study

To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Completed
        • University of Calgary Medical Center (UCMC)
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Completed
        • The University of British Columbia
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Completed
        • London Health Sciences Centre (LHSC) University Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Not yet recruiting
        • The Ottawa Hospital, IBD Centre of Excellence
        • Contact:
        • Principal Investigator:
          • Sanjay Murthy, MD
    • Quebec
      • Montréal, Quebec, Canada, H3G 1A4
        • Recruiting
        • McGill University Hospital Center (MUHC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Waqqas Afif, MD, FRCPC
        • Sub-Investigator:
          • Talat Bessissow, MDCM, FRCPC
        • Sub-Investigator:
          • Alain Bitton, MDCM, FRCPC
        • Sub-Investigator:
          • Che-yung Jeff Chao, MBChB, FRACP
        • Sub-Investigator:
          • Sophie Restellini-Kherad
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Recruiting
        • Centre hospitalier universitaire de Sherbrooke (CHUS)
        • Contact:
        • Principal Investigator:
          • Joannie Ruel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older.
  • Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
  • Active disease based on Harvey Bradshaw Index (HBI >5) and elevated C-reactive protein (CRP) (>normal reference range for local laboratory) OR fecal calprotectin (FCP) (>250 µg/g)
  • Due to commence treatment with ADAL.

Exclusion Criteria:

  • Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
  • History of active HIV, hepatitis B or C infection,
  • Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
  • Pregnancy
  • Prior exposure to ADAL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard clinical care

Adalimumab induction as per standard clinical care:

  • Week 0: 160 mg SC
  • Week 2: 80 mg SC
  • Followed by 40 mg SC every 2 weeks' maintenance therapy
Biological: Adalimumab
Other Names:
  • Humira
Active Comparator: Active optimization

Same as Standard clinical care Arm, except:

  • If ADAL trough ≤15 μg/ml, dose escalation with 80 mg SC at week 6 followed by 40 mg SC every week
  • If ADAL trough >15 μg/ml, no dose escalation and continued standard of care dosing
Biological: Adalimumab
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects who achieved remission
Time Frame: Week 12
Clinical remission will be scored by a Harvey-Bradshaw Index < 5 AND Biochemical remission will be scored by C-reactive protein < 5 mg/l OR Fecal calprotectin <250 μg/g (combination endpoint)
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects who achieved clinical response
Time Frame: From Week 0 to Week 12
Clinical response will be evaluated by a decreased in Harvey-Bradshaw Index score AND a decreased level of C-reactive protein OR Fecal calprotectin
From Week 0 to Week 12
Therapeutic drug monitoring
Time Frame: At Week 8, 12
Adalimumab drug concentration at week 8 and 12 AND proportion of subjects with antibody to Adalimumab at Week 8 and 12 on the rate i. Clinical response/remission (HBI<5) ii. Biochemical response/remission (CRP within normal reference range) iii. Endoscopic response (SES-CD reduction of ≥50% from baseline) / remission (SES-CD ≤3)
At Week 8, 12
Proportion of steroid free subjects
Time Frame: At Week 12
Steroid free defined as patients being steroid free at Week 12
At Week 12
Subjects well-being
Time Frame: From Week 0 to Week 12
Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)
From Week 0 to Week 12
Rates of complications
Time Frame: 12 weeks
Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

waqqas.afif

Collaborators

AbbVie

Investigators

  • Principal Investigator: Waqqas Afif, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-37-2017-2793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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