TDM Guided Early Optimization of ADAL in Crohn's Disease

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: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Drug Monitoring
• Intervention / Treatment: Biological: Adalimumab

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 (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary Medical Center (UCMC)
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • The University of British Columbia
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre (LHSC) University Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital, IBD Centre of Excellence
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • McGill University Hospital Center (MUHC)
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Centre hospitalier universitaire de Sherbrooke (CHUS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	Steroid free defined as patients being steroid free at Week 12	At Week 12
Subjects well-being	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	Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.	12 weeks

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): January 15, 2025
• Study Completion (Estimated): June 1, 2025

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): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: IBD; adalimumab; Crohn; ADAL
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• 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
• product manufactured in and exported from the U.S.: No