TDM Guided Early Optimization of ADAL in Crohn's Disease

NCT03261102 — Not applicable, Active not recruiting, 200 participants, waqqas.afif

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

Registry	NCT03261102
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	200 (Estimated)
Sponsor	waqqas.afif (Other); collaborators: AbbVie
Conditions	Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases
Interventions	Adalimumab (Biological)
Dates	start 2017-01-17, primary completion 2025-01-15, completion 2025-06-01 (estimated), first posted 2017-08-24, last updated 2025-05-25
Locations	6 sites in Canada

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard clinical care	Active comparator	Biological: Adalimumab	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
Active optimization	Active comparator	Biological: Adalimumab	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

Adalimumab (Biological), also known as Humira

+Outcome measures

Primary outcomes

Proportion of subjects who achieved remission [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)

Secondary outcomes

Proportion of subjects who achieved clinical response [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
Therapeutic drug monitoring [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)
Proportion of steroid free subjects [At Week 12]: Steroid free defined as patients being steroid free at Week 12
Subjects well-being [From Week 0 to Week 12]: Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)
Rates of complications [12 weeks]: Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (6)

Facility	City	Country
University of Calgary Medical Center (UCMC)	Calgary, Alberta	Canada
The University of British Columbia	Vancouver, British Columbia	Canada
London Health Sciences Centre (LHSC) University Hospital	London, Ontario	Canada
The Ottawa Hospital, IBD Centre of Excellence	Ottawa, Ontario	Canada
McGill University Hospital Center (MUHC)	Montreal, Quebec	Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke, Quebec	Canada

+Investigators

Waqqas Afif, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

My Notes

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