Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
Overview
- Phase
- Not Applicable
- Intervention
- Adalimumab
- Conditions
- Crohn Disease
- Sponsor
- waqqas.afif
- Enrollment
- 200
- Locations
- 6
- Primary Endpoint
- Proportion of subjects who achieved remission
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with 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.
Investigators
waqqas.afif
Dr. Waqqas Afif MD, FRCPC
McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Adalimumab
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
Intervention: Adalimumab
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Proportion of steroid free subjects(At Week 12)
- Rates of complications(12 weeks)
- Proportion of subjects who achieved clinical response(From Week 0 to Week 12)
- Subjects well-being(From Week 0 to Week 12)
- Therapeutic drug monitoring(At Week 8, 12)