TDM Guided Early Optimization of ADAL in Crohn's Disease

waqqas.afif

Status: Active, not recruiting

Conditions: Drug Monitoring; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Biological: Adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03261102

MP-37-2017-2793

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Standard clinical care

Active Comparator group

Description:

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

Treatment:

Biological: Adalimumab

Active optimization

Active Comparator group

Description:

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

Treatment:

Biological: Adalimumab