TDM Guided Early Optimization of ADAL in Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-17

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Crohn Disease Drug Monitoring Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type BIOLOGICAL

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

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type BIOLOGICAL

Interventions

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Adalimumab

Intervention Type BIOLOGICAL

Other Intervention Names

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Humira

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No