TDM Guided Early Optimization of ADAL in Crohn's Disease

N/AActive Not RecruitingNCT03261102

waqqas.afif200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Crohn Disease Drug Monitoring Inflammatory Bowel Diseases

Interventions

AdalimumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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)

Time frame: Week 12

Secondary Outcomes

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

Time frame: 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)

Time frame: At Week 8, 12

Proportion of steroid free subjects

Steroid free defined as patients being steroid free at Week 12

Time frame: At Week 12

Subjects well-being

Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)

Time frame: From Week 0 to Week 12

Rates of complications

Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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