TDM Guided Early Optimization of ADAL in Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 10 April 2023
• Main ID: NCT03261102
• Date of registration: 22/08/2017
• Prospective Registration: No
• Primary sponsor: waqqas.afif
• Public title: TDM Guided Early Optimization of ADAL in Crohn's Disease
• Scientific title: Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
• Date of first enrolment: January 17, 2017
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03261102
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Waqqas Afif, MD, FRCPC
• Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

• Name: Carolyne Lemieux, BN, RN

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Drug Monitoring

Crohn Disease

Inflammatory Bowel Diseases

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Proportion of subjects who achieved remission [Time Frame: Week 12]

Secondary Outcome(s)

Proportion of steroid free subjects [Time Frame: At Week 12]

Rates of complications [Time Frame: 12 weeks]

Subjects well-being [Time Frame: From Week 0 to Week 12]

Proportion of subjects who achieved clinical response [Time Frame: From Week 0 to Week 12]

Therapeutic drug monitoring [Time Frame: At Week 8, 12]

Secondary ID(s)

MP-37-2017-2793

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AbbVie