TDM Guided Early Optimization of ADAL in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261102
• Other study ID #: MP-37-2017-2793
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Carolyne Lemieux, BN, RN
• Phone: (514) 934-1934
• Email: carolyne.lemieux[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Drug Monitoring
• Inflammatory Bowel Diseases

Intervention

Biological:
• Adalimumab

Locations

Country	Name	City	State
Canada	University of Calgary Medical Center (UCMC)	Calgary	Alberta
Canada	London Health Sciences Centre (LHSC) University Hospital	London	Ontario
Canada	McGill University Hospital Center (MUHC)	Montréal	Quebec
Canada	The Ottawa Hospital, IBD Centre of Excellence	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	The University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
waqqas.afif	AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Week 12
Secondary	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	From Week 0 to Week 12
Secondary	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)	At Week 8, 12
Secondary	Proportion of steroid free subjects	Steroid free defined as patients being steroid free at Week 12	At Week 12
Secondary	Subjects well-being	Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)	From Week 0 to Week 12
Secondary	Rates of complications	Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.	12 weeks