NCT03261102Active, not recruiting
TDM Guided Early Optimization of ADAL in Crohn's Disease
Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
Source: ClinicalTrials.gov · Last updated 25 May 2025
Brief summary (registry, in English)
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 22 Aug 2017
- Start date
- 17 Jan 2017
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- waqqas.afif
- Diseases
- Crohn's disease
- NCT number
- NCT03261102
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 17 Jan 2017 to the primary completion date, 15 Jan 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to ADAL
Other illness
- 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.
Other
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary Medical Center (UCMC) Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| London Health Sciences Centre (LHSC) - University Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| McGill University Hospital Center (MUHC) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital, IBD Centre of Excellence Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Centre hospitalier universitaire de Sherbrooke (CHUS) Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| The University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.