Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases
Conditions
Keywords
IBD, Crohn, adalimumab, ADAL
Brief summary
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
Detailed 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.
Interventions
BIOLOGICALAdalimumab
Sponsors
AbbVie
waqqas.afif
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who achieved remission | Week 12 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who achieved clinical response | From Week 0 to Week 12 | Clinical response will be evaluated by a decreased in Harvey-Bradshaw Index score AND a decreased level of C-reactive protein OR Fecal calprotectin |
| Therapeutic drug monitoring | At Week 8, 12 | 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) |
| Proportion of steroid free subjects | At Week 12 | Steroid free defined as patients being steroid free at Week 12 |
| Subjects well-being | From Week 0 to Week 12 | Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ) |
| Rates of complications | 12 weeks | Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use. |
Countries
Canada
Outcome results
None listed