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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard clinical care | Active Comparator | Adalimumab induction as per standard clinical care:
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| Active optimization | Active Comparator | Same as Standard clinical care Arm, except:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Therapeutic drug monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waqqas Afif, MD, FRCPC | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary Medical Center (UCMC) | Calgary | Alberta | T2N 4Z6 | Canada | ||
| The University of British Columbia |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.
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 |
| Proportion of steroid free subjects | Steroid free defined as patients being steroid free at Week 12 | At Week 12 |
| 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 |
| Rates of complications | Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use. | 12 weeks |
| Vancouver |
| British Columbia |
| V6Z 1Y6 |
| Canada |
| London Health Sciences Centre (LHSC) University Hospital | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital, IBD Centre of Excellence | Ottawa | Ontario | K1H 8L6 | Canada |
| McGill University Hospital Center (MUHC) | Montreal | Quebec | H3G 1A4 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke (CHUS) | Sherbrooke | Quebec | J1G 2E8 | Canada |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |