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| Name | Class |
|---|---|
| Janssen Inc. | INDUSTRY |
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The goal of this clinical trial is to evaluate whether disease remission can be maintained when biologic therapy is reduced in patients with Crohn"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST).
The main question it aims to answer is:
Can we de-escalate UST subcutaneous dose either from every 4 weeks (Q4) to every 8 weeks (Q8) or every 8 weeks (Q8) to every 12 weeks (Q12) in CD or UC patients in deep remission without loosing their response? Researchers will follow UST blood levels, inflammation markers and intestinal mucosa integrity and to see if UST dose can be reduced while maintaining clinical remission.
Participants will:
Change UST dosing from Q4 to Q8 or from Q8 to Q12. Visit the clinic once every 12 weeks for checkups and tests.
Participation in this research study will last 12 months and will include 4-6 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ustekinumab Q4w | Other |
| |
| Ustekinumab Q8w | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab 90 mg SC q8w | Biological | Sub-group switching from Q4w to Q8w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of clinical remission | Proportion of patients experiencing loss of remission | From treatment switch to end of participation (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-loss of Remission | From treatment switch to end of participation (12 months) | |
| Change from Baseline in the C-reactive protein (CRP) level at loss of remission. | To define if CRP level is a predictor of loss of remission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waqqas Afif, MD | Contact | 514-934-1943 | 36536 | waqqas.afif@mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUHC - Montreal General Hospital | Recruiting | Montreal | Quebec | H3G1A4 | Canada |
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| Ustekinumab 90 mg SC q12w |
| Biological |
Sub-group switching from Q8w to Q12w |
|
| 12 months |
| Change from Baseline in the calprotectin level at loss of remission. | To define if calprotectin level is a predictor of loss of remission. | 12 months |
| Disease duration before loss of remission. | Define if disease duration is a predictor of loss of remission. | Up to 50 years. |
| Change in drug concentration before loss of remission. | Define if drug concentration in blood is a predictor of loss of remission. | 12 months |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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