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This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Crohn's disease | Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Explore the relationship between drug concentration at baseline and recapture of response | Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2) | Covariance analysis is used. | From Week 0 to Week 12 |
| Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be enrolled from approximately 15 to 20 investigative sites in Canada where such Therapeutic Drug Monitoring/Anti-Adalimumab Antibody (TDM/AAA) testing at the point of patient LOR and pre-dose escalation to Every Week (EW) occurs.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary /ID# 157893 | Calgary | Alberta | T2N 4Z6 | Canada | ||
| South Edmonton Gastroenterolog /ID# 170934 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42244850 | Derived | De Marco D, McHugh K, Plamondon S, Rioux LC, Steinhart AH, Horvat M, Afif W. An observational cohort study evaluating adalimumab concentrations for predicting non-recapture of biochemical response after dose escalation in patients with Crohn's disease experiencing secondary loss of response. J Can Assoc Gastroenterol. 2026 Feb 18;9(3):153-161. doi: 10.1093/jcag/gwag002. eCollection 2026 Jun. |
| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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Covariance analysis is used. |
| From Week 0 to Week 12 |
| Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin | Covariance analysis is used. | From Week 0 to Week 12 |
| Proportion of participants requiring steroids or additional therapy | Assessing participants that require steroids or additional therapy | Up to Week 12 |
| Proportion of participants with 50% drop from screening in CRP or calprotectin | Assessing participants with 50% drop in CRP or calprotectin. | At Week 12 |
| Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations | Covariance analysis is used. | At Week 12 |
| Proportion of participants with clinical remission PRO2 < 8 | PRO2 was developed based on FDA guidance for use of patient reported outcomes. | At Week 12 |
| Proportion of participants with normalization of CRP or fecal calprotectin | Assessing participants with normalization of CRP (<5mg/dl) or fecal calprotectin (<150ug/ml) | At Week 12 |
| Edmonton |
| Alberta |
| T6L 6K3 |
| Canada |
| Columbia Gastro Mgmnt Ltd /ID# 152507 | New Westminster | British Columbia | V3L 3W5 | Canada |
| GIRI Gastrointestinal Research Institute /ID# 201259 | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Discovery Clinical Services /ID# 154682 | Victoria | British Columbia | V8T 5G4 | Canada |
| Percuro Clinical Research, Ltd /ID# 202502 | Victoria | British Columbia | V8V 3M9 | Canada |
| Winnipeg Regional Health Autho /ID# 200115 | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Dr. Everett Chalmers Reg Hosp. /ID# 171560 | Fredericton | New Brunswick | E3B 5N5 | Canada |
| Qe Ii Hsc /Id# 152454 | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Dr. Mark Lee Medicine Professi /ID# 153127 | Cambridge | Ontario | N1R 0B6 | Canada |
| McMaster University Med Cent /ID# 151996 | Hamilton | Ontario | L8S 4K1 | Canada |
| London Health Sciences Centre /ID# 152508 | London | Ontario | N6A 5A5 | Canada |
| Jeffrey So Medicine Professional Corporation /ID# 168268 | Oakville | Ontario | L6M 4J2 | Canada |
| Taunton surgical centre /ID# 151998 | Oshawa | Ontario | L1H 7K4 | Canada |
| The Ottawa Hospital /ID# 153771 | Ottawa | Ontario | K1H 8L6 | Canada |
| Mount Sinai Hosp.-Toronto /ID# 155262 | Toronto | Ontario | M5G 1X5 | Canada |
| Dr O Tarabain Medicine Prof Corp /ID# 163125 | Windsor | Ontario | N8W 1E6 | Canada |
| CISSS de la Monteregie /ID# 162724 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hopital Hotel-Dieu de Levis /ID# 155493 | Lévis | Quebec | G6V 3Z1 | Canada |
| Hospital Maisonneuve-Rosemont /ID# 155184 | Montreal | Quebec | H1T 2M4 | Canada |
| McGill Univ HC /ID# 151997 | Montreal | Quebec | H3G 1A4 | Canada |
| Clinique MEDI-CLE /ID# 153772 | Montreal | Quebec | H3P 3E5 | Canada |
| CIUSSS de l'Estrie - CHUS /ID# 157976 | Sherbrooke | Quebec | J1G 2E8 | Canada |
| Royal Uni Saskatchew(CTSU) /ID# 162316 | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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