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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence.
Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks.
Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks.
The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental |
| |
| 6-mercaptopurine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Subcutaneous adalimumab injections, loading dose of 160 mg and 80 mg on 0 and 2 weeks and maintenance of 40 mg every other week for the duration of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with endoscopic recurrence at 12 months, as evaluated by the Rutgeerts endoscopic scoring system. | Primay outcome measure will assess the efficacy of adalimumab, compared to immunomodulator therapy in maintaining mucosal healing after 52 weeks (1 year). | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in clinical remission at 12 months as assessed by the CDAI score. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erez F Scapa, M.D. | Contact | 972-52-4266345 | erezs@tasmc.health.gov.il | |
| Sara Pel, MPH | Contact | 972-3-6973011 | sarap@tasmc.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Erez F Scapa, M.D. | Tel-Aviv Sourasky Medical Center, Affiliated to Tel-Aviv University | Principal Investigator |
| Iris Dotan, M.D. | Tel-Aviv Sourasky Medical Center, Affiliated to Tel-Aviv University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Liver Diseases, Tel-Aviv Soursky Medical Center | Tel Aviv | 64239 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19109962 | Background | Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31. | |
| 38137669 | Derived | Hirsch A, Scapa E, Fliss-Isakov N, Tulchinsky H, Itzkowitz E, Kariv Y, Ron Y, Yanai H, White I, Yassin S, Cohen NA, Brazovski E, Dotan I, Maharshak N. Early Initiation of Adalimumab Significantly Diminishes Postoperative Crohn's Disease Endoscopic Recurrence and Is Superior to 6-Mercaptopurine Therapy: An Open-Label, Randomized Controlled Study. J Clin Med. 2023 Dec 10;12(24):7600. doi: 10.3390/jcm12247600. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D015122 | Mercaptopurine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| 6 Mercaptopurine | Drug | 6MP will be administered orally starting at a dose of 6MP of 50mg/day with escalating doses every 1-2 weeks as tolerated, to a target dose of 1-1.5 mg/kg. -------------------------------------------------------------------------------- |
|
|
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |