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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00940-49 | Other Identifier | ID-RCB number, ANSM |
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Not enough recruitment Lack of funding CR
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This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimisation strategy | Other | increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks |
|
| Addition strategy | Other | same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab 10mg/kg every 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in Clinical remission | the clinical remission is defined by Harvey Bradshaw (HBI) Index < 4 for Crohn's disease or Simple Clinical Colitis Activity Index (SCCAI)<4 for ulcerative colitis. | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in deep remission | clinical remission associated with endoscopic remission (CDEIS <3 for CD patients or Mayo score<2 for UC patients) | At Week 52 |
| Number of patient in remission and clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Pariente, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Hôpital Claude Huriez | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40013523 | Derived | Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D015122 | Mercaptopurine |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Mercaptopurine |
| Drug |
6-mercaptopurine 1 à 1,5 mg/kg |
|
|
| Azathioprine | Drug | Azathioprine 2 à 2.5mg/kg/j |
|
|
| Infliximab | Drug | Infliximab 5mg/kg every 8 weeks |
|
clinical response is defined as a decrease of at least 3 points of HBI for CD patients or SCCAI for UC patients compared to baseline (week 0).
Simple Clinical Colitis Activity Index (SCCAI)<4 for ulcerative colitisHBI pour MC et SCCAI pour RCH <4 associated at CRP < 5 mg/dl.
| At week 16 |
| infliximab blood concentration | Baseline, week 16 ad week 52 |
| infliximab antibodies concentration | Baseline, week 16 ad week 52 |
| economic criteria | medical fees in each arm | At week 52 |
| number of patient with adverse effects and allergic reactions with infliximab | At week 52 |
| Inflammatory bowel disease questionnaire (score IBDQ) | quality of life | Baseline and week 52 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| 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 |
| D013872 | Thionucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |