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| Name | Class |
|---|---|
| Agenzia Italiana del Farmaco | OTHER_GOV |
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Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA).
Each patient will be followed for 12 months.
All eligible subjects will be able to participate in the study at any infusion occurred after 12 months since the beginning. They will be screened by medical history, physical examination, blood and faecal tests (included C-reactive protein and faecal calprotectin), as required by clinical practice. No children, pregnant or breastfeeding women, or elder subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized and receive their first dose of study medication.
Subjects will be then evaluated every 8 weeks for the following 12 months from the randomization. Clinical and blood tests will be performed, and the partial Mayo Score will be calculated at each visit, until the final visit, when a new colonoscopy with biopsies will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal sample for calprotectin will be collected.
Safety of the study treatments will be evaluated at each study visit. In case of study agent discontinuation, the patient will be managed according to usual practice and followed for the entire study period. Patients randomized in AZA arm, could restart IFX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azathioprine | Experimental | Azathioprine 2-2.5 mg/kg/day, according to approved indication |
|
| Infliximab | Active Comparator | Infliximab 5 mg/kg every 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azathioprine | Drug | AZA treatment after IFX withdrawal for maintenance of remission |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | relapse rate in the two study groups. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse time | Mean time to relapse in the two groups | 12 months |
| Number of adverse events [Safety and Tolerability] | Number of adverse events of the two study strategies |
| Measure | Description | Time Frame |
|---|---|---|
| Direct costs [Pharmacokinetics] | Direct costs of the two treatment strategies | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvio Danese, MD, PhD | Contact | +390282245555 | IBDclinicaltrials@humanitas.it | |
| Gionata Fiorino, MD, PhD | Contact | +390282245555 | daniela.gilardi@humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBD Center | Recruiting | Rozzano | MI | 20089 | Italy |
| 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 |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001379 | Azathioprine |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
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Randomized parallel two-arm prospective open-label study
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| Infliximab |
| Drug |
IFX treatment for maintenance of remission |
|
| 12 months |
| Number of serious adverse events [Safety and Tolerability] | Number of serious adverse events of the two study strategies | 12 months |
| Identification of potential risk factors for relapse. Age, sex, smoking habits, histological healing of mucosa and each Mayo subscore at baseline will be examined | Potential risk factor for relapse will be evaluated by univariable analysis, and a multivariable analysis will be performed for all factors with p<0.30. Risk factors will be also analysed by logistic regression. Analysis of predetermined baseline characteristics (age, sex, smoking habits, histological healing of mucosa at baseline, and each Mayo subscore (stool number, presence of blood, colonic ulcerations) excluding the physician global assessment) to identify predictive factors for relapse. | 12 months |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| 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 |