Ulcerative Colitis MedDRA version: 15.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: AZAFOR 50mg
Product Name: AZATIOPRINA
Product Code: AZA
Pharmaceutical Form: Tablet
INN or Proposed INN: AZATHIOPRINE
CAS Number: 446-86-6
Current Sponsor code: AZA
Other descriptive name:
Sponsors
Dipartimento di Pediatria Università Federico II di Napoli
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children 2-17 years of age. 2. New diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histological criteria. 3. Moderate to severe disease activity at the time of enrolment as judged by a Pediatric UC Activity Index (PUCAI) score = 35 points. 4. In general good health (other than the diagnosis of UC), based on medical history, physical examination, and screening laboratory results. 5. Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent. Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability or unwillingness to give informed consent. 2. Weight 1.5 times the upper limit of the age appropriate normal. 10. Existence of current hepatic disease, or ALT, AST, Bilirubin > 2 times the upper limit of normal, or the existence of Primary Sclerosing Cholangitis (PSC). 11. History of recurrent pancreatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether the addition of azathioprine to a standard therapeutic regimen (mesalazine and steroid association) improves disease remission rates in children affected by newly diagnosed moderate-to-severe Ulcerative Colitis, during the first eighteen months of treatment.;Secondary Objective: 1)To assess the efficacy of the azathioprine, mesalazine and steroid association versus the steroid and mesalazine standard therapy on the induction of remission, on the maintenance of remission at eighteen months of follow-up. 2) To compare time to steroid independence in each of the study groups, as defined in the paragraph Intervention. 3) To evaluate and compare the quality of the life with the two therapeutic strategies. 4) To assess the safety and tolerability of the azathioprine, mesalazine and steroid association in children.;Primary end point(s): Proportion of patients who is in clinical remission at eighteen months. Clinical remission will be defined on the basis of a PUCAI score =10, without any clinical relapse or treatment failures during the first eighteen months. Clinical relapse will be defined as the occurrence or worsening of symptoms, accompanied by an increase of PUCAI >10 points, sufficient to require rescue treatment with IV corticosteroids, other immunosuppressive agents, as IV cyclosporine, anti-TNF ; or surgery. The following events will also be considered as treatment failures: • Subject experiences a serious adverse event • Patient fails to comply with this study protocol • WBC 10-fold greater than normal value • Pregnancy;Timepoint(s) of evaluation of this end point: During the first eighteen months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Reduction in total oral CS usage 2) Mean change in PUCAI score during follow up 3)Time to achieve first remission (PUCAI<10) comparing the two groups 4) Incidence of adverse events 5) Compliance between groups judged by returning of packages and self reporting 6) Percentage of relapses and treatment failures comparing the two groups 7) Mean change in IMPACT III score at 3, 6, 9, 12 months;Timepoint(s) of evaluation of this end point: 1) Reduction in total oral CS usage: from 0 to 4 weeks and from 4 to 12 weeks 2) Mean change in PUCAI score during follow up: During the first eighteen months 3)Time to achieve first remission (PUCAI<10) comparing the two groups: During the first eighteen months 4) Incidence of adverse events: During the first eighteen months 5) Compliance between groups judged by returning of packages and self reporting: During the first eighteen months 6) Percentage of relapses and treatment failures comparing the two groups: During the first eighteen months 7) Mean change in IMPACT III score at 3, 6, 9, 12 months | — |
Countries
Italy
Contacts
Public ContactDipartimento di Scienze Mediche Tra
Università di Napoli "Federico II
Outcome results
None listed