Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DR-2012-589 | Other Identifier | CNIL |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Apsen Farmaceutica S.A. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Inflammatory bowel disease (IBD) groups together Crohn's Disease (CD) and ulcerative colitis (UC). Its prevalence is high representing approximately 0.4% of the population. The peak incidence for these diseases ranges between 2 and 30 years of age with a second peak for CD recently reported at 60. These diseases develop over time into complications requiring in 2/3 of cases surgical resection procedures in CD and colectomy in over 20% of cases. Cohort data has recently shown that the early use of azathioprine from the first year would decrease the need for surgery. Aside from biologics, azathioprine is the most widely used immunosuppressant in IBD management. Its metabolism is highly variable in the overall population since over 10% of patients are slow metabolizers and 15% fast metabolizers. This explains partly treatment failures and side effects with thiopurines. A lot of research has shown that metabolite measurement of azathioprine (6-TGN end methylated derivatives) could be used clinically even if these results remain controversial. In fact, their positive predicative value (PPV) in clinical response does not exceed 60%. This costly testing cannot be done everywhere, is not reimbursed by national health services, and may not be used in some countries. It is, however, key in order optimize these drugs at a time when only two anti-TNFs are possible in the event of failure on thiopurines. Older studies have shown that MCV and lymphonenia could be markers for thiopurine impregnation. Recently, an American study provided a mathematic formula enabling to achieve over 80% PPV for the clinical response on AZA but this calculation needs to be confirmed and it is, moreover, patented (costly).
We suggest developing a predictive score for clinical thiopurines in IBD based on routine lab data obtained when monitoring patients on thiopurines. This initial work will enable to identify clinical and/or lab factors in order to develop a score based on an international, multicenter, cross-section study. Two hundred patients with treatment failure on thiopurines will be included and at least as many in clinical remission on thiopurines. A subsequent longitudinal study, over all recruiting centers will enable to validate the score. Finally, a prospective study will assess the clinical impact of the optimization of this score in patients sustaining a treatment failure on thiopurines. This score - if confirmed - will subsequently be at no additional cost in the management of patients on thiopurines.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Inflammatory Bowel Disease | patients with Crohn's Disease or Ulcerative Colitis meeting clinical, endoscopic and histological criteria and on thiopurines at stable doses for at least 3 months, monotherapy or combined with corticotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collection | Other | data collection will be carried out by the investigator during a standard hospitalization of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patient with therapeutic failure on thiopurines | A therapeutic failure on thiopurines will be considered to be any patient with at least one of the following criteria:
| day 0 (inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| number of patient in clinical remission on thiopurines | A clinical remission shall be considered as any patients with at least one of the following criteria:
| day 0 (inclusion) |
Not provided
Inclusion Criteria:
AZATHIOPRINE at the dose of 2 to 2.5 mg/kg/day, regular oral dosing for 3 months or PURINETHOL at the dose of 1 to 1.5 mg/kg/day, regular oral dosing for 3 months
Exclusion Criteria:
Not provided
Not provided
patients with Crohn's Disease or Ulcerative Colitis and on thiopurines at stable doses for at least 3 months, monotherapy or combined with corticotherapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xavier ROBLIN, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Jean Minjoz | Besançon | 25030 | France | |||
| CHU Caen |
Not provided
Not provided
Not provided
Not provided
| Caen |
| 14033 |
| France |
| CHU Dijon | Dijon | 21079 | France |
| CHRU Lilles | Lilles | 59037 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU Nancy | Nancy | 54511 | France |
| CHU Nantes - Hôtel-Dieu | Nantes | 44093 | France |
| CHU Nice | Nice | 06200 | France |
| CHR Orléans | Orléans | 45000 | France |
| Hôpital Saint-Antoine | Paris | 75012 | France |
| CHU Bordeaux | Pessac | 33604 | France |
| CH Lyon Sud | Pierre-Bénite | 69310 | France |
| CHU Reims | Reims | 51092 | France |
| CHU Rennes | Rennes | 35033 | France |
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
| 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 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided