Inflammatory Bowel Diseases
Conditions
Keywords
crohn's disease, ulcerative colitis, infliximab, loss of response
Brief summary
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.
Interventions
DRUGInfliximab
Infliximab 10mg/kg every 8 weeks
DRUGMercaptopurine
6-mercaptopurine 1 à 1,5 mg/kg
DRUGAzathioprine
Azathioprine 2 à 2.5mg/kg/j
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with ulcerative colitis or crohn's disease * treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab * active disease ( HBI \> 5 for CD patients or SCCAI\> 6 for UC patients) * patients treated with infliximab only at the time of loss of response
Exclusion criteria
* Patients with CD with ano perineal lesions and without luminal activity * patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate * patients with acute severe flare (HBI\>12 for CD patients and Lichtiger score \> 10 for UC patients) * pregnant female * patients with anal disease alone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients in Clinical remission | At Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient in remission and clinical response | At week 16 | 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. |
| infliximab blood concentration | Baseline, week 16 ad week 52 | — |
| infliximab antibodies concentration | Baseline, week 16 ad week 52 | — |
| Number of patients in deep remission | At Week 52 | clinical remission associated with endoscopic remission (CDEIS \<3 for CD patients or Mayo score\<2 for UC patients) |
| number of patient with adverse effects and allergic reactions with infliximab | At week 52 | — |
| Inflammatory bowel disease questionnaire (score IBDQ) | Baseline and week 52 | quality of life |
| economic criteria | At week 52 | medical fees in each arm |
Countries
France
Outcome results
None listed