Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases

University Hospital, Lille9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Diseases

Interventions

InfliximabDRUG

Infliximab 10mg/kg every 8 weeks

MercaptopurineDRUG

6-mercaptopurine 1 à 1,5 mg/kg

AzathioprineDRUG

Azathioprine 2 à 2.5mg/kg/j

Infliximab

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU, Hôpital Claude Huriez

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: At Week 52

Secondary Outcomes

Number of patients in deep remission

clinical remission associated with endoscopic remission (CDEIS \<3 for CD patients or Mayo score\<2 for UC patients)

Time frame: At Week 52

Number of patient in remission and clinical response

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.

Time frame: At week 16

infliximab blood concentration

Time frame: Baseline, week 16 ad week 52

infliximab antibodies concentration

Time frame: Baseline, week 16 ad week 52

economic criteria

medical fees in each arm

Time frame: At week 52

number of patient with adverse effects and allergic reactions with infliximab

Time frame: At week 52

Inflammatory bowel disease questionnaire (score IBDQ)

quality of life

Time frame: Baseline and week 52

Data from ClinicalTrials.gov

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