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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optimisation strategy

increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks

Group Type OTHER

Infliximab

Intervention Type DRUG

Infliximab 10mg/kg every 8 weeks

Addition strategy

same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine

Group Type OTHER

Mercaptopurine

Intervention Type DRUG

6-mercaptopurine 1 à 1,5 mg/kg

Azathioprine

Intervention Type DRUG

Azathioprine 2 à 2.5mg/kg/j

Infliximab

Intervention Type DRUG

Infliximab 5mg/kg every 8 weeks

Interventions

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Infliximab

Infliximab 10mg/kg every 8 weeks

Intervention Type DRUG

Mercaptopurine

6-mercaptopurine 1 à 1,5 mg/kg

Intervention Type DRUG

Azathioprine

Azathioprine 2 à 2.5mg/kg/j

Intervention Type DRUG

Infliximab

Infliximab 5mg/kg every 8 weeks

Intervention Type DRUG

Other Intervention Names

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addition strategy with 6-mercaptopurine in second intention addition strategy with azathioprine in first intention

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No