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

NCT03370601 | Terminated

• 2 other identifiers: 2015_232015-A00940-49
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

crohn's disease; ulcerative colitis; infliximab; loss of response

Outcome Measures

Primary Outcomes (1)

• 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.

  At Week 52

Secondary Outcomes (7)

• Number of patients in deep remission

  At Week 52

• Number of patient in remission and clinical response

  At week 16

• infliximab blood concentration

  Baseline, week 16 ad week 52

• infliximab antibodies concentration

  Baseline, week 16 ad week 52

• economic criteria

  At week 52

Study Arms (2)

Optimisation strategy

OTHER

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

Drug: Infliximab

Addition strategy

OTHER

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

Drug: Mercaptopurine; Drug: Azathioprine; Drug: Infliximab

Interventions

Infliximab DRUG

Infliximab 10mg/kg every 8 weeks

Optimisation strategy

Mercaptopurine DRUG

6-mercaptopurine 1 à 1,5 mg/kg

Also known as: addition strategy with 6-mercaptopurine in second intention

Addition strategy

Azathioprine DRUG

Azathioprine 2 à 2.5mg/kg/j

Also known as: addition strategy with azathioprine in first intention

Addition strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Related Publications (1)

• Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.

  PMID: 40013523 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab; Mercaptopurine; Azathioprine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thionucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Benjamin Pariente, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: January 3, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)