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OpenTrials
Completed

NCT Number: NCT03964883

Infliximab Blood Test in Crohn's Disease

Ano-perineal lesions are the first signs of Crohn's disease in 1/3 to 1/2 of cases. They are most often associated with a poor prognosis of the disease and their management is complex and difficult because of the dilapidated and recurrent nature of lesions with significant repercussions on continence and quality of life.

The treatment of these lesions is most often medical and surgical, consisting of drainage of the suppurative lesions and/or the use of biotherapy +/- combined with an immunosuppressant.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, France

About this study

Pharmacological dosages of biotherapies show a significant correlation between the highest rates and the achievement of clinical and endoscopic remission. Therapeutic monitoring by dosing the residual levels of these biotherapies and specific antibodies, particularly in the event of loss of response in order to adapt the treatment, has become common for luminal damage. Among these biotherapies, infliximab is the first-line treatment, particularly for ano-perineal disease. Effective therapeutic levels are known for luminal damage and must be between 3 and 7 mcg/ml but these levels have not yet been determined for ano-perineal damage. There are only two recently published studies available that suggest levels probably significantly higher than those required for luminal damage ≥ 10 mcg/l

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients followed for Chron's diseases within Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and treated with Infliximab for at least 6 months.

Exclusion criteria

  • All patients with therapeutic compliance problems

Treatment and study plan

Primary outcomes

  1. Identify doses and residual levels of infliximab in patients affected by ano-perineal Crohn's disease in remission

    Time frame: Time of inclusion

    doses and residual levels of infliximab in remission patients will be collected to determine minimum, maximum and average values.

Secondary outcomes

  1. Compare doses and residual rates of infliximab in patients affected by Crohn's disease in remission with luminal impairment alone versus ano-perineal +/- luminal

    Time frame: Time of inclusion

    Doses and infliximab's residual levels will be collected from patients affected by Crohn's disease in remission with luminal alone and from patients in remission with ano-perineal +/- luminal for comparison

  2. Evaluate the proportion of patients in luminal remission with active ano-perineal disease

    Time frame: Time of inclusion

    Calculation of patient's proportion with active ano-perineal disease on total of all patients in luminal remission.

  3. Compare residual doses and infliximab levels in patients with ano-perineal disease in remission versus active

    Time frame: Time of inclusion

    Infliximab doses, infliximab residual levels will be collected from patients affected by Crohn's disease with ano-perineal involvement to compare remission patients and patients with active disease.

  4. Anti-infliximab antibodies presence (yes/no) in patients with ano-perineal disease in remission versus active

    Time frame: Time of inclusion

    Anti-infliximab antibodies will be collected from patients affected by Crohn's disease with ano-perineal involvement to compare remission patients and patients with active disease.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 28, 2019
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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