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Risk of Incident IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID

NCT05696106 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 750000

Last updated 2023-04-24

No results posted yet for this study

Summary

Individuals with immune-mediated inflammatory diseases (IMIDs) are at increased risk of developing other IMIDs, possibly through shared pathogenic inflammatory pathways, and up to 25% of patients with IMIDs have at least one other IMID. Additionally, a concomitant diagnosis of a second IMID is associated with a higher burden of disease, which usually requires therapeutic escalation. Thus, this risk should be taken into account in the benefit-risk balance of IMIDs-related treatment. While the risk of other major adverse events, such as serious infection, cancer, and cardiovascular events, have been assessed in patients exposed to immunosuppressive drugs and biologics, the impact of these drugs on the risk of incident IMIDs remains largely unknown.

The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either inflammatory bowel disease, inflammatory rheumatic diseases, or cutaneous psoriasis).

Conditions

  • Inflammatory Disease

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-02
Primary Completion
2023-12-15
Completion
2024-01-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696106 on ClinicalTrials.gov