Pharmacogenetic Studies on Anti-IL-6 Receptor Monoclonal Antibodies on the Treatment of Rheumatic Diseases

• Conditions: Still Disease; Rheumatoid Arthritis; Idiopathic Juvenile Arthritis; Giant Cell Arteritis

• Registration Number: NCT05045001
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology.

The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Diagnosis of Rheumatoid Arthritis by the American College of Rheumatology (ACR) 2010 criteria or
• Diagnosis of Giant Cell Arteritis by the International League of Associations for Rheumatology (ILAR) criteria or
• Diagnosis of Still disease by classification criteria (Yamaguchi et al.) or
• Diagnosis of Idiopathic Juvenile Arthritis by ACR 1990 criteria.
• All of the previous must have been treated with anti-IL-6R monoclonal antibodies in the last 5 years

Exclusion Criteria

• <18 years at recruitment
• Another rheumatic disease different of the ones in the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRP change	6 months	Acute phase reactant reduction in the other diseases different of RA.
Rate of adverse events	During treatment with anti-IL6R drugs	Known adverse events during treatment with anti-IL6R drugs
DAS28-C-reactive Protein (CRP) change	at 6 months	Activity measure for patients with Rheumatoid Arthritis (RA)
Erythrocyte sedimentation rate (ESR) change	6 months	Acute phase reactant reduction in the other diseases different of RA.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain