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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Recruiting

CT.gov ID

NCT05045001

Collaborator

(none)

140

Enrollment

Location

Anticipated Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Idiopathic Juvenile Arthritis Giant Cell Arteritis Still Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Observational Retrospective Studies on Single Nucleotide Variants (SNPs) on the Interleukin-6 Receptor (IL6R) and Their Influence on the Response to Treatment and Safety in Patients With Specific Rheumatic Diseases

Actual Study Start Date :

Jun 2, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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