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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Luis Sainz; Phone Number: +34 679743541; Email: lsainz@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Luis Sainz; Phone Number: +34 679743541; Email: lsainz@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients being followed-up in the Hospital de la Santa Creu i Sant Pau, diagnosed of Rheumatoid Arthritis, Idiopathic Juvenile Arthritis, Still disease or Giant Cell Arteritis treated with anti-IL6R drugs.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Patricia Moya, Doctor, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2021
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (ACTUAL): September 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Arthritis; Rheumatic Diseases; Collagen Diseases; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Arthritis, Juvenile
• Other Study ID Numbers: IIBSP-IIL-2020-148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No