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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05045001

Enrollment

140

Registered

2021-09-16

Start date

2021-06-02

Completion date

2022-12-31

Last updated

2022-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis, Idiopathic Juvenile Arthritis, Rheumatoid Arthritis, Still Disease

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Contacts

Primary ContactLuis Sainz

lsainz@santpau.cat679743541

Outcome results