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

NCT ID: NCT05045001

Last Updated: 2022-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-02

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis Idiopathic Juvenile Arthritis Giant Cell Arteritis Still Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Moya, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Luis Sainz

Role: CONTACT

679743541 ext. +34

Facility Contacts

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Luis Sainz

Role: primary

679743541 ext. +34

Other Identifiers

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IIBSP-IIL-2020-148

Identifier Type: -

Identifier Source: org_study_id

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