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

NCT05045001 | Unknown

• 1 other identifier: IIBSP-IIL-2020-148
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \<18 years at recruitment

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples will be collected and stored following the appropriate national laws of Spain ( Ley de Investigación Biomédica 14/2007) regarding the use of human biological samples in biomedical investigation. Collection and storage approved by the organization's ethic committee.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Juvenile; Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases

Study Officials

• Patricia Moya, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Sainz

CONTACT

679743541; lsainz@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: September 16, 2021
• Study Start: June 2, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)