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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045001
• Other study ID #: IIBSP-IIL-2020-148
• Status: Recruiting
• Start date: June 2, 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Luis Sainz
• Phone: 679743541
• Email: lsainz[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Arthritis
• Arthritis, Juvenile
• Collagen Diseases
• Giant Cell Arteritis
• Idiopathic Juvenile Arthritis
• Polymyalgia Rheumatica
• Rheumatic Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

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