Rheumatoid ArthritisNCT05045001
Pharmacogenetic Studies on Anti-IL-6 Receptor Monoclonal Antibodies on the Treatment of Rheumatic Diseases
An observational study of Rheumatoid Arthritis and Idiopathic Juvenile Arthritis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Idiopathic Juvenile Arthritis, Giant Cell Arteritis
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- <18 years at recruitment
- Another rheumatic disease different of the ones in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Luis Sainz, 679743541 ext. +34, lsainz@santpau.cat
About this study
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
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.
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Juvenile, Giant Cell Arteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28-C-reactive Protein (CRP) change
Activity measure for patients with Rheumatoid Arthritis (RA)
Measured: at 6 months
Rate of adverse events
Known adverse events during treatment with anti-IL6R drugs
Measured: During treatment with anti-IL6R drugs
CRP change
Acute phase reactant reduction in the other diseases different of RA.
Measured: 6 months
Erythrocyte sedimentation rate (ESR) change
Acute phase reactant reduction in the other diseases different of RA.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start2 Jun 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Moya, Doctor, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045001
- Sponsor's protocol ID
- IIBSP-IIL-2020-148
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05045001
- Acronym / sponsor ID
- IIBSP-IIL-2020-148
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- <18 years at recruitment
- Another rheumatic disease different of the ones in the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DAS28-C-reactive Protein (CRP) change
Time frame: at 6 months
Activity measure for patients with Rheumatoid Arthritis (RA)
Rate of adverse events
Time frame: During treatment with anti-IL6R drugs
Known adverse events during treatment with anti-IL6R drugs
CRP change
Time frame: 6 months
Acute phase reactant reduction in the other diseases different of RA.
Erythrocyte sedimentation rate (ESR) change
Time frame: 6 months
Acute phase reactant reduction in the other diseases different of RA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Moya, Doctor principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Idiopathic Juvenile Arthritis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Sainz (679743541 ext. +34, lsainz@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28-C-reactive Protein (CRP) change (time frame: at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.