Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments
COVID-19 in Inflammatory Arthritis Patients on Immunosuppressants
Plain English Summary
SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism is a Not Applicable clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Spondyloarthritis, Rheumatoid Arthritis, Covid19. This study investigates how common arthritis medications affect the body's response to COVID-19. It is for adults with rheumatoid arthritis or spondyloarthritis who are taking specific immune-suppressing drugs and have COVID-19. Participants will have blood, nasal swab, and stool samples taken to measure the virus and immune responses. There are no direct alternatives offered within this study; standard medical care for COVID-19 and arthritis would apply. The trial aims to enroll 150 participants.
Official Summary
The purpose of this study is to assess whether immunosuppressive therapies used by patients with chronic inflammatory rheumatic diseases have an impact on the viral load and the humoral and cellular responses during viral infection with SarSCoV2, compared to members of their family cluster infected with the same viral strain.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with rheumatoid arthritis or spondyloarthritis who have tested positive for COVID-19. Patients must be currently taking certain medications like methotrexate, anti-TNF, or JAK inhibitors. Individuals who are pregnant, breastfeeding, or under legal protection cannot participate. Family members living with a participant can also join as controls if they have COVID-19. This trial is studying Spondyloarthritis, Rheumatoid Arthritis, Covid19, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how much virus is present in the body and how the immune system (specifically T and B cells and antibodies) responds to COVID-19, helping to understand infection control i The specific primary outcome measures are: Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (up to Day 30); Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (between Day 30 and Day 90); Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (up to Day 30); Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (between Day 30 and Day 90); Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (6 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it helps understand how treatments for chronic inflammatory rheumatic diseases might influence the severity and duration of COVID-19 infection. This research targets Spondyloarthritis, Rheumatoid Arthritis, Covid19, where improved treatment options are needed.
Investor Insight
This trial addresses a critical question during the pandemic regarding vulnerable patient populations, potentially informing treatment guidelines and impacting the market for immunosuppressive therapi
Is This Trial Right for Me?
Ask your doctor if your current arthritis medication might affect your COVID-19 infection and if participating in this study is right for you. Participation involves providing biological samples (blood, nasal swabs, stool) and potentially having family members join as controls. The study aims to track viral load and immune responses over several months. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 150 participants
Interventions
- BIOLOGICAL: blood tests — Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)
- BIOLOGICAL: Nasopharyngeal swabs — SarS-Cov-2 viral load assessment
- BIOLOGICAL: Stools — SarS-Cov-2 viral load assessment
Primary Outcomes
- Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (up to Day 30)
- Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (between Day 30 and Day 90)
- Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (up to Day 30)
- Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (between Day 30 and Day 90)
- Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (6 Months)
Full Eligibility Criteria
Inclusion Criteria: cases * Patient with spondyloarthritis fulfilling the ASAS criteria * Patients with rheumatoid arthritis fulfilling the ACR/EULAR criteria and * Immunosuppressive therapy: Methotrexate, leflunomide, anti-TNF, Anti-IL6R, abatacept, rituximab, Jak inhibitors (tofacitinib or baricitinib) And * infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan) Controls: * Family cluster member confined to the same location as the index subject * Infected with the SarS-Cov-2 (positive PCR and/or serology and/or CT-scan) Exclusion Criteria: cases and controls * Pregnant woman * Breastfeeding woman * Immunosuppressed subject for members of the familiar cluster of the index subject * Patient with no social security * Patients whose freedom is limited by the judicial or administrative authority * Patients under legal protection
Trial Locations
- Cochin hospital, Paris, France
Frequently Asked Questions
What is clinical trial NCT04584541?
NCT04584541 is a Not Applicable INTERVENTIONAL study titled "SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism." It is currently terminated and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 150 participants.
What conditions does NCT04584541 study?
This trial investigates treatments for Spondyloarthritis, Rheumatoid Arthritis, Covid19. The primary condition under study is Spondyloarthritis.
What treatments are being tested in NCT04584541?
The interventions being studied include: blood tests (BIOLOGICAL), Nasopharyngeal swabs (BIOLOGICAL), Stools (BIOLOGICAL). Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)
What does Not Applicable mean for NCT04584541?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04584541?
This trial is currently "Terminated." It started on 2020-06-11. The estimated completion date is 2022-02-21.
Who is sponsoring NCT04584541?
NCT04584541 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04584541?
The trial aims to enroll 150 participants. The trial status is terminated.
How is NCT04584541 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT04584541?
The primary outcome measures are: Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (up to Day 30); Detection of SarS-Cov-2 RNA in feces and nasopharyngeal swabs (between Day 30 and Day 90); Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (up to Day 30); Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (between Day 30 and Day 90); Detection and quantification of IgG, IgM and IgA specific for SarS-Cov-2 N and S proteins in blood (6 Months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04584541 being conducted?
This trial is being conducted at 1 site, including Paris (France).
Where can I find official information about NCT04584541?
The official record for NCT04584541 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04584541. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04584541 testing in simple terms?
This study investigates how common arthritis medications affect the body's response to COVID-19. It is for adults with rheumatoid arthritis or spondyloarthritis who are taking specific immune-suppressing drugs and have COVID-19.
Why is this trial significant?
This trial is important because it helps understand how treatments for chronic inflammatory rheumatic diseases might influence the severity and duration of COVID-19 infection.
What are the potential risks of participating in NCT04584541?
Risks are generally related to the procedures, such as discomfort from blood draws or nasal swabs. Potential side effects could include those associated with COVID-19 infection itself, which may be influenced by immunosuppressive therapy. The study was terminated, so there is no further risk of participation. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04584541?
Ask your doctor if your current arthritis medication might affect your COVID-19 infection and if participating in this study is right for you. Participation involves providing biological samples (blood, nasal swabs, stool) and potentially having family members join as controls. The study aims to track viral load and immune responses over several months. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04584541 signal from an investment perspective?
This trial addresses a critical question during the pandemic regarding vulnerable patient populations, potentially informing treatment guidelines and impacting the market for immunosuppressive therapi This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have blood, nasal swab, and stool samples taken to measure the virus and immune responses. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.