|drug578||C3+ Holter Monitor Wiki||0.35|
|drug4040||placebo rinse Wiki||0.35|
|drug601||CHX0.12+CPC0.05 oral rinse (PerioAidActive Control) Wiki||0.35|
|drug599||CHLORPROMAZINE (CPZ) Wiki||0.35|
|drug3095||Serological analyses to be lead on a pre-existing biobank Wiki||0.35|
|drug588||CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc Wiki||0.35|
|drug2692||Psychoeducation and Safety Wiki||0.35|
|drug582||CAP-1002 Allogeneic Cardiosphere-Derived Cells Wiki||0.35|
|drug594||CETA Short Session (CSS) Wiki||0.35|
|drug1140||EU-approved RoActemra Wiki||0.35|
|drug3506||Traditional antirheumatic drugs Wiki||0.35|
|drug2519||Placebo Administration Wiki||0.18|
|drug4071||questionnaire assesment Wiki||0.16|
|drug3223||Standard of Care (SOC) Wiki||0.16|
|D001172||Arthritis, Rheumatoid NIH||0.85|
|D015535||Arthritis, Psoriatic NIH||0.20|
|D011111||Polymyalgia Rheumatica NIH||0.20|
|D013700||Giant Cell Arteritis NIH||0.20|
|D012859||Sjogren's Syndrome NIH||0.18|
|D001327||Autoimmune Diseases NIH||0.16|
|D003095||Collagen Diseases NIH||0.14|
|D008180||Lupus Erythematosus, Systemic NIH||0.14|
|D012216||Rheumatic Diseases NIH||0.12|
|D059350||Chronic Pain NIH||0.11|
|D003141||Communicable Diseases NIH||0.03|
There are 8 clinical trials
This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and ~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.
Description: Number of patients developing signs and symptoms of Covid-19 or other infectionsMeasure: Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group Time: 12 months
Description: Number of patients developing Covid-19 infectionMeasure: Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group Time: 12 months
Description: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of actionMeasure: Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action Time: 12 months
Description: Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposureMeasure: Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients Time: 6 months
Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration. In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression. During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients. The present study is an "emergency" being realize before the end of the quarantine.
Description: Self reported questionnaire with questions to assess the characteristic,intensity of pain on quality of life, and consumption of analgesic.Measure: self-reported questionnaire for painful Time: maximum 1 week from baseline on
The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus. These compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately active rheumatoid arthritis (RA).
Description: serum levelMeasure: immunoglobulin mesurement Time: 1 month
The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.
Description: Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARDMeasure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis Time: 1 Day
The coronavirus disease 2019 (COVID-19) pandemic is a potentially fatal disease that represents a great global public health concern. In European countries such as Spain, Italy, Germany, Portugal, England and France, the pandemic has been of utmost importance. To date, no treatment has been robustly validated, and two theoretically opposite therapeutic strategies are proposed, based either on antiretroviral therapy or on immunomodulating agents. In this complex context, people living with immune-mediated inflammatory diseases (IMID) raise specific concerns due to their potentially increased risk of infections or of severe infections. Among IMID, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, spondyloarthritis and giant cell arteritis are some key diseases. In this cross-sectional, observational, multi-centric study, the investigators aim to assess both clinical and serological prevalence of COVID-19 among samples of IMID patients in Europe. In parallel, the investigators aim to compare the prevalence of COVID-19 seroconversion across these five IMIDs, their penetration across different 6 European countries (France, Italy, Spain, Germany, United Kingdom and Portugal), and to assess the severity of COVID-19 in these patients. Moreover, changes in treatment will be assessed, including immunomodulatory tapering or discontinuation, its causes over the outbreak period, as well as the incidence of IMID flares and their severity over this same period. Finally, patient's perceptions towards the pandemic will be evaluated and compared to medication beliefs. Data will be collected through questionnaires during medical visit or phone consultation and serological tests will be performed within routine blood collection. As so, all study procedures are comprised within usual care. Through this study the investigators expect to have a better knowledge of the clinical and serological prevalence of COVID-19 in IMID across Europe, along with the psychological, clinical, and therapeutic impact of COVID-19 in this particular patient population.
Description: ELISA tests for COVID-19 antibodiesMeasure: COVID-19 seroconversion Time: 1 day, during routine blood collection
Description: Case report form filled by the health professionalMeasure: COVID-19 infection Time: During medical visit or phone consultation, up to 2 hours
Description: Descriptive analysis for each disease's rateMeasure: Seroconversion rate by disease Time: 1 day, during routine blood collection
Description: Descriptive analysis for each country's rateMeasure: Penetration across Europe Time: 1 day, during routine blood collection
Description: World Health Organization ordinal scale for clinical improvement at any given point of the infection, going from 0 to 8, where higher scores means worse outcome.Measure: COVID-19 severity Time: During medical visit, up to 1 hour
Description: Descriptive analysis for overall and COVID-19-linked mortality ratesMeasure: COVID-19 mortality rate Time: During contact with family members, up to 1 hour
Description: Case report form filled by the health professionalMeasure: COVID-19 impact on immunomodulatory treatment Time: During medical visit, up to 1 hour
Description: Case report form filled by the patientMeasure: Patient-reported flares Time: During medical visit, up to 1 hour
Description: Fear of COVID-19 scale, going from 7 to 35, where higher scores means worse outcome.Measure: Patient's fears towards COVID-19 Time: During medical visit, up to 1 hour
Description: Beliefs about Medicines Questionnaire, going from 11 to 55, with higher scores indicating stronger beliefs regarding medicine.Measure: Patient's beliefs in their medicines towards COVID-19 Time: During medical visit, up to 1 hour
Due to the Covid-19 worldwide outbreak, fragile patients with immune diseases, notably rheumatoid arthritis (RA), have to be even more specifically and carefully followed-up. However, it has been shown that false postive serological results often occured while detecting antibodies directed against SARS-CoV-2 in patients with positive rheumatodoid factor (RF). The investigators propose here to investigated this issue. Therefore, the investigators will test three different immunoassays on this specific population. The investigators aim to establish these assays specificity and the levels of RF for which there is a risk of anti-SARS-CoV-2 false positivity and thus ensure a better follow-up of RA patients. The RF isotype will be analysed to determine whether there is a correlation and the impact of the presence of anti-CCP (citrullinated cyclic antipeptide antibodies) will be studied and assessed.
Description: Evaluate the false positive results rate when using each one of the three SARS-CoV-2 serology tests in patients with rheumatoid factor plasma levels, so as to define the specificity of these tests in this RA population. all serum samples will be tested by the 3 different immunoassays. The RF plasma levels have already been measured (routine exam) and are written in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the question.Measure: Evaluate the false positive results rate Time: 4 months
Description: Characterize the RF isotype (IgG, IgM or IgA) associated with the false positivity of the test.all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questionsMeasure: Characterize the RF isotype (IgG, IgM or IgA) associated Time: 4 months
Description: Determine the influence of RA on the false positivity rate in subjects with negative RF titer. All serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questionsMeasure: Determine the influence of RA on the false positivity rate in subjects Time: 4 months
Description: Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.Measure: Assess the influence of the presence of anti-CCP on the false positivity of the SARS-CoV-2 test Time: 4 months
Description: Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test : all serum samples will be tested by the 3 different immunoassays. The RF isotype will be established using the routine method and the results of anti-CCP and RF plasma levels are already known and this information is available in the patients files. The results will be analysed, the data proceeded and hopefully we will be able to answer the questions.Measure: Assess the relation between the RF plasma levels and the false positivity of the SARS-CoV-2 test Time: 4 months
Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.
Description: Realtion between hydroxychloroquine use and COVID-19 infectionMeasure: The risk of COVID-19 infection among RA patients Time: 12 week
Description: Number of cases and number of hospitalization daysMeasure: The incidence of hospitalization for Covid-19 patients. Time: 12 week
The purpose of the study is to compare the efficacy, safety and immunogenicity of MSB11456 and EU approved RoActemra® in participants with moderately to severely active rheumatoid arthritis. Participants will be randomized at the beginning of the Core Treatment Period (Baseline to Week 24) to receive either MSB11456 or EU approved RoActemra® once a week (QW). At the beginning of the Extended Treatment Period (Week 24 to Week 52), participants who received RoActemra® will be re-randomized to either continue receiving RoActemra® QW or switch to receive MSB11456 QW.
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports