Name (Synonyms) | Correlation | |
---|---|---|
drug2797 | TAK-079 Placebo Wiki | 0.41 |
drug532 | COVID-19 Antibody testing Wiki | 0.41 |
drug562 | COVID-19 infection Wiki | 0.41 |
drug2314 | Questionnaire by phone call Wiki | 0.41 |
drug2796 | TAK-079 Wiki | 0.41 |
drug531 | COVID-19 Wiki | 0.29 |
drug2850 | Telemedicine Wiki | 0.20 |
drug535 | COVID-19 Convalescent Plasma Wiki | 0.18 |
drug2692 | Standard care Wiki | 0.14 |
Name (Synonyms) | Correlation | |
---|---|---|
D001167 | Arteritis NIH | 0.58 |
D012859 | Sjogren's Syndrome NIH | 0.58 |
D011111 | Polymyalgia Rheumatica NIH | 0.47 |
D013700 | Giant Cell Arteritis NIH | 0.47 |
D025241 | Spondylarthritis NIH | 0.41 |
D001327 | Autoimmune Diseases NIH | 0.41 |
D015535 | Arthritis, Psoriatic NIH | 0.41 |
D001168 | Arthritis NIH | 0.34 |
D003095 | Collagen Diseases NIH | 0.20 |
D012216 | Rheumatic Diseases NIH | 0.17 |
D001172 | Arthritis, Rheumatoid NIH | 0.14 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002725 | Systemic lupus erythematosus HPO | 1.00 |
HP:0012089 | Arteritis HPO | 0.58 |
HP:0002960 | Autoimmunity HPO | 0.41 |
HP:0001369 | Arthritis HPO | 0.34 |
HP:0001370 | Rheumatoid arthritis HPO | 0.14 |
There are 6 clinical trials
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.
Description: The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 definitions of Grade 1 through Grade 5. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measure: Number of Participants With Grade 3 or Higher TEAEs Time: Up to Week 36Description: Immune cell subsets will include plasma cells, plasma blast (PBs), natural killer (NK) cells, B cells, T cells, monocytes, and total lymphocytes.
Measure: Number of Participants With Change From Baseline In Immune Cell Subsets Time: Baseline up to Day 85Description: CD38 expression and receptor occupancy will be evaluated for plasma cells, PBs, NK cells, B cells, T cells, and monocytes.
Measure: Number of Participants With Change From Baseline in (Cluster of Differentiation 38) CD38 Expression Level and Receptor Occupancy Time: Baseline up to Day 85Description: Cytokine measurements will be assessed from baseline at different timepoints for placebo and each TAK-079 dose level.
Measure: Change From Baseline in Cytokines Level Time: Baseline up to Day 85The trial is a prospective, observational study aiming to identify risk factors for serious COVID-19 infection by evaluating clinical measures and biomarkers of inflammation in patients with inflammatory rheumatic disease hospitalized with COVID-19 compared with control groups.
Description: The objective is to examine whether increased disease activity leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease
Measure: Disease activity Time: Last registration of disease activity in the medical journal before admission/inclusionDescription: Examine whether immune modulating treatments protect or leads to increased risk of hospitalization due to COVID-19 in patients with inflammatory rheumatic disease.
Measure: Immune modulating treatments Time: Current immune modulating treatments at admission/inclusionDescription: Identify prognostic biomarkers by comparing serology of patients with inflammatory rheumatic disease hospitalized with COVID-19 and comparing them with the two control groups
Measure: Biomarkers Time: Blood sample 1 is taken 0-3 days after inclusion and blood sample 2 is taken 2-6 weeks after blood sample 1This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.
Description: Adjusted Odds Ratio measuring the association between an exposure to long-term hydroxychloroquine intake and a history of symptoms compatible with a COVID-19 infection.
Measure: Adjusted Odds Ratio Time: 4 months after inclusionThe Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic lupus erythematosus (SLE)
Description: prevalence and severity of Covid-19 infection in patients with SLE
Measure: prevalence and severity of Covid-19 infection in patients with SLE Time: 1 dayDescription: prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine
Measure: prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine Time: 1 dayBackground Patients with systemic lupus erythematosus (SLE) might be more susceptible to Covid-19 due to the underlying disease, co-morbidities and the use of immunosuppressive drugs. The investigators hypothesize that telemedicine (TM) can be an effective mode of health-care delivery minimizing the risk of SARS-CoV-2 exposure, while maintaining disease control in these patients. Objectives The primary aim of this study is to evaluate the effectiveness to achieve remission or lupus low disease activity state (LLDAS) using TM delivered care compared to conventional in-person outpatient follow-up in SLE. The secondary objectives are to compare the patient reported outcomes and cost between the two modes of health care delivery. Study design This is a 12-months single centered pragmatic randomized controlled study. A total of 150 enrolled patients with SLE being followed at the Prince of Wales Hospital rheumatology clinics will be randomized to either TM (TM group) or standard care (SC group) in a 1:1 ratio. Patients in the TM group will receive scheduled follow-ups via videoconferencing using a custom-made mobile app. SC group patients will continue conventional standard in-person outpatient care. The disease and patient reported outcomes as well as the health care related costs will be compared. Expected outcomes Data from this study will support the notion that TM based care is as effective as conventional in-person care in achieving disease remission or LLDAS, as well as addressing psychosocial implications to ensure the best possible care for our patients in a cost-effective manner during this pandemic.
Description: LupusQoL evaluates 8 domains including physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Questionnaire has a 5-point Likert response format (0=all the time, 1=most of the time, 2=a good bit of the time, 3=occasionally, and 4=never). Higher score means better quality of life.
Measure: The change of Lupus Quality of Life (LupusQoL) at one year. Time: 1 yearDescription: They are in a 5-point Likert response format (0=strongly disagree, 1=disagree, 2=neutral, 3=agree, and 4=strongly agree). Higher score means more confident and satisfied.
Measure: Patient confidence and satisfaction score at one year. Time: 1 yearDescription: HAQ-DI covers various common daily activities to assess disability.It consists of 8 questions. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). Higher score means higher disability.
Measure: The change of (Health Assessment Questionnaire Disability Index HAQ-DI) at one year. Time: 1 yearDescription: HADS was developed to assess anxiety and depression in medical patients. Each domain has 7 items. Each item are answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. Higher score means more likely the patient has anxiety or depression.
Measure: The change of (Hospital Anxiety and Depression Scale) HADS at one year. Time: 1 yearThe 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 antibodies
Measure: COVID-19 seroconversion Time: 1 day, during routine blood collectionDescription: Case report form filled by the health professional
Measure: COVID-19 infection Time: During medical visit or phone consultation, up to 2 hoursDescription: Descriptive analysis for each disease's rate
Measure: Seroconversion rate by disease Time: 1 day, during routine blood collectionDescription: Descriptive analysis for each country's rate
Measure: Penetration across Europe Time: 1 day, during routine blood collectionDescription: 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 hourDescription: Descriptive analysis for overall and COVID-19-linked mortality rates
Measure: COVID-19 mortality rate Time: During contact with family members, up to 1 hourDescription: Case report form filled by the health professional
Measure: COVID-19 impact on immunomodulatory treatment Time: During medical visit, up to 1 hourDescription: Case report form filled by the patient
Measure: Patient-reported flares Time: During medical visit, up to 1 hourDescription: 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 hourDescription: 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