CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D008180: Lupus Erythematosus, Systemic NIH

(Synonyms: Lupus Erythematosus, Sy, Lupus Erythematosus, Syst, Lupus Erythematosus, Systemic)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (9)


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

Correlated MeSH Terms (11)


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

Correlated HPO Terms (5)


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

Clinical Trials


1 A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus

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.

NCT03724916 Systemic Lupus Erythematosus Lupus Erythematosus, Systemic Drug: TAK-079 Drug: TAK-079 Placebo
MeSH:Lupus Erythematosus, Systemic
HPO:Systemic lupus erythematosus

Primary Outcomes

Measure: Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

Time: Up to Week 36

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 36

Measure: Percentage of Participants With Greater Than or Equal to (>=) 1 Adverse Event (AE) Leading to Treatment Discontinuation

Time: Up to Week 36

Secondary Outcomes

Measure: Cmax: Maximum Observed Plasma Concentration for TAK-079

Time: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose

Measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079

Time: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose

Description: 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 85

Description: 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 85

Description: 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 85

Measure: Number of Participants With Positive Anti-drug Antibodies

Time: Baseline up to Day 85

2 COVID-19 Infection in Vulnerable Patients With Inflammatory Rheumatic Diseases

The 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.

NCT04335747 Rheumatoid Arthritis Psoriatic Arthritis Axial Spondyloarthritis Systemic Lupus Erythematosus Giant Cell Arteritis Other: COVID-19 infection
MeSH:Arthritis Arthritis, Psoriatic Rheumatic Diseases Polymyalgia Rheumatica Giant Cell Arteritis Arteritis Lupus Erythematosus, Systemic Collagen Diseases
HPO:Arteritis Arthritis Polyarticular arthritis Systemic lupus erythematosus

Primary Outcomes

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/inclusion

Secondary Outcomes

Description: 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/inclusion

Description: 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 1

3 Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

This 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.

NCT04345159 SARS-CoV-2 Systemic Lupus Erythematosus Rheumatoid Arthritis Sjogren's Syndrome Psoriatic Arthritis Other: Questionnaire by phone call
MeSH:Arthritis Arthritis, Psoriatic Sjogren's Syndrome Lupus Erythematosus, Systemic Autoimmune Diseases
HPO:Arthritis Autoimmunity Polyarticular arthritis Systemic lupus erythematosus

Primary Outcomes

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 inclusion

4 Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus

The 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)

NCT04355702 Systemic Lupus Erythematosus Covid-19
MeSH:Lupus Erythematosus, Systemic
HPO:Systemic lupus erythematosus

Primary Outcomes

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 day

Secondary Outcomes

Description: 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 day

5 Use of Telemedicine for Follow-up of Systemic Lupus Erythematosus ("TeleSLE") in the COVID-19 Outbreak: a Pragmatic Randomised Controlled Trial

Background 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.

NCT04368299 SLE Other: Telemedicine Other: Standard care
MeSH:Lupus Erythematosus, Systemic
HPO:Systemic lupus erythematosus

Primary Outcomes

Measure: The percentage of patients in remission or LLDAS at one year.

Time: 1 year

Secondary Outcomes

Measure: Direct and indirect costs after one year.

Time: 1 year

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 year

Description: 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 year

Measure: Rates of adverse reaction and severe adverse reaction, including contracting COVID-19 infection, after one year.

Time: 1 year

Measure: Numbers of clinic visits, hospitalization, overall in-person hospital visits in one year.

Time: 1 year

Description: 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 year

Description: 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 year

6 Prevalence, Seroconversion and Impact of COVID-19 in Autoimmune Diseases in Europe

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.

NCT04397237 COVID-19 Systemic Lupus Erythematosus Sjogren's Syndrome Axial Spondyloarthritis Rheumatoid Arthritis Giant Cell Arteritis
MeSH:Arthritis Arthritis, Rheumatoid Sjogren's Syndrome Spondylarthritis Polymyalgia Rheumatica Giant Cell Arteritis Arteritis Lupus Erythematosus, Systemic Autoimmune Diseases
HPO:Arteritis Arthritis Autoimmunity Polyarticular arthritis Rheumatoid arthritis Systemic lupus erythematosus

Primary Outcomes

Description: ELISA tests for COVID-19 antibodies

Measure: COVID-19 seroconversion

Time: 1 day, during routine blood collection

Description: Case report form filled by the health professional

Measure: COVID-19 infection

Time: During medical visit or phone consultation, up to 2 hours

Secondary Outcomes

Description: Descriptive analysis for each disease's rate

Measure: Seroconversion rate by disease

Time: 1 day, during routine blood collection

Description: Descriptive analysis for each country's rate

Measure: 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 rates

Measure: COVID-19 mortality rate

Time: During contact with family members, up to 1 hour

Description: Case report form filled by the health professional

Measure: COVID-19 impact on immunomodulatory treatment

Time: During medical visit, up to 1 hour

Description: Case report form filled by the patient

Measure: 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


HPO Nodes