Who is sponsoring NCT04971590?

NCT04971590 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT04971590?

Interventions in NCT04971590: Participant completed survey, Medical chart review.

What condition does NCT04971590 study?

NCT04971590 studies Systemic Lupus Erythematosus.

Is NCT04971590 still recruiting?

NCT04971590 is currently completed. Last updated 22 January 2026.

Are results published for NCT04971590?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-01-22 · How we verify

NCT04971590

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Assess Demographic, Pharmacologic, Biomarker, Clinical Features and Quality of Life (QoL) of Participants With Lupus Nephritis

Completed Results posted Last updated 22 January 2026

What this trial tests

trial testing Participant completed survey in Systemic Lupus Erythematosus in 193 participants. Completed in 31 October 2024.

Timeline

14 September 2021

Primary endpoint
31 October 2024

31 October 2024

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	193
Start date	14 September 2021
Primary completion	31 October 2024
Estimated completion	31 October 2024
Sites	6 locations across Oman, Qatar, Kuwait, United Arab Emirates

Drugs / interventions tested

Participant completed survey
Medical chart review

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Categorized by Demographic Characteristics Primary · At Baseline (Day 1)

Number of participants categorized by demographic characteristics including - health insurance coverage (yes, no), employment status (full time, part-time, housewife, not working, other, retired, self-employment), cigarette smoking status (current smoker, ex-smoker, non-smoker, unknown) and alcohol consumption (current, former, never, unknown) has been presented.

Health insurance coverage, yes

Group	Value	95% CI
Participants With Lupus Nephritis	143

Health insurance coverage, no

Group	Value	95% CI
Participants With Lupus Nephritis	50

Employment status, full time

Group	Value	95% CI
Participants With Lupus Nephritis	88

Employment status, part-time

Group	Value	95% CI
Participants With Lupus Nephritis	3

Employment status, housewife

Group	Value	95% CI
Participants With Lupus Nephritis	30

Employment status, not working

Group	Value	95% CI
Participants With Lupus Nephritis	58

Employment status, other

Group	Value	95% CI
Participants With Lupus Nephritis	9

Employment status, retired

Group	Value	95% CI
Participants With Lupus Nephritis	4

Number of Participants With Active Clinical Manifestations of Lupus Nephritis Primary · Up to 12 months

The active clinical manifestations included pedal edema, serositis, hair loss, decreased urine output, malar rash, discoid rash, photosensitive rash, joint pain/arthritis, hypertension, oral ulcer, seizure, psychosis, proteinuria, microscopic hematuria, anemia, thrombocytopenia, renal failure, leukopenia, other (autoimmune hepatitis, raised Serum creatinine with estimated glomerular filtration rate \[eGFR\] 59 milliliters per minute \[ml/min\]/1.73 meter square \[m\^2\]). Participants may have more than 1 active clinical manifestations of Lupus Nephritis.

Pedal edema

Group	Value	95% CI
Participants With Lupus Nephritis	59

Serositis

Group	Value	95% CI
Participants With Lupus Nephritis	23

Hair loss

Group	Value	95% CI
Participants With Lupus Nephritis	46

Decreased urine output

Group	Value	95% CI
Participants With Lupus Nephritis	13

Malar rash

Group	Value	95% CI
Participants With Lupus Nephritis	32

Discoid rash

Group	Value	95% CI
Participants With Lupus Nephritis	17

Photosensitive rash

Group	Value	95% CI
Participants With Lupus Nephritis	25

Joint pain/arthritis

Group	Value	95% CI
Participants With Lupus Nephritis	94

Number of Participants With Comorbidities Primary · Up to 12 months

Participants with comorbidities (such as antiphospholipid syndrome/thrombotic microangiopathy, obesity, cardiovascular disease, diabetes) observed since the date of first diagnosis of lupus nephritis has been presented.

Group	Value	95% CI
Participants With Lupus Nephritis	134

Number of Participants With Severe Lupus Nephritis Primary · Up to 12 months

Severe lupus nephritis was defined as participants with Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score greater than or equal to (\>=) 10. SLEDAI-2K score was the sum of all 24 individual items from the SLEDAI-2K. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity.

Group	Value	95% CI
Participants With Lupus Nephritis	60

Number of Participants Categorized by Treatments for Lupus Nephritis Primary · At Baseline (Day 1)

Number of participants categorized by treatments for lupus nephritis including prednisone, chloroquine, hydroxychloroquine, azathioprine, belimumab, tacrolimus, cyclosporine, voclosporin, cyclophosphamide, mycophenolate mofetil, methotrexate, and rituximab has been presented. Participants may have received more than 1 treatment for lupus nephritis.

Prednisone

Group	Value	95% CI
Participants With Lupus Nephritis	152

Chloroquine

Group	Value	95% CI
Participants With Lupus Nephritis	2

Hydroxychloroquine

Group	Value	95% CI
Participants With Lupus Nephritis	185

Azathioprine

Group	Value	95% CI
Participants With Lupus Nephritis	81

Belimumab

Group	Value	95% CI
Participants With Lupus Nephritis	19

Tacrolimus

Group	Value	95% CI
Participants With Lupus Nephritis	26

Cyclosporine

Group	Value	95% CI
Participants With Lupus Nephritis	6

Voclosporin

Group	Value	95% CI
Participants With Lupus Nephritis	0

Short Form Health Survey (SF-36) Health-related Quality of Life Domain Score Primary · At Baseline (Day 1)

The 36-Item Short Form Health Survey (SF-36) is a 36-item Health-Related Quality of Life (HRQoL) questionnaire covering 8 health domains: physical functioning, Pain, Role limitations due to physical health, Role limitations due to emotional problems, emotional well-being, Social Functioning, energy/fatigue, and General Health. The individual question items are first summed for each item under the various sections. Then, those domain scores were weighted to a scale ranging between 0 to 100, where higher score represents better health. Individual domain scores have been presented.

Physical functioning

Group	Value	95% CI
Participants With Lupus Nephritis	67.6	± 26.9

Pain

Group	Value	95% CI
Participants With Lupus Nephritis	59.5	± 29

Role limitation due to physical health

Group	Value	95% CI
Participants With Lupus Nephritis	64.1	± 41.4

Role limitation due to emotional problems

Group	Value	95% CI
Participants With Lupus Nephritis	66.5	± 41.5

Emotional well-being

Group	Value	95% CI
Participants With Lupus Nephritis	67.9	± 21.9

Social functioning

Group	Value	95% CI
Participants With Lupus Nephritis	69.7	± 28.1

Energy/fatigue

Group	Value	95% CI
Participants With Lupus Nephritis	57.7	± 21.3

General health

Group	Value	95% CI
Participants With Lupus Nephritis	49.7	± 38.4

Number of Participants With Refractory Lupus Nephritis Secondary · Up to 12 months

Refractory systemic lupus nephritis was defined as inefficacy of cyclophosphamide, use of rituximab, splenectomy, or inefficacy of \>=2 immunosuppressives (methotrexate, leflunomide, abatacept, anti-tumor necrosis factor \[anti-TNF\], azathioprine, mycophenolate mofetil, and/or mycophenolic acid).

Group	Value	95% CI
Participants With Lupus Nephritis	33

Number of Participants With Abnormal Findings for Serological Markers Secondary · At 3, 6, 9 and 12 months

Number of participants with abnormal findings for serological markers (including anti-nuclear antibody, anti-double-stranded deoxyribonucleic acid \[dsDNA\] antibody and complement levels \[C3, C4\]) has been presented. Abnormal values were determined by the investigator.

Anti-nuclear antibody: at 3 months

Group	Value	95% CI
Participants With Lupus Nephritis	2

Anti-nuclear antibody: at 6 months

Group	Value	95% CI
Participants With Lupus Nephritis	0

Anti-nuclear antibody: at 9 months

Group	Value	95% CI
Participants With Lupus Nephritis	2

Anti-nuclear antibody: at 12 months

Group	Value	95% CI
Participants With Lupus Nephritis	3

Anti-dsDNA antibody: at 3 months

Group	Value	95% CI
Participants With Lupus Nephritis	52

Anti-dsDNA antibody: at 6 months

Group	Value	95% CI
Participants With Lupus Nephritis	55

Anti-dsDNA antibody: at 9 months

Group	Value	95% CI
Participants With Lupus Nephritis	46

Anti-dsDNA antibody: at 12 months

Group	Value	95% CI
Participants With Lupus Nephritis	56

Number of Participants With Renal Remission That Were Associated With Clinical Factors, Biomarkers, and Treatments Secondary · Up to 12 months

Renal remission was defined as proteinuria of \<0.7 grams per day (g/d) or \<0.5g/d or at physicians' discretion. Number of participants with renal remission that were associated with clinical factors, biomarkers, and treatments has been presented.

Group	Value	95% CI
Participants With Lupus Nephritis	123

Percent Change From Baseline in SF-36 Scores for Each Health Domain:Physical Functioning, Pain, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problem, Emotional Well-being, Social Functioning, Energy/Fatigue and General Health Secondary · Baseline (Day 1) and at 12 months

The 36-Item Short Form Health Survey (SF-36) is a 36-item HRQoL questionnaire covering 8 health domains: physical functioning, pain, role limitations due to physical health, role limitations due to emotional problems, emotional well-being, social functioning, energy/fatigue, and general Health. The individual question items are first summed for each item under the various sections. Then, those domain scores were weighted to a scale ranging between 0 to 100, where higher score represents better health. Baseline was considered as Day 1. Change from Baseline was calculated by subtracting Baseline

Physical functioning

Group	Value	95% CI
Participants With Lupus Nephritis	23.7	± 182.5

Pain

Group	Value	95% CI
Participants With Lupus Nephritis	29	± 126.4

Role limitations due to physical health

Group	Value	95% CI
Participants With Lupus Nephritis	1.4	± 79.4

Role limitations due to emotional problems

Group	Value	95% CI
Participants With Lupus Nephritis	0.9	± 69.1

Emotional well-being

Group	Value	95% CI
Participants With Lupus Nephritis	6.6	± 63.4

Social functioning

Group	Value	95% CI
Participants With Lupus Nephritis	13.4	± 68.7

Energy/fatigue

Group	Value	95% CI
Participants With Lupus Nephritis	11.1	± 63.9

General health

Group	Value	95% CI
Participants With Lupus Nephritis	-2.8	± 40.2

Number of Participants With Hospitalizations and Intensive Care Unit (ICU) Hospitalizations Secondary · Up to 12 months

Number of participants with hospitalizations and ICU hospitalizations has been presented.

Participants with hospitalizations

Group	Value	95% CI
Participants With Lupus Nephritis	14

Participants with ICU hospitalizations

Group	Value	95% CI
Participants With Lupus Nephritis	1

Direct Medical Costs Associated With Lupus Nephritis Management Secondary · Up to 12 months

The direct medical costs of hospitalization and ICU hospitalization per participant associated with lupus nephritis management in United States dollars (USD) of United Arab Emirates (UAE), Kuwait, Qatar, and Oman were analyzed. Costs are described in local currency of each country and converted in USD dollars using the average exchange rate for each local currency versus USD in 2023. Direct medical costs associated with lupus nephritis management have been reported as USD.

Hospitalizations: UAE

Group	Value	95% CI
Participants With Lupus Nephritis	517	± 193.9

ICU hospitalizations: UAE

Group	Value	95% CI
Participants With Lupus Nephritis	141.6	± NA

Hospitalizations: Oman

Group	Value	95% CI
Participants With Lupus Nephritis	467.6	± 338.7

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality and serious adverse events were collected up to 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Lupus Nephritis

Serious: 5/193 (3%)

Deaths: 1/193

Serious adverse events (13 terms)

Reaction	System	Participants With Lupus Ne…
Vomiting	Gastrointestinal disorders	—
Palpitations	Cardiac disorders	—
Cardiac arrest	Cardiac disorders	—
Abdominal pain	Gastrointestinal disorders	—
Pyrexia	General disorders	—
COVID-19 virus test positive	Infections and infestations	—
SLE	Immune system disorders	—
Dyspnoea	Immune system disorders	—
Influenzal pneumonia	Respiratory, thoracic and mediastinal disorders	—
Respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—
Knee pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Vomiting, Palpitations, Cardiac arrest, Abdominal pain, Pyrexia, COVID-19 virus test positive, SLE, Dyspnoea.

Data from ClinicalTrials.gov NCT04971590 adverse events section.

Sponsor's own description

This is a multicenter prospective study to assess clinical characteristics, demographics, treatment and health-related quality of life (HRQoL) of lupus nephritis (LN) participants across 5 Gulf countries (United Arab Emirates \[UAE\], Qatar, Bahrain, Kuwait and Oman).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Literature review of lupus nephritis From the Arabian Gulf region.
Al-Shujairi A, Elbadawi F, Al-Saleh J, Hamouda M, et al · · 2023 · cited 9× · PMID 36331103 · DOI 10.1177/09612033221137248
LUNELORD: A descriptive, prospective study on the demographics, disease characteristics and health-related quality of life of patients with LUpus NEphritis and long-term ORgan damage in rheumatology clinics in the Arabian Gulf.
Al-Saleh J, Elbadawi F, Namas R, Elarabi M, et al · · 2026 · PMID 41866958 · DOI 10.1177/09612033261432164

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04971590 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 22 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04971590.

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