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Monoclonal Antibodies

Belimumab for Early Lupus

Phase 4
Recruiting
Led By Cynthia Aranow, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of SLE per current ACR classification criteria
Concomitant treatment with hydroxychloroquine unless documented inability to tolerate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights

Study Summary

This trial will study the effects of the drug belimumab on patients with early lupus. Half the patients will receive the drug, while the other half will receive a placebo. The trial will last two years.

Who is the study for?
This trial is for individuals diagnosed with early lupus (within the last 2 years), who have mild to moderate disease activity. Participants must be ANA and anti-ds DNA antibody positive, on stable medication doses, able to consent, and use birth control if of reproductive potential. Exclusions include severe organ dysfunction, certain infections or immunodeficiencies, recent drug abuse, pregnancy/lactation, psychiatric disorders affecting participation.Check my eligibility
What is being tested?
The study tests Belimumab's effects on patients with early lupus over two years. In year one, participants are randomly assigned to receive either Belimumab or a placebo. In the second year, those initially given Belimumab may continue it or switch to a placebo. The focus is on clinical outcomes and immune system responses.See study design
What are the potential side effects?
While not specified here, common side effects of Belimumab can include nausea, diarrhea, fever; some may experience infusion reactions like pain or swelling at injection site. Serious but rare risks involve allergic reactions and possible impact on mental health such as depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lupus according to ACR criteria.
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I am taking hydroxychloroquine or cannot tolerate it.
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I have tested positive for anti-ds DNA antibodies.
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My ANA test result is positive with a high level.
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I was diagnosed with lupus less than 2 years ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Cardiovascular biomarkers
Complement levels
Damage
+21 more

Side effects data

From 2017 Phase 3 trial • 106 Patients • NCT01663623
19%
Cough
13%
Upper respiratory tract infection
13%
Nausea
13%
Fatigue
11%
Nasopharyngitis
11%
Arthralgia
11%
Pyrexia
9%
Influenza
9%
Diarrhoea
9%
Vomiting
9%
Headache
9%
Rash
9%
Urinary tract infection
9%
Epistaxis
8%
Oropharyngeal pain
6%
Abdominal pain upper
6%
Back pain
6%
Hypertension
4%
Hypersensitivity
4%
Bursitis
2%
Ischaemic stroke
2%
Haemorrhagic stroke
2%
Neutropenic sepsis
2%
Lower respiratory tract infection
2%
Cellulitis
2%
Hip fracture
2%
Pneumothorax traumatic
2%
Post procedural discharge
2%
General physical health deterioration
2%
Basal cell carcinoma
2%
Plasma cell myeloma
2%
Chronic gastritis
2%
Cholangitis
2%
Hypercalcaemia
2%
Acute kidney injury
2%
Abdominal pain
2%
Neutropenia
2%
Thrombocytopenia
2%
Anaphylactic reaction
2%
Anal cancer
2%
Pneumomediastinum
2%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Belimumab 10 mg/kg

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Belimumab/PlaceboExperimental Treatment1 Intervention
Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 1 year and then placebo injections subcutaneously for 1 year.
Group II: BelimumabActive Control1 Intervention
Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 2 years
Group III: PlaceboPlacebo Group1 Intervention
Subjects in this arm will receive placebo for self administration subcutaneously weekly for 2 years

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,903 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,748 Previous Clinical Trials
8,067,482 Total Patients Enrolled
Cynthia Aranow, MD5.01 ReviewsPrincipal Investigator - Feinstein Institute for Medical Research, Northwell Health
Northwell Health
5 Previous Clinical Trials
237 Total Patients Enrolled

Media Library

Belimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03543839 — Phase 4
Systemic Lupus Erythematosus Research Study Groups: Belimumab, Belimumab/Placebo, Placebo
Systemic Lupus Erythematosus Clinical Trial 2023: Belimumab Highlights & Side Effects. Trial Name: NCT03543839 — Phase 4
Belimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03543839 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enroll in this exploration?

"Affirmative. The information on clinicaltrials.gov shows that recruitment is still ongoing for this medical trial, which was initially published on September 15th 2020 and modified most recently in December 2nd 2021. This research seeks to include 30 patients at a single site."

Answered by AI

Has a comparable medical trial been conducted before this one?

"Currently, 17 trials for Belimumab/Placebo are taking place in 15 countries and 36 cities. Originally sponsored by Human Genome Sciences Inc., a GSK Company, the first trial launched in 2012 with 93 participants and successfully completed Phase 2 drug approval. Since then, 18359 studies have been conducted on the subject."

Answered by AI

Have any other research initiatives compared Belimumab to a placebo?

"At present, 17 studies assessing the effects of Belimumab/Placebo are ongoing with two in Phase 3. These clinical trials are being conducted at 88 different sites across Beijing and beyond."

Answered by AI

What is the aggregate size of the participants in this research project?

"Confirmed. Information posted on clinicaltrials.gov affirms that this research endeavour is still actively seeking participants, which was initially launched on September 15th 2020 and most recently updated December 2nd 2021. A total of 30 people are required to be recruited from a single medical centre."

Answered by AI

What potential risks exist with Belimumab/Placebo use?

"The safety of Belimumab/Placebo has been assessed as a 3 on the 1 to 3 scale, indicating that it is an approved treatment due to its Phase 4 clinical trial status."

Answered by AI
~12 spots leftby Aug 2026