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7 Study Matches

Study of Antimalarials in Incomplete Lupus Erythematosus (SMILE)

This is a study to test whether a widely-used drug, hydroxychloroquine, might slow the progression of lupus like features in individuals who are at high risk for developing systemic lupus erythematosus. This will be measured by the accumulation of clinical and laboratory features of lupus. The study will randomize subjects to the active drug, hydroxychloroquine, or placebo, with an equal chance of receiving either treatment. The study treatment lasts approximately 2 years with visits approximately every 3 months.

Visits occur every 3 months for 2 years, Vitals signs and blood draws will occur at every visit.

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

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All
This study is NOT accepting healthy volunteers
NCT03030118
STUDY00003506
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Inclusion Criteria:
Positive for ANA (antinuclear antibodies)
Age 18 to 49 years, inclusive
Have never taken hydroxychloroquine

Exclusion Criteria:
Previous use of immunosuppressive drugs
Diagnosis of systemic lupus erythematosus
Arthritis & Rheumatic Diseases
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Hershey, PA ,

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TOEVALUATE THE EFFICACY AND SAFETY OFDAPIROLIZUMAB PEGOL IN STUDY PARTICIPANTS WITHMODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUSERYTHEMATOSUS

A randomized placebo-controlled study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

There is up to 15 visits over the course of 54 weeks. Lab samples will be collected, medication will be administered.

amount varies based on visits completed

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-0003, ext=283833
Medicine: Rheumatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT04294667
STUDY00017186
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Inclusion Criteria:
≥16 years of age
≥40kg and ≤160kg
diagnosis of Systemic lupus erythematosus (SLE)

Exclusion Criteria:
pregnancy
history of chronic alcohol or drug abuse
known history of allergic reaction to the drug
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

SNAC Study

This is a multi center clinical trial to test the efficacy of N-acetylcysteine for treatment of patients with active systemic lupus Erythematosus. Healthy control subjects who do not receive treatment are also recruited to serve as controls for the laboratory assays.

This is a clinical trial to be carried out in patients who have systemic lupus erythematosus. Participants will be asked to attend seven study visits over a period of 13 months. After an initial period where it will be determined that the patient can tolerate the medication, N-acetyl cysteine, then there will be a three-month double blind phase where the participant receives either the active treatment or a placebo. At each visit the participant will be asked to complete several questionnaires and blood and urine samples will be obtained. Healthy control individuals will be also enrolled for blood samples only; not for any treatment intervention.

$20 per visit completed

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT00775476
SITE00001115
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Inclusion Criteria:
Diagnosis of Systemic Lupus Erythematosus
Age 18 years or older
On stable medications
Experiencing flare of disease

Exclusion Criteria:
pregnant or lactating
regular daily use of Tylenol (acetaminophen)
active chronic infections
current treatment with cyclophosphamide or rituximab
current use of anti-oxidants
Arthritis & Rheumatic Diseases
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A PHASE III, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, NON-INFERIORITY, MULTI-CENTER STUDY OF THE EFFECTS OF STOPPING HYDROXYCHLOROQUINE IN ELDERLY LUPUS DISEASE

This trial will address the safety of withdrawing hydroxychloroquine (HCQ) in patients with systemic lupus erythematous who are 60 years of age or older. In this older population the benefits of HCQ are expected to decrease since disease activity decreases with advancing age. The study will test whether HCQ can be safely discontinued in stable/quiescent patients.

Participants will be in this study for about 1 year, during which time they will come to 7 visits in the research clinic. The first visit will take up to 2 hours and will include blood and urine sampling and completion of self-assessment questionnaires. Subsequent visits will take up to 1 hour. Participants will be randomized to receive either the active drug hydroxychloroquine or placebo. The treatment will be blinded to both the participant and the investigator. Diaries will be requested in which the participant keeps track of dosing of the study medication.

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05799378
SITE00001380
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Inclusion Criteria:
Have a diagnosis of systemic lupus
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares

Exclusion Criteria:
abnormal eye exam related to use of hydroxychloroquine
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Infectious Diseases & Immune System, Arthritis & Rheumatic Diseases
Not applicable
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Hershey, PA ,

A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil alone or with Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment

Treatment of Systemic Lupus with mycophenolate mofetil alone or with voclosporin

There will be 16 visit over a years time, physical exam, blood work, ECG, questionnaires

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-0003, ext=283833
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05306873
SITE00001147
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Inclusion Criteria:
18 years and older
Systemic Lupus

Exclusion Criteria:
Pregnant or breast feeding
Arthritis & Rheumatic Diseases
Approved drug(s)
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Hershey, PA ,

VIBRANT: VIB4920 for Active Lupus Nephritis

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

Yes
 

Nancy Olsen
Peri Newman - at pnewman@pennstatehealth.psu.edu or 717-531-0003, ext=287327
Medicine: Rheumatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05201469
SITE00001277
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Inclusion Criteria:
Lupus nephritis
Systemic lupus erythematosus

Exclusion Criteria:
Pregnant
Transplant
Kidney & Urinary System, Arthritis & Rheumatic Diseases, Muscle & Bone
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Mechanisms of New-Onset Autoimmunity-Longitudinal Immune Systems Analysis

The purpose of this study is to investigate why some individuals who have a few findings of autoimmunity eventually develop a condition such as systemic lupus erythematosus (SLE). In addition to stored biosamples from the SMILE clinical trial, new samples will be collected from persons with findings such as lab tests that are suggestive of lupus with an emphasis on recruitment of individuals ofnon-European ancestry, who were under-represented in the previous clinical trial.

Participants in this study will answer questions about their health and have a short physical exam performed on them. They will provide a blood and urine sample. These procedures will be repeated every twelve months for three years (a total of four times). Both routine and experimental tests will be performed on the blood and urine samples. Genetic studies will be done to help understand the risk of developing lupus.

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
SITE00001350
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Inclusion Criteria:
age 15 to 49 years inclusive
positive ANA test of at least 1:80
Have one or more additional features of lupus
Able to give assent or consent.

Exclusion Criteria:
Current or past use of hydroxychloroquine.
Current or past use of immunosuppressants
Have a diagnosis of another autoimmune disease, other than autoimmune thyroid disease.
Arthritis & Rheumatic Diseases
Not applicable
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Study Locations

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Hershey, PA ,