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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.
Age 18 to 49 years, inclusive
Have never taken hydroxychloroquine
Diagnosis of systemic lupus erythematosus
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
≥40kg and ≤160kg
diagnosis of Systemic lupus erythematosus (SLE)
history of chronic alcohol or drug abuse
known history of allergic reaction to the drug
Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry
The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry was first established in 2010 to advance alliance infrastructure,facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. Continuation of the CARRA Registry as described in the protocol attached to this IRB submission will support data collection onpatients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressingquestions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinicaland Data Coordinating Center (CDCC) for this protocol.
In addition to allowing the researchers to collect data on you from your medical record, we will ask you and your parents/caregivers to complete a short survey that takes about 15 minutes to completeThe research team will follow up every 6 months by reviewing your medical record and asking you and your parents/caregivers to complete a short survey that takes about 15 minutes to complete.If you agree to take part, you will be in the study for 10 or more years.
Onset prior to age 19 years for all other rheumatic diseases
Willing to participate in a registry you will be followed during your treatment and have information about you disease and treatment collected.
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
Age 18 years or older
On stable medications
Experiencing flare of disease
regular daily use of Tylenol (acetaminophen)
active chronic infections
current treatment with cyclophosphamide or rituximab
current use of anti-oxidants
Physical Therapists Role in Promoting Physical Activity for People with Chronic Physical Disabilities
We plan to conduct a qualitative study exploring perspectives of physical therapists and people with disability regarding physical activity promotion
Fluent in english
Individual with a physical disability (eg. limb amputation, spinal cord injury, spinabifida, cerebralpalsy, arthritis, motor impairment)
Has participated in physical therapy in the last year
Does not speak fluent english
does not have a physical disability
Has not participated in physical activity in the last year
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.
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Couples' Daily Lives with Chronic Back Pain
The purpose of this study is to learn more about the daily experiences of people with back pain and their spouse/partner. Participants and their spouse/partner will be interviewed by video using a tablet computer every 6 months for 2 years and will be asked to complete daily surveys twice a day for 30 days using the provided tablet computer. The daily surveys will take about 5 to 10 minutes to complete. Questions for the interviews and daily surveys focus on physical symptoms, feelings, activities, and interactions.
Video interviews using a tablet computer every 6 months for 2 years. Complete daily surveys twice a day for 30 days using a tablet computer.
Experienced moderate or severe back pain for at least 3 months
Married or in a long-term relationship AND living with spouse or partner
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
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.
Systemic lupus erythematosus
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.
positive ANA test of at least 1:80
Have one or more additional features of lupus
Able to give assent or consent.
Current or past use of immunosuppressants
Have a diagnosis of another autoimmune disease, other than autoimmune thyroid disease.