Clinical trials: Systemic Autoimmune Diseases
Lupus Erythematosus, Systemic
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
- Trial name
- NCT01127321
- Testing
- MEDI-570 0.03 MG, MEDI-570 0.1 MG, MEDI-570 0.3 MG
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 44 people
- Sponsor
- MedImmune LLC
Still's Disease, Adult-Onset, Still's Disease, Juvenile-Onset
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic…
- Trial name
- anaSTILLs (NCT03265132)
- Testing
- anakinra
- Where
- 39 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Swedish Orphan Biovitrum
Lupus Erythematosus, Systemic
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
- Trial name
- NCT01753193
- Testing
- Anifrolumab
- Where
- 57 sites in United States, Brazil and 11 more
- Volunteers
- 218 people
- Sponsor
- MedImmune LLC
Systemic Lupus Erythematosus
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and…
- Trial name
- SABLE (NCT01729455)
- Testing
- Benlysta, Standard of Care (SoC) Therapy
- Where
- 179 sites in United States, Argentina and 11 more
- Volunteers
- 3,138 people
- Sponsor
- GlaxoSmithKline
Lupus Nephritis
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).
- Trial name
- NCT03943147
- Testing
- BMS-986165, Mycophenolate Mofetil
- Where
- 100 sites in United States, Australia and 14 more
- Volunteers
- 16 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
- Trial name
- NCT00739050
- Testing
- simvastatin
- Volunteers
- 4 people
- Sponsor
- Organon and Co
Systemic Lupus Erythematosus, SLE
Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
- Trial name
- ALE06 (NCT01946880)
- Testing
- Mycophenolate Mofetil, Hydroxychloroquine or Chloroquine, Prednisone
- Where
- 19 sites in United States
- Volunteers
- 102 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lupus Nephritis
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis.
- Trial name
- NCT02081183
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Maintenance Phase, Cyclophosphamide, Induction Phase
- Where
- 2 sites in Venezuela
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Systemic Juvenile Idiopathic Arthritis With Active Flare
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.
- Trial name
- β-SPECIFIC 2 (NCT00889863)
- Testing
- canakinumab
- Where
- 73 sites in United States, Argentina and 17 more
- Volunteers
- 177 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).
- Trial name
- TULIP-LN1 (NCT02547922)
- Testing
- Anifrolumab
- Where
- 80 sites in United States, Argentina and 15 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Lupus Erythematosus, Systemic
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin).
- Trial name
- NCT02953821
- Testing
- Acthar Gel
- Where
- 39 sites in United States, Argentina and 3 more
- Volunteers
- 172 people
- Sponsor
- Mallinckrodt
Systemic Lupus Erythematosus
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
- Trial name
- NCT01031836
- Testing
- MEDI-545, MEDI-545 600
- Where
- 7 sites in Japan
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Lupus Nephritis
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis.
This study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus…
- Trial name
- NCT03610516
- Testing
- CFZ533
- Where
- 21 sites in Argentina, China and 8 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Lupus Nephritis, Lupus Erythematosus, Systemic
Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is…
- Trial name
- ACCESS (NCT00774852)
- Testing
- abatacept, cyclophosphamide, azathioprine
- Where
- 23 sites in United States, Mexico
- Volunteers
- 137 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cutaneous Lupus, Systemic Lupus Erythematosus
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA administrated to young adults (18-45…
- Trial name
- NCT03288324
- Testing
- Tofacitinib
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Systemic Lupus Erythematosus (SLE)
Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease
This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous…
- Trial name
- NCT01753401
- Testing
- Acthar, Steroid Drug
- Where
- 22 sites in United States
- Volunteers
- 38 people
- Sponsor
- Mallinckrodt
Systemic Lupus Erythematosus
Study of Anti-Malarials in Incomplete Lupus Erythematosus
This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation…
- Trial name
- SMILE (NCT03030118)
- Testing
- Hydroxychloroquine
- Where
- 7 sites in United States
- Volunteers
- 187 people
- Sponsor
- Milton S. Hershey Medical Center
Systemic Lupus Erythematosus, Systemic Sclerosis
Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors)…
- Trial name
- NCT00684255
- Testing
- Reduced Intensity Allogeneic Transplant, Fludarabine, Busulfan
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- New York Medical College
Lupus Nephritis
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in…
- Trial name
- NCT00377637
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Azathioprine
- Where
- 108 sites in United States, Argentina and 15 more
- Volunteers
- 370 people
- Sponsor
- Hoffmann-La Roche