Rheumatic Clinical Trials

Providing new and innovative clinical trials to replace old therapies is our priority. The patient population at Cedars-Sinai, as well as the cooperation of the 30 attending rheumatologists, is positioned to be at the forefront of innovative trials that will benefit our patients and bring new therapies to the practicing physician.

Questions? See the Clinical Trials FAQs.

Condition:
Granulomatosis with polyangiitis

Participants Must:
Be best characterized as granulomatosis with polyangiitis (GPA) and not microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis and must have met at least 2 of the 5 modified American College of Rheumatology classification criteria for GPA; be at least 15 years old; be willing to use an effective means of birth control while receiving treatment.

Summary:
This study focuses on patients who have granulomatosis with polyangiitis (also known as Wegener's or GPA) and who currently have active disease that is non-severe and relapsing (having a recurrence of the disease). GPA is an illness characterized by inflammation of blood vessels (vasculitis). The purpose of the study is to determine the effectiveness and safety of a medication called abatacept. The current treatment for GPA is a combination of drugs, including prednisone (steroid medication) and other immunosuppressant medications. Although prednisone is effective, it is associated with side effects and does not prevent the occurrence of disease relapses.

Condition:
Arthritis

Participants Must:
Be patients with rheumatic diseases who are identified by physicians in the Cedars-Sinai Division of Rheumatology

Summary:
The purpose of this research registry is to identify patients with rheumatic diseases who are interested in learning about current and future studies in which they may be eligible to participate. The registry is designed to assist the recruitment phase of research efforts. Individuals who decide to participate in the Arthritis Patient Registry will have their name, contact information, diagnosis and other information from medical records entered into a database.

Condition:
Systemic lupus erythematosus

Participants Must:

Be 12 years old or older at time of consent; have diagnosis that satisfies the 1982 American College of Rheumatology's criteria for the classification systemic lupus erythematosus as revised in 1997.

Summary:
The purpose of this study is to increase knowledge about lupus and its causes, and to improve treatment and care. The study will collect blood samples, which will be used in future studies to understand biomarkers and genetic and immune pathways that are important in lupus. The blood samples will also help enable the development of new drugs or tests for lupus patients. Clinical data, DNA and RNA will also be collected.

Condition:
Systemic lupus erythematosus

Participants Must:
Be 18-65 years old; have historical presence of at least 4 of 11 of the American College of Rheumatology classification criteria for systemic lupus erythematosus; have clinically active systemic lupus erythematosus.

Summary:
This study focuses on individuals who have moderate to severely active systemic lupus erythematosus (SLE). The purpose of the study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with active SLE. Researchers aim to determine whether patients receiving an MSC infusion in addition to standard of care for SLE respond better than those receiving placebo infusion.

Condition:
Lupus heart disease

Participants Must:

Be adult female lupus patients who are 30-55 years old with signs or symptoms concerning for ischemia and meeting criteria for lupus; have ability to give informed consent.

Summary:
This study focuses on female lupus patients with symptoms of cardiac ischemia. The purpose of the study is to define the pathways of heart disease or cardiovascular disease in patients with lupus. The study will combine cardiac imaging techniques with analysis of immune cells from lupus patients to potentially identify a cure and improve quality of life for individuals who are affected by the disease.

Condition:
Rheumatoid arthritis

Participants Must:
Be at least 18 years old; have classification of rheumatoid arthritis (RA) by American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) 2010 and/or 1987 Criteria; have evidence of ongoing RA-related disease activity with >2 swollen joints within 3 months of surgery.

Summary:
This study focuses on individuals who have developed active rheumatoid arthritis (RA) with at least two actively inflamed (clinically tender and swollen) joints. Inflammation of the membrane surrounding the joints is a condition known as "synovitis." The study will examine tissue and blood from individuals with synovitis at various stages of disease. The purpose of the study is to better understand these stages in the course of disease progression and determine whether they are reflected in molecular and cellular signatures (identities) of tissues and blood.

Condition:
Incomplete lupus erythematosus

Participants Must:
Be 15-49 years old; have anti-nuclear antibody titer of 1:80 or higher; have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics classification criteria

Summary:
The purpose of this study is to evaluate the effectiveness of a drug called hydroxychloroquine (HCQ) in individuals with incomplete lupus erythematosus (ILE). Systemic lupus erythematosus (SLE) is a disease in which the body's immune system mistakenly attacks healthy tissue. Patients diagnosed with SLE have at least four features that are characteristic of the disease. Individuals with ILE have only a few of the clinical or laboratory findings that are used to diagnose SLE. Researchers aim to determine whether HCQ can slow the development of SLE in ILE patients.

Condition:
Spondyloarthritis

Participants Must:

  • (Affected Participants) Be at least 12 years old at time of consent; have diagnosis that satisfies the Assessment of SpondyloArthritis International Society's criteria for the classification of peripheral or axial spondyloarthritis
  • (Non-Affected Participants) Be a non-affected or affected first degree relative; be at least 12 years old at time of consent

Summary:
The purpose of this study is to increase knowledge about spondyloarthropathies and their outcomes, as well as to better understand the causes and improve treatment and care. Spondyloarthropathies are a group of related joint diseases that share common clinical features, generally involving the sacroiliac joints (where the low back connects to the pelvis) and/or areas around joints where ligaments and tendons attach to bone. The study will collect information to create a clinical repository, which will make ongoing research in spondyloarthritis possible at Cedars-Sinai.

Condition:
Rheumatoid arthritis

Participants Must:

Be at least 18 years old at screening visit; have elevation of anti-CCP3≥40 units at screening; be able and willing to give written informed consent and comply with requirements of the study.

Summary:
This study focuses on patients who have an abnormal blood marker called anti-cyclic citrullinated peptide (anti-CCP), which is an antibody that indicates an individual may be at increased risk for developing rheumatoid arthritis (RA) in the future. The purpose of the study is to determine whether a drug called hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of RA in individuals who have elevations of anti-CCP.