Condition: Rheumatoid arthritis
Key Inclusion Criteria
- At least 18 years old at screening visit
- Elevation of anti-CCP3≥40 units at screening
- Able and willing to give written informed consent and comply with requirements of the study
Key Exclusion Criteria
- Medical history or current evidence of inflammatory arthritis (IA) and/or rheumatic disease and immunologic diseases that may be associated with IA
- Prior or current systemic treatment with disease-modifying antirheumatic drugs, immunomodulatory agents, or glucocorticoids for IA or other rheumatic/immunologic diseases
- Tetracycline class antibiotic use for autoimmune conditions, taken within 12 months prior to screening
Full Study Name
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (ARA08) (IRB no. 42472)
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. RA is a disease in which the immune system attacks the joints, leading to joint inflammation and damage. 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.
HCQ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of various conditions, but it is not currently approved for the prevention of RA; its use in this study is investigational. Researchers believe that the use of HCQ in patients who have elevations of anti-CCP without joint inflammation may help prevent the future onset of RA.