Clinical Trials

Inclusion Criteria

• Able and willing to give written informed consent and comply with requirements of the study.
• Age ≥18 years-old at the screening visit.
• Elevation of autoantibody anti-cyclic citrullinated peptide (anti-CCP) defined by result of anti-CCP ≥40 units, at screening.

Exclusion Criteria:

• Medical history or current evidence of IA (any type) and/or rheumatic disease and immunologic diseases that may be associated with IA. These diseases include but are not limited to RA, SLE, seronegative spondyloarthropathies (including ankylosing spondylitis, psoriatic arthritis and reactive arthritis), inflammatory bowel disease (including Crohn’s and ulcerative colitis), Sjögren’s syndrome, scleroderma, polymyalgia rheumatica and vasculitis. Patients with mild/moderate crystalline arthropathies do not need to be excluded.
• Prior or current systemic treatment with DMARDs, immunomodulatory agents, or glucocorticoids for IA or other rheumatic or immunologic diseases.
• Tetracycline class antibiotic use for autoimmune conditions, taken within 12 months prior to screening. Note: If a tetracycline class antibiotic is used for non-autoimmune conditions, it should be stopped at Day 0/ Randomization visit.
• Systemic corticosteroid use for non-IA conditions taken 28 days prior to screening.
• A history of a chronic condition that in the opinion of the investigator is highly likely to require therapy with systemic corticosteroids (oral, intramuscular (IM) or intravenous (IV)) within the study period including but not limited to severe asthma and severe crystalline arthropathy.
• More than 3 local corticosteroid injections, including but not limited to intra-articular, epidural, and intra-bursal injections, during the 3 months prior to randomization.
• Women who are pregnant, breastfeeding or desire to become pregnant and/or breast feed within the duration of the 12-month treatment phase of the study.
• Women of childbearing potential not using or agreeing to use adequate birth control measures (e.g., total abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization, Depo-Provera, or hormonal implants) during the treatment phase of the study.
• Functional status of NY Heart Association (NYHA) Class III or higher at the screening visit.
• Medical history of cardiomyopathy, congestive heart failure, or significant cardiac conduction disorders.
• Medical history of chronic liver disease.
• Medical history of psoriasis (due to potential for increased risk for flare of skin disease) or porphyria.
• Medical history or serologic evidence at Screening of chronic infections including, but not limited to, human immunodeficiency virus (HIV), hepatitis B, and untreated hepatitis C.
  • Note: A subject who is Hepatitis C antibody positive will be eligible to participate in the study if he/she has documented treatment of Hepatitis C and documentation of negative hepatitis C viral load post- treatment.
• History of malignancy within the last 5 years, except for treated basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I.
• A history of alcohol or substance abuse within 1 year of randomization.
• Ideal or actual body weight ≤24.4 kg at screening.
• Any of the following laboratory abnormalities at the screening visit:
  •  Serum creatinine clearance < 50 ml/min (as calculated by the Cockcroft-Gault formula);
  •  Alanine Aminotransferase (ALT) > 2x the upper limit of normal (ULN);
  •  Aspartate Aminotransferase (AST) > 2x the upper limit of normal (ULN);
  •  INR ≥1.25 if not currently taking anticoagulation therapy;
  •  Total white blood count (WBC) < 3.0 x 109/L;
  •  Platelet count ≤150 x109/L;
  •  Hemoglobin < 11 g/dL;
  •  Absolute Neutrophil Count (ANC) < 2.0 x 109/L.
• Evidence of significant retinal disease upon eye examination during the screening period that in the opinion of the examiner would make identification of potential future retinal toxicity from HCQ difficult to evaluate.
  • Note: Retinal exam results may be applied to evaluations of subject eligibility for up to 6 months after the initial retinal exam.
• The physician may exclude, for any reason, any subject he/she does not believe would be a good study candidate.