Study of Anti-Malarials in Incomplete Lupus Erythematosus

Prior treatment

• The subject has previously been or is currently being treated with oral antimalarial agents including hydroxychloroquine, chloroquine, or quinacrine.
• The subject is currently or has been treated with immunosuppressive, immune modifying, or cytotoxic medications as listed in Section 7.2.
• Use of any investigational agent within the preceding 12 months.
• The subject has other contraindications to treatment with hydroxychloroquine including pre-existing ocular disease, hepatic impairment, psoriasis, porphyria, or allergy to the drug or class.
• Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of prednisone per day, or equivalent, or a change in corticosteroid dose within the 3 months prior to Visit 1.
• Starting, stopping, or changing the dose of over the counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) in the three months prior to Visit 1.

Other illness

• The subject has been diagnosed with another autoimmune disorder, other than autoimmune thyroid conditions.
• History of primary immunodeficiency.
• Active bacterial, viral, fungal, or opportunistic infection.
• Evidence of infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
• Concomitant malignancy or history of malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Other

• The subject meets the 2012 SLICC classification criteria for SLE at Visit 1 (i.e., ANA plus 3 other criteria, or ANA plus biopsy-proven lupus nephritis).
• The subject has fibromyalgia, based on clinical history and exam.
• The subject has significant findings on ophthalmological examination that, in the opinion of the examining Ophthalmologist, prevent safe use of hydroxychloroquine.
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Inability to comply with the study visit schedule and procedures.

• Between 15 and 49 years of age, inclusive, at Visit 1.
• Anti-nuclear antibody (ANA) titer of 1:80, or greater, as determined by immunofluorescence assay (IFA).
• Participants must have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.