1. | Subject meets the 2012 Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus at Visit 1 (i.e., ANA plus three other criteria or ANA plus biopsy-proven lupus nephritis) |
2. | Subject has been diagnosed with another autoimmune disorder, other than autoimmune thyroid conditions |
3. | Subject has fibromyalgia, based on clinical history and examination |
4. | Subject has previously been or is currently being treated with oral antimalarial agents including hydroxychloroquine, chloroquine or quinacrine |
5. | Subject is currently or has been treated with immunosuppressive, immune-modifying or cytotoxic medications as detailed in the protocol |
6. | Use of any investigational agent within the preceding 12 months |
7. | History of primary immunodeficiency |
8. | Active bacterial, viral, fungal or opportunistic infection |
9. | Evidence of infection with human immunodeficiency virus, hepatitis B or hepatitis C |
10. | 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 |
11. | Subject has significant findings on ophthalmological examination that, in the opinion of the examining ophthalmologist, prevent safe use of hydroxychloroquine. |
12. | Subject has other contraindications to treatment with hydroxychloroquine, including preexisting ocular disease, hepatic impairment, psoriasis, porphyria, or allergy to the drug or class |
13. | Comorbidities requiring systemic corticosteroid therapy > 10 mg of prednisone per day, or equivalent, or a change in corticosteroid dose within the 3 months prior to Visit 1 |
14. | Pregnant, breastfeeding or unwilling to practice birth control during participation in the study |
15. | 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 |
16. | Inability to comply with the study visit schedule and procedures |