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Table 2 Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE) exclusion criteria

From: Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial

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
  1. ANA antinuclear antibody