SMILE

Condition: Incomplete lupus erythematosus

Eligibility

Key Inclusion Criteria

  • 15-49 years old
  • Anti-nuclear antibody titer of 1:80 or higher
  • Must have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics classification criteria

Key Exclusion Criteria

  • Meets classification criteria for systemic lupus erythematosus at Visit 1
  • Diagnosed with another autoimmune disorder other than autoimmune thyroid conditions
  • Has fibromyalgia
  • Has taken hydroxychloroquine in the past

Full Study Name

Study of Anti-Malarials in Incomplete Lupus Erythematosus (IRB no. 43246)

Summary

The purpose of this study is to evaluate the effectiveness of a drug called hydroxychloroquine (HCQ) in individuals with incomplete lupus erythematosus (ILE). Systemic lupus erythematosus (SLE) is a disease in which the body's immune system mistakenly attacks healthy tissue. Patients diagnosed with SLE have at least four features that are characteristic of the disease. Individuals with ILE have only a few of the clinical or laboratory findings that are used to diagnose SLE. Researchers aim to determine whether HCQ can slow the development of SLE in ILE patients.

Participants will be randomly assigned to one of two groups. Group 1 will receive hydroxychloroquine, and Group 2 will receive placebo (inactive substance). HCQ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of SLE and other conditions, but it is not approved by the FDA for slowing the development of SLE in individuals who have ILE.

Phase

Phase II

Principal Investigator

Mariko Ishimori, MD

Contact
Bonnie Paul
Phone: 310-423-2422
Email: bonnie.paul@cshs.org