Clinical Trial: Study of Anti-Malarials in Incomplete Lupus Erythematosus
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Study of Anti-Malarials in Incomplete Lupus Erythematosus
Brief Summary: This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation of disease features. Effects on clinical progression of symptoms, patient-reported outcomes and changes in the immune markers of response will be measured and toxicity of the treatment will be assessed. This trial is a first step in testing a prevention strategy for lupus.
Detailed Summary:
Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidenced-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE). We propose to treat ILE patients with hydroxychloroquine (HCQ) in the "Study of Anti-Malarials in Incomplete Lupus Erythematosus" or SMILE trial. The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE.
The major secondary objectives are to determine whether HCQ treatment: (1) lessens lupus disease activity as measured by standard scoring indices; (2) improves patient reported outcomes (3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines and (4) has an acceptable toxicity profile. The specific aims of this proposal are:
- To carry out a double-blind, placebo-controlled, multicenter, randomized trial of HCQ vs. placebo in patients with ILE. The study tests the hypothesis that early use of HCQ can modify disease features so that accumulation of abnormalities leading to a classification of SLE can be significantly slowed.
- To determine effects of HCQ on disease activity a
Sponsor: Milton S. Hershey Medical Center
Current Primary Outcome: SLICC Score [ Time Frame: Measured every 12 weeks for 96 weeks. ]
The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Disease Progression [ Time Frame: Measured every 12 weeks for 96 weeks ]The time to progression from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.
- Disease Activity [ Time Frame: Measured every 12 weeks for 96 weeks ]Disease activity measured by the SLE Disease Activity Index
- Disease Activity [ Time Frame: Measured every 12 weeks for 96 weeks ]Disease activity measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index
- Patient reported outcomes [ Time Frame: Measured every 12 weeks for 96 weeks ]The PROMIS 29 Adult Profile
- Patient reported outcomes [ Time Frame: Measured every 12 weeks for 96 weeks ]Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items
- Patient reported outcomes [ Time Frame: Measured every 12 weeks for 96 weeks ]Patient Global Visual Analogue Scale
- Immunologic mediators [ Time Frame: Measured every 12 weeks for 96 weeks ]Serum levels of autoantibodies,cytokines and chemokines will be measured.
- Ophthalmologic toxicity [ Time Frame: Measured after screening and prior to baseline and within 4 weeks after study completion ]Dilated fundoscopic examination
- Ophthalmologic toxicity [ Time Frame: Measured after screening and prior to baseline and within 4 weeks after study completion ]Spectral domain ocular coherence tomography
- Ophthalmologic toxicity [ Time Frame: Measured after screening and prior to baseline and within 4 weeks after study completion ]Humphrey visual field testing
Original Secondary Outcome: Same as current
Information By: Milton S. Hershey Medical Center
Dates:
Date Received: January 15, 2017
Date Started: July 1, 2017
Date Completion: January 2022
Last Updated: March 21, 2017
Last Verified: March 2017
- Disease Progression [ Time Frame: Measured every 12 weeks for 96 weeks ]
