<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03030118</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003506</org_study_id>
    <secondary_id>U01AR071077</secondary_id>
    <nct_id>NCT03030118</nct_id>
  </id_info>
  <brief_title>Study of Anti-Malarials in Incomplete Lupus Erythematosus</brief_title>
  <acronym>SMILE</acronym>
  <official_title>Study of Anti-Malarials in Incomplete Lupus Erythematosus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial&#xD;
      that is designed to test whether treating patients who are at risk for development of lupus&#xD;
      with hydroxychloroquine can slow accumulation of disease features. Effects on clinical&#xD;
      progression of symptoms, patient-reported outcomes and changes in the immune markers of&#xD;
      response will be measured and toxicity of the treatment will be assessed. This trial is a&#xD;
      first step in testing a prevention strategy for lupus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in&#xD;
      relatively young persons. Early diagnosis and treatment are essential to improving outcomes&#xD;
      for SLE patients. However, evidenced-based approaches to early treatment interventions and&#xD;
      the appropriate target population for these interventions are not available. We propose that&#xD;
      individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some&#xD;
      of the other features that are used to classify SLE, are at high risk of progressing to the&#xD;
      full systemic form of this disease. These individuals, who have significant levels of ANA&#xD;
      with 1 or 2 additional items from the lupus classification criteria, are considered to have&#xD;
      incomplete lupus erythematosus (ILE). We propose to treat ILE patients with&#xD;
      hydroxychloroquine (HCQ) in the &quot;Study of Anti-Malarials in Incomplete Lupus Erythematosus&quot;&#xD;
      or SMILE trial. The primary objective is to determine whether HCQ treatment can prevent&#xD;
      acquisition of additional clinical and immunologic features that define SLE.&#xD;
&#xD;
      The major secondary objectives are to determine whether HCQ treatment: (1) lessens lupus&#xD;
      disease activity as measured by standard scoring indices; (2) improves patient reported&#xD;
      outcomes (3) prevents accumulation of immunologic abnormalities including autoantibodies and&#xD;
      cytokines and (4) has an acceptable toxicity profile. The specific aims of this proposal are:&#xD;
&#xD;
        1. To carry out a double-blind, placebo-controlled, multicenter, randomized trial of HCQ&#xD;
           vs. placebo in patients with ILE. The study tests the hypothesis that early use of HCQ&#xD;
           can modify disease features so that accumulation of abnormalities leading to a&#xD;
           classification of SLE can be significantly slowed.&#xD;
&#xD;
        2. To determine effects of HCQ on disease activity and patient-reported outcomes in&#xD;
           patients with ILE.&#xD;
&#xD;
        3. To characterize the immunologic profile of HCQ in ILE-treated patients. Autoantibodies,&#xD;
           cytokines and chemokines will be measured on multiplex arrays for developing insights&#xD;
           into underlying mechanisms.&#xD;
&#xD;
        4. To quantitatively assess the incidence of ophthalmologic toxicity in HCQ-treated ILE&#xD;
           patients. All enrolled patients will have standardized ophthalmologic examinations&#xD;
           before and after study treatment. Recommendations for use and monitoring in this patient&#xD;
           population will be developed.&#xD;
&#xD;
      The SMILE trial will determine whether or not HCQ should be given to ILE patients, will&#xD;
      provide insights into the appropriate target population, and will propose candidate&#xD;
      biomarkers to guide treatment decisions. While not part of the Precision Medicine&#xD;
      Initiative®, SMILE is consistent with its goals. It will be the first step towards testing&#xD;
      the feasibility of disease prevention studies in SLE and will accumulate biological samples&#xD;
      in a repository that will be available to the lupus research community for further in-depth&#xD;
      mechanistic studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 28, 2017</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SLICC Score</measure>
    <time_frame>Measured every 12 weeks for 96 weeks.</time_frame>
    <description>The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Progression</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>The time to progression from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>Disease activity measured by the SLE Disease Activity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>Disease activity measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>The PROMIS 29 Adult Profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>Patient Global Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunologic mediators</measure>
    <time_frame>Measured every 12 weeks for 96 weeks</time_frame>
    <description>Serum levels of autoantibodies,cytokines and chemokines will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ophthalmologic toxicity</measure>
    <time_frame>Measured after screening and prior to baseline and within 4 weeks after study completion</time_frame>
    <description>Dilated fundoscopic examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ophthalmologic toxicity</measure>
    <time_frame>Measured after screening and prior to baseline and within 4 weeks after study completion</time_frame>
    <description>Spectral domain ocular coherence tomography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ophthalmologic toxicity</measure>
    <time_frame>Measured after screening and prior to baseline and within 4 weeks after study completion</time_frame>
    <description>Humphrey visual field testing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxychloroquine</intervention_name>
    <description>Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.</description>
    <arm_group_label>Hydroxychloroquine</arm_group_label>
    <other_name>Plaquenil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.</description>
    <arm_group_label>Placebo oral capsule</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 15 and 49 years of age, inclusive, at Visit 1.&#xD;
&#xD;
          2. Anti-nuclear antibody (ANA) titer of 1:80, or greater, as determined by&#xD;
             immunofluorescence assay (IFA).&#xD;
&#xD;
          3. Participants must have at least one (but not three or more) additional clinical or&#xD;
             laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics&#xD;
             (SLICC) classification criteria.&#xD;
&#xD;
          4. Written informed consent (and assent when applicable) obtained from subject or&#xD;
             subject's legal representative and ability for subject to comply with the requirements&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject meets the 2012 SLICC classification criteria for SLE at Visit 1 (i.e., ANA&#xD;
             plus 3 other criteria, or ANA plus biopsy-proven lupus nephritis).&#xD;
&#xD;
          2. The subject has been diagnosed with another autoimmune disorder, other than autoimmune&#xD;
             thyroid conditions.&#xD;
&#xD;
          3. The subject has fibromyalgia, based on clinical history and exam.&#xD;
&#xD;
          4. The subject has previously been or is currently being treated with oral antimalarial&#xD;
             agents including hydroxychloroquine, chloroquine, or quinacrine.&#xD;
&#xD;
          5. The subject is currently or has been treated with immunosuppressive, immune modifying,&#xD;
             or cytotoxic medications as listed in Section 7.2.&#xD;
&#xD;
          6. Use of any investigational agent within the preceding 12 months.&#xD;
&#xD;
          7. History of primary immunodeficiency.&#xD;
&#xD;
          8. Active bacterial, viral, fungal, or opportunistic infection.&#xD;
&#xD;
          9. Evidence of infection with human immunodeficiency virus (HIV), Hepatitis B, or&#xD;
             Hepatitis C.&#xD;
&#xD;
         10. Concomitant malignancy or history of malignancy with the exception of adequately&#xD;
             treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the&#xD;
             cervix.&#xD;
&#xD;
         11. The subject has significant findings on ophthalmological examination that, in the&#xD;
             opinion of the examining Ophthalmologist, prevent safe use of hydroxychloroquine.&#xD;
&#xD;
         12. The subject has other contraindications to treatment with hydroxychloroquine including&#xD;
             pre-existing ocular disease, hepatic impairment, psoriasis, porphyria, or allergy to&#xD;
             the drug or class.&#xD;
&#xD;
         13. Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of&#xD;
             prednisone per day, or equivalent, or a change in corticosteroid dose within the 3&#xD;
             months prior to Visit 1.&#xD;
&#xD;
         14. Starting, stopping, or changing the dose of over the counter or prescription&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs) in the three months prior to Visit 1.&#xD;
&#xD;
         15. Pregnant, breastfeeding, or unwilling to practice birth control during participation&#xD;
             in the study.&#xD;
&#xD;
         16. Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the patient or the quality of the data.&#xD;
&#xD;
         17. Inability to comply with the study visit schedule and procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy J Olsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State MS Hershey Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David R Karp, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Medical Research Foundation</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State MS Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ, Liao D, Olsen NJ. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1425-1429. doi: 10.1002/acr.23802.</citation>
    <PMID>30369087</PMID>
  </reference>
  <reference>
    <citation>Olsen NJ, James JA, Arriens C, Ishimori ML, Wallace DJ, Kamen DL, Chong BF, Liao D, Chinchilli VM, Karp DR. Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial. Trials. 2018 Dec 20;19(1):694. doi: 10.1186/s13063-018-3076-7.</citation>
    <PMID>30572906</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Nancy Olsen</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>hydroxychloroquine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03030118
org study id: STUDY00003506
secondary id: U01AR071077
nct id: NCT03030118
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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:

        1. 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.

        2. To determine effects of HCQ on disease activity and patient-reported outcomes in
           patients with ILE.

        3. To characterize the immunologic profile of HCQ in ILE-treated patients. Autoantibodies,
           cytokines and chemokines will be measured on multiplex arrays for developing insights
           into underlying mechanisms.

        4. To quantitatively assess the incidence of ophthalmologic toxicity in HCQ-treated ILE
           patients. All enrolled patients will have standardized ophthalmologic examinations
           before and after study treatment. Recommendations for use and monitoring in this patient
           population will be developed.

      The SMILE trial will determine whether or not HCQ should be given to ILE patients, will
      provide insights into the appropriate target population, and will propose candidate
      biomarkers to guide treatment decisions. While not part of the Precision Medicine
      Initiative®, SMILE is consistent with its goals. It will be the first step towards testing
      the feasibility of disease prevention studies in SLE and will accumulate biological samples
      in a repository that will be available to the lupus research community for further in-depth
      mechanistic studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: SLICC Score
time frame: Measured every 12 weeks for 96 weeks.
description: The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus
measure: Disease Progression
time frame: Measured every 12 weeks for 96 weeks
description: The time to progression from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.
measure: Disease Activity
time frame: Measured every 12 weeks for 96 weeks
description: Disease activity measured by the SLE Disease Activity Index
measure: Disease Activity
time frame: Measured every 12 weeks for 96 weeks
description: Disease activity measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index
measure: Patient reported outcomes
time frame: Measured every 12 weeks for 96 weeks
description: The PROMIS 29 Adult Profile
measure: Patient reported outcomes
time frame: Measured every 12 weeks for 96 weeks
description: Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items
measure: Patient reported outcomes
time frame: Measured every 12 weeks for 96 weeks
description: Patient Global Visual Analogue Scale
measure: Immunologic mediators
time frame: Measured every 12 weeks for 96 weeks
description: Serum levels of autoantibodies,cytokines and chemokines will be measured.
measure: Ophthalmologic toxicity
time frame: Measured after screening and prior to baseline and within 4 weeks after study completion
description: Dilated fundoscopic examination
measure: Ophthalmologic toxicity
time frame: Measured after screening and prior to baseline and within 4 weeks after study completion
description: Spectral domain ocular coherence tomography
measure: Ophthalmologic toxicity
time frame: Measured after screening and prior to baseline and within 4 weeks after study completion
description: Humphrey visual field testing
arm group label: Hydroxychloroquine
arm group type: Active Comparator
description: Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.
arm group label: Placebo oral capsule
arm group type: Placebo Comparator
description: Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.
intervention type: Drug
intervention name: Hydroxychloroquine
description: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
arm group label: Hydroxychloroquine
other name: Plaquenil
intervention type: Drug
intervention name: Placebo Oral Capsule
description: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
arm group label: Placebo oral capsule
other name: Placebo
criteria: 
gender: All
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: No
last name: Nancy J Olsen, MD
role: Principal Investigator
affiliation: Penn State MS Hershey Medical Center
last name: David R Karp, MD PhD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ, Liao D, Olsen NJ. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1425-1429. doi: 10.1002/acr.23802.
PMID: 30369087
citation: Olsen NJ, James JA, Arriens C, Ishimori ML, Wallace DJ, Kamen DL, Chong BF, Liao D, Chinchilli VM, Karp DR. Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial. Trials. 2018 Dec 20;19(1):694. doi: 10.1186/s13063-018-3076-7.
PMID: 30572906
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Nancy Olsen
investigator title: Professor of Medicine
mesh term: Lupus Erythematosus, Systemic
mesh term: Hydroxychloroquine