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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 January 2025 |
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Main ID: |
NCT03030118 |
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Date of registration:
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15/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Anti-Malarials in Incomplete Lupus Erythematosus
SMILE |
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Scientific title:
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Study of Anti-Malarials in Incomplete Lupus Erythematosus |
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Date of first enrolment:
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December 28, 2017 |
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Target sample size:
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187 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03030118 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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David R Karp, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT Southwestern Medical Center |
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Name:
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Nancy J Olsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Penn State MS Hershey Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Between 15 and 49 years of age, inclusive, at Visit 1.
2. Anti-nuclear antibody (ANA) titer of 1:80, or greater, as determined by
immunofluorescence assay (IFA).
3. Participants must have at least one (but not three or more) additional clinical or
laboratory criterion from the 2012 Systemic Lupus International Collaborating
Clinics (SLICC) classification criteria.
4. Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative and ability for subject to comply with the
requirements of the study.
Exclusion Criteria:
1. The subject meets the 2012 SLICC classification criteria for SLE at Visit 1 (i.e.,
ANA plus 3 other criteria, or ANA plus biopsy-proven lupus nephritis).
2. The subject has been diagnosed with another autoimmune disorder, other than
autoimmune thyroid conditions.
3. The subject has fibromyalgia, based on clinical history and exam.
4. The subject has previously been or is currently being treated with oral antimalarial
agents including hydroxychloroquine, chloroquine, or quinacrine.
5. The subject is currently or has been treated with immunosuppressive, immune
modifying, or cytotoxic medications as listed in Section 7.2.
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 (HIV), 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. The subject has significant findings on ophthalmological examination that, in the
opinion of the examining Ophthalmologist, prevent safe use of hydroxychloroquine.
12. The subject has other contraindications to treatment with hydroxychloroquine
including pre-existing ocular disease, hepatic impairment, psoriasis, porphyria, or
allergy to the drug or class.
13. Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of
prednisone per day, or equivalent, or a change in corticosteroid dose within the 3
months prior to Visit 1.
14. Starting, stopping, or changing the dose of over the counter or prescription
non-steroidal anti-inflammatory drugs (NSAIDs) in the three months prior to Visit 1.
15. Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study.
16. 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.
17. Inability to comply with the study visit schedule and procedures.
Age minimum:
15 Years
Age maximum:
49 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Hydroxychloroquine
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Drug: Placebo Oral Capsule
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Primary Outcome(s)
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SLICC Score
[Time Frame: Measured every 12 weeks for 96 weeks.]
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Secondary Outcome(s)
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Immunologic mediators
[Time Frame: Measured every 12 weeks for 96 weeks]
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Ophthalmologic toxicity
[Time Frame: Measured after screening and prior to baseline and within 4 weeks after study completion]
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Patient reported outcomes
[Time Frame: Measured every 12 weeks for 96 weeks]
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Disease Activity
[Time Frame: Measured every 12 weeks for 96 weeks]
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Disease Progression
[Time Frame: Measured every 12 weeks for 96 weeks]
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Secondary ID(s)
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STUDY00003506
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U01AR071077
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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