← Back to Search

Anti-malarial

Hydroxychloroquine for Lupus (SMILE Trial)

Phase 2

Waitlist Available

Led By Nancy J Olsen, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 15 and 49 years of age, inclusive, at Visit 1

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured after screening and prior to baseline and within 4 weeks after study completion

Awards & highlights

SMILE Trial Summary

This trial is testing whether the drug hydroxychloroquine can prevent lupus in people at risk for the disease. Effects on the disease, patient symptoms, and changes in the immune system will be measured.

Who is the study for?

This trial is for individuals aged 15-49 with a risk of developing lupus, evidenced by certain immune system markers. They must have some but not all symptoms of lupus and cannot have been treated with immunosuppressants or antimalarials before. People with other autoimmune diseases (except thyroid conditions), significant eye disease, liver problems, psoriasis, porphyria, infections like HIV or hepatitis B/C, cancer (with exceptions), or those pregnant/breastfeeding are excluded.Check my eligibility

What is being tested?

The study tests if Hydroxychloroquine can prevent the progression of lupus in at-risk patients compared to a placebo. It's randomized and double-blind meaning neither participants nor researchers know who gets the real medicine versus the placebo. The trial will measure symptom progression, patient-reported outcomes and changes in immune response markers.See study design

What are the potential side effects?

Potential side effects include vision problems due to eye toxicity, digestive issues such as stomach pain or nausea, skin reactions like rashes, headaches and dizziness. Rarely it may cause mood changes or muscle weakness.

SMILE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 15 and 49 years old.

SMILE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured after screening and prior to baseline and within 4 weeks after study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured after screening and prior to baseline and within 4 weeks after study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured after screening and prior to baseline and within 4 weeks after study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SLICC Score

Secondary outcome measures

Disease Activity

Disease Progression

Immunologic mediators

+2 more

SMILE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HydroxychloroquineActive Control1 Intervention

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.

Group II: Placebo oral capsulePlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,687 Total Patients Enrolled

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

485 Previous Clinical Trials

1,086,712 Total Patients Enrolled

2 Trials studying Lupus

270 Patients Enrolled for Lupus

Nancy J Olsen, MDPrincipal InvestigatorPenn State MS Hershey Medical Center

Media Library

Hydroxychloroquine (Anti-malarial) Clinical Trial Eligibility Overview. Trial Name: NCT03030118 — Phase 2

Lupus Research Study Groups: Hydroxychloroquine, Placebo oral capsule

Lupus Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT03030118 — Phase 2

Hydroxychloroquine (Anti-malarial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03030118 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what conditions is Hydroxychloroquine typically prescribed?

"Hydroxychloroquine can be employed for the management of malaria, q fever, and rheumatoid arthritis."

Answered by AI

Could you please elucidate the other investigations that have included Hydroxychloroquine?

"Presently, 64 Hydroxychloroquine clinical trials are operating with 7 of them in their final stage. While the majority of these investigations take place in Hangzhou, Zhejiang, a global total of 786 medical facilities are researching this drug."

Answered by AI

Do I meet the criteria to partake in this experiment?

"This medical trial is accepting 187 participants aged between 15 and 49 who suffer from lupus erythematosus, systemic. To be considered for enrolment, patients must meet these criteria."

Answered by AI

Does this experimental research include individuals aged 35 and older?

"This experiment only has room for participants between the ages of 15 and 49, whereas there are 29 trials available to those younger than 18 years old and 158 studies open to individuals over 65."

Answered by AI

How many people are currently participating in this research experiment?

"This trial is not currently enrolling new participants. It was originally posted on December 28th 2017, and the last update happened on November 2nd 2022. If you are seeking alternative studies, 124 trials for systemic lupus erythematosus and 64 clinical studies involving Hydroxychloroquine are presently recruiting patients."

Answered by AI

Are there still openings available for participation in this clinical investigation?

"Unfortunately, the clinical trial mentioned is currently not recruiting new participants. It was initially made available on December 28th 2017 and last edited November 2nd 2022. However, there are 124 trials involving lupus erythematosus systemic in need of candidates as well as 64 studies looking for volunteers to take hydroxychloroquine."

Answered by AI

What safety protocols have been established for utilizing Hydroxychloroquine?

"There is pre-existing evidence backing Hydroxychloroquine's safety, so it was assigned a rating of 2. However, there have not been any studies demonstrating its efficacy yet."

Answered by AI

How many locations are participating in this experimental trial?

"This clinical trial is taking place in Aurora, Oklahoma City and Charleston as well as 7 other cities. Specifically, the University of Colorado Anschutz Medical Campus, Oklahoma Medical Research Foundation and the Medical University of South carolina are involved."

Answered by AI