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Hydroxychloroquine for Lupus (SMILE Trial)
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.
SMILE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSMILE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SMILE Trial Design
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Who is running the clinical trial?
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- I have taken or am taking antimalarial drugs like hydroxychloroquine.I take more than 10 mg of prednisone daily or changed my dose in the last 3 months.I cannot take hydroxychloroquine due to an existing eye condition, liver issues, psoriasis, porphyria, or an allergy.I have no cancer history except for certain skin cancers or treated cervical cancer.I do not have any ongoing serious infections.My eye doctor says it's not safe for me to use hydroxychloroquine due to my eye condition.I haven't changed my NSAID medication in the last 3 months.I have been diagnosed with fibromyalgia by a doctor.I have an autoimmune disorder that is not related to the thyroid.I am currently taking or have taken drugs that affect my immune system.I am between 15 and 49 years old.
- Group 1: Hydroxychloroquine
- Group 2: Placebo oral capsule
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what conditions is Hydroxychloroquine typically prescribed?
"Hydroxychloroquine can be employed for the management of malaria, q fever, and rheumatoid arthritis."
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."
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."
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."
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."
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."
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."
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."
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What portion of applicants met pre-screening criteria?
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