Please note: This trial has finished recruiting and is not accepting new participants.
Research Center: Clinical Research of West Florida
Location: 605 N. Howard Ave.,Tampa, FL 33606 United States
Lead Researcher: Dr. Edgard Janer
IRB Committee: This study has been reviewed and approved by the Advarra Institutional Review Board

Background

According to the Centers for Disease Control and Prevention (CDC), systemic lupus erythematosus (SLE) is an autoimmune disease. SLE is the most common type of lupus wherein the immune system attacks the tissues causes widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Currently, there is no cure for lupus. However, some interventions can help manage symptoms.

This research seeks to investigate the effectiveness of the study medication (Cenerimod) in reducing the symptoms of lupus. Researchers also want to assess the impact of the investigational medication on the quality of life and fatigue among those with lupus.

Interested participants must be aged 18 to 75 years old who are diagnosed with systemic lupus erythematosus (SLE). Participants must be willing to comply with the necessary study requirements. 

Why Participate? 

• You may experience improvements and manage your symptoms.
• You will have eye and echo exams completed once a month at no cost.
• You will be compensated up to $1,050 for participating in this study.
• You may contribute valuable information that may benefit others with lupus in the future.
• You will be helping to advance medical research.

Your Rights

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
• Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

• Adults aged 18 to 75 years old who are diagnosed with systemic lupus erythematosus (SLE). The diagnosis must have been made at least 6 months ago.
• Able to attend 14 study visits at the research site for over approximately a year.
  • There is 1 visit about every 3-4 weeks. Each visit will take about 2.5 hours to complete. 
  • The visits at the end of the study are phone call follow-ups. 
  • The investigational medication is a small tablet that is to be taken once every day.

About The Research Centers:

Clinical Research of West Florida
Over the past 20 years, CRWF has reached over 10,000 patients and successfully conducted over 1,000 Phase I-IV research studies. The company’s model of a private research-only company has become wide-spread throughout America. CRWF’s founders are proud to be one of the first and one of the best in quality of performance and most importantly, in patient satisfaction.

Please note:

Due to the current situation with COVID-19 pandemic, the study team would like to point out the following:

• The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
• The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
• Hand sanitisers are available at the research site.
• The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19. 
• Any staff suspected to have COVID-19, or has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
• Interested participants will not be left waiting for a long period of time and will be quickly attended to. 
• Parking is available at the research site.
• The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. All travel expenses will be reimbursed.
• The research site/institution is taking all precautionary measures to ensure the safety of the study participants.