Select Page

Systemic Lupus Erythematosus

Lupus is a serious disease but, in most cases, it can be controlled with medication. However, there are no cures and many patients must live a life of accommodation. And, the medications which are available all have side effects, some of which are quite troublesome. Because of this we are searching for newer and better treatments. Lupus has not received the attention it deserves from those who develop new medications because lupus is not a common disease and it is very difficult to measure as it can be very different from individual to individuals and from one day to the next. Because of this there has been only one new medication approved for SLE in the last 50 years and that medication is for milder forms of lupus.

To learn more about lupus, you may want to contact the Lupus Foundation of America, the Arthritis Foundation, or the American College of Rheumatology.

Better Treatments for Lupus Needed

Newer and better treatments are needed.  The only way to develop new treatments for SLE it to test them in patients with a variety of types of lupus.  The more patients who participate in this research, the more quickly we will know if a particular treatment is effective and for which types of lupus. And, the more quickly we know, the sooner an effective new treatment will be available. 

Several potential treatments for SLE are now being tested. One involves the medication baricitinib (Olumiant) which was recently approved by the FDA for the treatment of rheumatoid arthritis. The CRDSG is currently studying baricitinib which it believes has considerable potential. To learn more about this experimental treatment for lupus, continue to read about SLE BRAVE Study.

SLE-BRAVE Trial on ClinicalTrials.gov*

ClinicalTrials.gov is a US Government website listing all clinical research studies being performed in the United States (and elsewhere), especially those that involve experimental treatments that may be submitted for approval to the FDA. It is an official listing with accurate, verifiable information maintained by the National Library of Medicine. It describes each study in detail and provides information for both prospective study participants, researchers, and others. The information is complete, accurate, and up to date. 

It is recommended that potential participants read the entire listing | Read This

However, it may not be easily understood. In order to make it more accessible, we have provided a summary below…

BRAVE II Study Summary (from Clinical Trials.gov)*

* Source: U.S. National Library of Medicine

The SLE-Brave Study is a research study which compares an experimental medication called baricitinib at 2 different doses to placebo in patients with systemic lupus.

What is the purpose of study?

The purpose of the study is to determine if baricitinib is effective and safe in treating lupus.

What are the different treatments being studied?

Study participants will be assigned to one of two doses of baricitinib, 2 mg or 4 mg per day , and will  compared to participants assigned to placebo (an inert or inactive substance, sometimes referred to as a “sugar pill.”). 

A participant or study subject will receive only one of these treatments. Exactly which experimental treatment will be given is determined by a random process similar to tossing a coin or throwing a die (dice).

All of the experimental treatments are in pill form and the pills will appear identical so that neither the subject nor the physician knows which treatment the subject is receiving. In that way, expectations or the desire to improve won’t influence the assessments of the true effectiveness of the study medicine.

What about my current treatment for SLE?

During the study, participants will remain on most of their previous medications which may include prednisone, Plaquenil (hydroxychloroquine), anti-inflammatory medications (ibuprofen, naproxen, Celebrex, etc.), methotrexate, azathioprine (Imuran), and mycophenolate (Cellcept), etc. Biologic treaments (Benlysta, Rituxan, Enbrel, etc.) would, however, have to be discontinued for safety reasons.

Study treatments will continue for 1 year. After 1 year, those who wish may continue in the study and are guaranteed to receive the baricitinib for 2-3 years.

Who is eligible to participate?

In order to qualify for the study, a potential participant must…

  1. have systemic lupus for at least 3 months
  2. be over 18 years of age
  3. continue to have the lupus antibodies in their blood
  4. have ongoing lupus issues but not of the severe or life threatening kind
  5. not have active kidney disease or ongoing brain problems due to lupus
  6. be on some lupus treatment but not currently taking cyclophosphamide(Cytoxan), rituximab (Rituxan), or belimumab (Benlysta), or any other experimental treatments for lupus 

Study Visits—what is involved?

In general, study visits occur on a monthly basis. At the first visit and most of the subsequent visits, you will be asked to complete questionnaires about your lupus, be examined by a rheumatologist, and have blood and urine specimens obtained.

Scheduling of appointments will be at your convenience so as not to be disruptive to you work or home life.

About Us

Cincinnati Rheumatic Disease Study Group
10495 Montgomery Road, Suite 26
Cincinnati, OH 45242
(513) 559-2130

Connect With Us

1000 Patients Helped by 18 Rheumatologists Since 1991!

Copyright ©2019 - Cincinnati Rheumatic Disease Study Group. All rights reserved. Internet Presence by Main Street Marketing

About Us

Cincinnati Rheumatic Disease Study Group
10495 Montgomery Road, Suite 26
Cincinnati, OH 45242
(513) 559-2130

Connect With Us

1000 Patients Helped by 18 Rheumatologists Since 1991!

 

Copyright ©2019 - Cincinnati Rheumatic Disease Study Group. All rights reserved.
Internet Presence by Main Street Marketing