Adults 18 to 45 Years Old who have Skin Lesions Associated with Lupus Needed for a Tofacitinib Investigational Drug Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to evaluate the safety, tolerability and effectiveness of the investigational drug tofacitinib (TOFA) to see if it helps young adults who have skin lesions associated with lupus, or systemic lupus erythematosus-cutaneous lesions (SLE-CL).

TOFA is considered investigational for this research study because it has been tested in adults with rheumatoid arthritis but has not been tested in young adults with lupus.

Who can participate?

Adults 18 to 45 years old who have skin lupus, or SLE-CL, may be eligible for participation.

Conditions

  • Lupus
  • Rheumatology

What will happen in the study?

If you qualify for this research study and you decide to participate, you will have about 21 visits to Cincinnati Children’s over the course of 76 weeks (a year and a half).

These are the tests and procedures that will happen to you during 1 or more study visits:

  • Physical exam: weight, height, blood pressure, pulse rate, and temperature
  • Skin exam: the study doctor will evaluate if you have a disease flare at every visit and may stop your participation in the study at any time if you have one
  • Blood samples: to make sure your body is working okay, to check for certain diseases, and to learn more about TOFA
  • Urine samples: to make sure your body is working okay and to check for certain diseases
  • Pregnancy test: either a urine or blood test to confirm you are not pregnant (if you are a female who is able to get pregnant)
  • Questionnaires: you and your parents will be asked to complete questionnaires about your lupus

This research study will be divided into 3 parts, A, B and C.

During Part A, which lasts up to 8 weeks, you will begin to take TOFA by mouth, in pill form, 2 times a day, in the morning and evening (about 12 hours apart). Throughout Part A, your study doctor will check your disease status and then let you know if you can continue to Part B of the study.

You will continue to take TOFA during Part B of this study, which will last for another 16 weeks.

If after Part A and B (24 weeks), your study doctor determines that you cannot participate any further, he/she will explain other possible treatments to you outside this study.

During Part C, if you continue to do well, your lupus medicines other than TOFA can be reduced until the study ends at 76 weeks.

You might be asked to participate in a sub study where your skin lesions will be photographed 2 times during the study and you will have a skin biopsy done at that time.

Interested participants will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered.

What are the good things that can happen from this research?

Being in this study may or may not help you right now; however, the possible benefits associated with participation may help other children with lupus in the future.

What are the bad things that can happen from this research?

The study medicine might have some side effects. A detailed list of possible side effects will be provided to those participants interested in knowing more about this study. The study doctor or someone on the study team will discuss these with you.

Will you/your child be paid to be in this research study?

Participants will not receive compensation for their time, effort and travel for this study.

Contact

Contact Us.Angela Merritt
513-803-2118
angela.merritt@cchmc.org
Cincinnati Children’s Hospital Medical Center
Division of Rheumatology
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Hermine Bruner, MD, MSc
Cincinnati Children’s Hospital Medical Center
Director, Division of Rheumatology