Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Completed · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

Background: Systemic lupus erythematosus (lupus) is an autoimmune disease that often involves many systems and organs of the body. Symptoms can include fever, joint pains, and rashes. Serious lupus can also damage organs like the kidneys, lungs, or brain. Drugs used for lupus can have serious side effects. Also, the drugs don t help some people. Researchers want to find new, more effective and safe treatments. Objective: To evaluate the safety and tolerability of the drug tofacitinib (study drug) in people with lupus. Eligibility: People ages 18 and older who have mild to moderate lupus and are not currently or haven t recently had certain lupus treatments. Design: Participants will be screened in another protocol. Participants will have 7 five-hour visits over about 3 months. They will fill out multiple questionnaires. They will have tests, including: * Physical exam * Blood and urine tests * ECG/EKG: Soft electrodes are stuck to the skin to monitor the heart. * Optional SphygmoCor: Cuffs are attached to the arm and thigh to measure blood pressure and flow speed. * Optional Endopat: A thimble-shaped cup is placed on the finger to measure blood flow. A cuff is put on the arm to measure blood pressure and flow. * Optional CAVI: ECG electrodes are placed on both wrists, a microphone placed on the chest, and a blood pressure cuff placed on each arm and leg to measure blood pressure and velocity. Participants will receive either the study drug or a placebo. They will take this twice a day by mouth for 56 days. Participants will be contacted by phone 4 times....

Key facts

Study ID

NCT02535689

Run by

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

People needed

34

Starts

2015-08-28

Expected to finish

2018-04-26

Last updated by the study team

2018-08-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.
• Current or prior treatment with rituximab, belimumab or any other biologic agent in the 6 months prior to screening.
• Current treatment with immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus). Glucocorticoids are allowed as per the inclusion criteria. At the investigator s discretion, glucocorticoids may be tapered during the study.
• Patients previously on methotrexate, mycophenolate mofetil, cyclosporine or tacrolimus should have stopped it for at least 8 weeks at the time of screening.
• Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within the 6 months prior to screening.
• Increase in glucocorticoid dose within 4 weeks of screening.
• A history of drug or alcohol abuse within the 6 months prior to screening.
• History of chronic liver disease or elevated LFTs:
• ALT or AST greater than or equal to 2x upper limit of normal at screening
• serum unconjugated bilirubin > 2mg/dL at screening
• Dialysis or serum creatinine >1.5mg/dL.
• Protein to creatinine ratio of more than 1 mg/mg or 24 hours urine protein of more than 1000 mg.
• Active urinary sediment (WBC, RBC or mixed cellular casts 1+ or more /hpf).
• Hypercholesterolemia: Values after an 8-12 hour fasting blood specimen: total cholesterol >250 mg/dL or LDL >180 mg/dl or hypertriglyceridemia (triglyceride >300 mg/dL) within plus or minus 45 days of screening visit.
• Active infection that requires the use of oral or intravenous antibiotics and has not resolved at least 2 weeks prior to the administration of the first dose of study medication.
• Active chronic infections including but not limited to HIV, Hepatitis B, Hepatitis C, and BK viremia at screening visit.
• History of cancer.
• Known active tuberculosis or untreated latent tuberculosis.
• History of opportunistic infections.
• Subjects with active renal or central nervous system disease or a BILAG A in any organ system.
• WBC <2500/Microlitre or ANC <1,000/Microlitre, Hgb <9.0 g/dL or platelets <70,000/Microlitre or absolute lymphocyte count < 500/Microlitre.
• Current treatment with potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) that would increase serum availability of tofacitinib. Past treatment with the above mentioned agent is allowed if it was more than a week prior to the administration of the first dose of study medication.
• Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the Investigator, would jeopardize the subject s safety following exposure to the study drug.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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