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

NCT02535689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-08-09

No results posted yet for this study

Summary

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....

Conditions

Interventions

DRUG

Tofacitinib

Oral administration of tofacitinib, 5 mg

DRUG

Placebo

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Sarfaraz A Hasni, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-28
Primary Completion
2018-04-26
Completion
2018-04-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535689 on ClinicalTrials.gov