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NCT02535689 · ClinicalTrials.gov registry record · Phase 1
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus
A Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02535689 is a Phase 1 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 34 participants.
The verdict
NCT02535689, a Phase 1 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
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....
Interventions
- DRUG Placebo
- DRUG Tofacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-08-28 |
| Est. Completion | 2018-04-26 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02535689
The ClinicalTrials.gov registry entry for NCT02535689 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02535689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02535689 about?
NCT02535689 is a clinical study titled "Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus". 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 ...
What is the current status of trial NCT02535689?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2015-08-28. Estimated completion is 2018-04-26.
What interventions are being tested in trial NCT02535689?
The interventions under investigation include: Placebo (DRUG), Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT02535689?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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