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Janus kinase (JAK) inhibitor

Tofacitinib for Lupus

Phase 1 & 2
Waitlist Available
Led By Hermine Brunner, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8 and 24 compared to baseline.
Awards & highlights

Study Summary

This trial will study the effects of a new drug, TOFA, on young adults with lupus. The aim is to see if it is safe and effective. The trial will be conducted at two medical centers in Ohio.

Eligible Conditions
  • Lupus
  • Cutaneous Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8 and 24 compared to baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8 and 24 compared to baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oral Clearance (CL/F) (Cohort 1 only)
Secondary outcome measures
AUCt (Cohort 1 only)
Cmax (Cohort 1 only)
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score
+4 more
Other outcome measures
Change in British Isles Lupus Activity Group (BILAG) score
Change in SKINDEX score
Change in SLE Disease Activity Index (SLEDAI) score
+2 more

Side effects data

From 2017 Phase 3 trial • 209 Patients • NCT02281552
12%
Nasopharyngitis
1%
Interstitial lung disease
1%
Anaemia
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib Immediate Release (IR)
Tofacitinib Modified Release (MR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tofacitinib ArmExperimental Treatment1 Intervention
open-label study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 3
~39970

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,583 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,861 Total Patients Enrolled
Hermine Brunner, MDPrincipal InvestigatorCincinnati Childrens Hospital Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I sign up for this opportunity to participate in this research?

"This dermatology study is currently enrolling 20 patients who have cutaneous lupus and are aged between 18-45."

Answered by AI

What are Tofacitinib's most popular indications?

"Tofacitinib is an effective medication for treating juvenile arthritis, even in patients who are unable to take methotrexate."

Answered by AI

How many individuals are partaking in this experiment?

"The clinical trial is definitely recruiting patients if the information on clinicaltrials.gov is anything to go off of. The last update was on 7/15/2022 and 20 patients are needed between 2 sites."

Answered by AI

Can you share any other studies that have been done using Tofacitinib?

"Tofacitinib is being trialled in 34 active clinical studies, 7 of which are Phase 3 trials. Most of the Tofacitinib research is based in Shanghai, but there are a total of 662 medical facilities running these tests across the world."

Answered by AI

Are investigators still looking for test subjects?

"Yes, this page on clinicaltrials.gov shows that the trial is looking for participants. The listing was put up on 8/23/2017 and last updated on 7/15/2022."

Answered by AI

Does this study have an age limit? If so, what is it?

"This particular trial is seeking out 18-45 year old patients. There are a total of 22 trials involving minors and 139 for senior citizens."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus
2017. "Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03288324.
~2 spots leftby Apr 2025
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