70 Participants Needed

Tofacitinib for Diaphragm Injury

CA
Overseen ByCheyenne A Clinical Research Coordinator, B.S, M.S
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

We intend, with this study, to prove that blocking the molecular mechanisms whose blockade prevents VIDD in animals, will indeed prevent the development of VIDD in humans as well. We believe that this evidence will serve as the required basis for proceeding with large, ICU-based clinical trial(s) of a drug to prevent VIDD.

Will I have to stop taking my current medications?

If you are taking any immunosuppressant or antifungal medications, you will need to stop taking them to participate in this trial.

How is the drug tofacitinib unique for treating diaphragm injury?

Tofacitinib is unique because it is an oral drug that selectively inhibits Janus kinases, which are involved in immune and inflammatory processes. This mechanism of action is different from other treatments that may not target these specific pathways, and its oral administration offers a convenient alternative to injectable therapies.12345

What data supports the effectiveness of the drug tofacitinib for diaphragm injury?

Tofacitinib is known to be effective for treating rheumatoid arthritis, as it is an oral drug that inhibits Janus kinases, which are involved in inflammation. While there is no direct evidence for diaphragm injury, its effectiveness in reducing inflammation in other conditions suggests potential benefits.16789

Who Is on the Research Team?

JS

Joseph Shrager, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for patients who are undergoing esophagectomy surgery and do not have neuromuscular diseases, liver or kidney issues, or severe lung problems. They shouldn't be on immunosuppressants or antifungal meds, haven't lost more than 5% of their weight recently, aren't pregnant, and don't have a history of tuberculosis.

Inclusion Criteria

I am scheduled for or have had an esophagectomy.

Exclusion Criteria

I am currently taking immunosuppressant or antifungal medications.
I have a condition that could affect my diaphragm's ability to work.
My liver or kidney function is not normal.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two days of treatment with either placebo or tofacitinib prior to surgery

2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

5-6 years

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo to match Tofacitinib
  • Tofacitinib
Trial Overview The study tests if Tofacitinib (Xeljanz) can prevent diaphragm muscle weakness caused by mechanical ventilation during surgery compared to a placebo. It's based on previous animal studies showing that blocking certain molecular pathways can prevent this condition.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TofacitinibExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

A study involving 52 healthy Chinese subjects demonstrated that a generic immediate-release tofacitinib tablet is bioequivalent to the brand-name version, showing no significant differences in key pharmacokinetic measures like maximum plasma concentration and area under the curve.
The study found that food intake did not significantly affect the drug's absorption or elimination, indicating that tofacitinib can be taken with or without food without impacting its efficacy or safety.
Pharmacokinetics and Bioequivalence of 2 Immediate-Release Tofacitinib Tablet Formulations in Chinese Healthy Volunteers Under Fasting and Fed Conditions.Li, X., Liu, L., Deng, Y., et al.[2022]
Tofacitinib at doses of 3 mg or higher taken twice daily showed significant efficacy in treating active rheumatoid arthritis, with ACR20 response rates reaching up to 71.9% by week 12, compared to 22.0% for placebo.
The treatment was generally well-tolerated, with manageable side effects, the most common being urinary tract infections and diarrhea, indicating a favorable safety profile for patients.
Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs.Fleischmann, R., Cutolo, M., Genovese, MC., et al.[2022]
Tofacitinib aspartate (7.13 mg) demonstrated bioequivalence to the reference formulation tofacitinib citrate (8.08 mg) in a study involving 41 healthy volunteers, indicating similar pharmacokinetic profiles for both formulations.
The study found that both formulations were well-tolerated, with no significant differences in maximum concentration (Cmax) and area under the concentration-time curve (AUClast), suggesting that tofacitinib aspartate can be a viable alternative to the existing formulation.
Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects.Shin, W., Yang, AY., Yun, H., et al.[2022]

Citations

Pharmacokinetics and Bioequivalence of 2 Immediate-Release Tofacitinib Tablet Formulations in Chinese Healthy Volunteers Under Fasting and Fed Conditions. [2022]
Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. [2022]
Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects. [2022]
Development and evaluation of tofacitinib transdermal system for the treatment of rheumatoid arthritis in rats. [2022]
Model-Informed Development and Registration of a Once-Daily Regimen of Extended-Release Tofacitinib. [2018]
Tofacitinib: a review of its use in adult patients with rheumatoid arthritis. [2022]
Safety, tolerability, and pharmacokinetics of single oral doses of tofacitinib, a Janus kinase inhibitor, in healthy volunteers. [2022]
A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects. [2022]
European perspective on the management of rheumatoid arthritis: clinical utility of tofacitinib. [2020]
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