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Tofacitinib for Diaphragm Injury

Phase 2

Recruiting

Led By Joseph Shrager, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing esophagectomy

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-6 years

Awards & highlights

Study Summary

This trial intends to show that a drug which has been shown to prevent VIDD in animals will also work in humans. If successful, this could lead to large clinical trials of the drug.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Tofacitinib may cause side effects like increased risk of infections due to its immune system suppression effect, potential liver enzyme elevations indicating liver injury, and possibly other common drug-related adverse events such as headaches or digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for or have had an esophagectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevention of ventilator-induced diaphragm dysfunction by JAK inhibition

Secondary outcome measures

Increase in muscle strength due to JAK inhibition

Other outcome measures

Exploratory: Determine mechanisms of changes in muscle strength and ventilator-induced diaphragm dysfunction by JAK inhibition.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TofacitinibExperimental Treatment1 Intervention

Patient will receive two days treatment with tofacitinib prior to the surgery.

Group II: PlaceboPlacebo Group1 Intervention

Patient will receive two days treatment with placebo prior to the surgery.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,820 Total Patients Enrolled

1 Trials studying Diaphragm Injury

58 Patients Enrolled for Diaphragm Injury

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,299 Total Patients Enrolled

Joseph Shrager, MDPrincipal InvestigatorStanford University

Media Library

Placebo to match Tofacitinib Clinical Trial Eligibility Overview. Trial Name: NCT03681275 — Phase 2

Diaphragm Injury Research Study Groups: Placebo, Tofacitinib

Diaphragm Injury Clinical Trial 2023: Placebo to match Tofacitinib Highlights & Side Effects. Trial Name: NCT03681275 — Phase 2

Placebo to match Tofacitinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03681275 — Phase 2

Frequently Asked Questions

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

Is there evidence to suggest that Tofacitinib 5 mg is a safe therapeutic resource?

"Considering the Phase 2 trial data, our team at Power has assigned Tofacitinib 5 mg a safety score of 2. There is evidence supporting its security, but none pointing to its efficacy yet."

Answered by AI

Are there any extant experiments involving Tofacitinib 5 mg?

"At present, 34 clinical trials for Tofacitinib 5 mg are in progress. Of these initiatives, 7 have reached Phase 3 development. The majority of the studies primarily take place in Shanghai; however, 662 medical centres across multiple locations offer this medication as part of a trial."

Answered by AI

Are currently enrolling participants to this research project?

"This clinical trial is seeking participants, as indicated by the information present on the clinicaltrials.gov website. The initial posting was made on September 3rd of 2019 and it saw its last update on October 24th of 2022."

Answered by AI

What medical conditions has Tofacitinib 5 mg been found to ameliorate?

"Tofacitinib 5 mg is typically prescribed for juvenile arthritis and can be a viable option for those with methotrexate intolerance, lack of efficacy to conventional therapy or inadequate response."

Answered by AI

How many participants is this medical trial projected to include?

"Affirmative. Clinicaltrials.gov has data that confirms this medical experiment is actively enrolling participants. This trial, which was initially posted on September 3rd 2019, needs 56 patients recruited from a single site for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction

Joseph B. Shrager, MD 2019. "Janus Kinase Inhibition to Prevent Ventilator-induced Diaphragm Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03681275.

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