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Tofacitinib for Inflammatory Eye Disease

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ClinicalTrials.gov Identifier: NCT03580343
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
Non-infectious inflammatory eye disease, such as uveitis and scleritis, is a chronic, auto-immune process that leads to vision loss. While steroids are effective in the short term, the side-effect profile of chronic steroid use necessitates the identification of effective steroid-sparing therapies. Tofacitinib is a small molecule that inhibits the signaling pathways of multiple inflammatory cytokines. The investigators plan to evaluate whether tofacitinib may have efficacy for patients with uveitis and / or scleritis.

Condition or disease Intervention/treatment Phase
Uveitis Scleritis Drug: tofacitinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tofacitinib for the Treatment of Inflammatory Eye Disease
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tofacitinib Treatment Drug: tofacitinib
tofacitinib extended release, 11mg, daily, oral


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Failure (composite outcome) [ Time Frame: 180 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of uveitis
  • a clinical response to steroids
  • active disease requiring at least 10mg of prednisone daily (or steroid equivalent)

Exclusion Criteria:

  • suspected or confirmed ocular infection
  • chronic or recurring infections, such as HIV
  • renal insufficiency that would preclude safe administration of tofacitinib
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580343


Contacts
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Contact: Feigl 3147474179 laceyfeigl@wustl.edu

Locations
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United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
More Information
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03580343     History of Changes
Other Study ID Numbers: tofacitinib_eye_disease
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uveitis
Eye Diseases
Scleritis
Uveal Diseases
Scleral Diseases
 Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action