Tofacitinib for Inflammatory Eye Disease
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|ClinicalTrials.gov Identifier: NCT03580343|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2018
Results First Posted : February 1, 2021
Last Update Posted : February 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Uveitis Scleritis||Drug: tofacitinib||Phase 2|
This study is a prospective, single-site, open-label investigation of tofacitinib for refractory uveitis. The study will be for 24 weeks, with potential 1-year extension for treatment responders. The patients will self-administer the medication.
Eligible patients would be those patients with a diagnosis of uveitis who meet the following criteria:
- Disease sufficiently severe to require treatment with systemic corticosteroids, and
- Referred from Ophthalmology to Rheumatology or Uveitis specialist for a steroid-sparing agent
For patients naive to oral steroid-sparing therapy (e.g., methotrexate, azathioprine, or mycophenolate), tofacitinib will be initiated as monotherapy. For patients who have failed or had only a partial response to oral steroid-sparing therapy, tofacitinib will be initiated as an add-on therapy. For patients intolerant to a conventional agent, tofacitinib will be initiated as replacement monotherapy. For patients who have failed biologic therapy (e.g. adalimumab), biologic therapy will be discontinued and tofacitinib will be initiated as replacement therapy without change to concurrent conventional steroid-sparing agents. Study visits will occur at baseline/enrollment, and weeks 4, 8, 12, 16, & 24 (+/- 2 weeks). Clinic visits may occur more frequently as determined by the treating physician. Laboratory monitoring (Table 1) will be obtained according to standard of care for drug toxicity monitoring. Clinical responses will be evaluated at 24 weeks, with the primary outcome defined as treatment failure.
All patients will undergo a predetermined oral steroid taper starting at 60mg of prednisone (or equivalent) and tapering over 14 weeks (Table 2). All patients will undergo a predetermined topical steroid drop taper starting at their current dose (Table 3).
Patients will have an ophthalmological evaluation by their treating ophthalmologist at Washington University. Steroid sparing therapy will be managed by rheumatologists or uveitis specialists at Washington University. All patients will be evaluated for an associated systemic rheumatologic condition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tofacitinib for the Treatment of Inflammatory Eye Disease|
|Actual Study Start Date :||April 4, 2019|
|Actual Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||April 4, 2021|
Experimental: Tofacitinib Treatment
11mg extended-release tofacitinib, once daily, oral
tofacitinib extended release, 11mg, daily, oral
Other Name: TOFA
- Treatment Failure (Composite Outcome) [ Time Frame: 180 days ]new inflammatory lesions relative to baseline OR 2-step increase in anterior chamber cell or vitreous haze OR worsening of visual acuity by two or more rows on ETDRS chart
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
|United States, Missouri|
|Washington University in Saint Louis|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Lynn M Hassman, MD PhD||Washington University School of Medicine|