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Small Molecule
Tofacitinib for Inflammatory Eye Disease
Phase 2
Waitlist Available
Led By Lynn M Hassman, MD PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions
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.
Eligible Conditions
- Uveitis
- Episcleritis
- Scleritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment Failure (Composite Outcome)
Side effects data
From 2020 Phase 4 trial • 4372 Patients • NCT0209246722%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Osteoarthritis
6%
Influenza
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Femur fracture
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tofacitinib TreatmentExperimental Treatment1 Intervention
11mg extended-release tofacitinib, once daily, oral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
FDA approved
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,305 Total Patients Enrolled
1 Trials studying Uveitis
2 Patients Enrolled for Uveitis
Lynn M Hassman, MD PhDPrincipal InvestigatorWashington University School of Medicine