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Trial Outcomes & Findings for Tofacitinib for Inflammatory Eye Disease (NCT NCT03580343)

NCT ID: NCT03580343

Last Updated: 2021-02-01

Results Overview

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

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

180 days

Results posted on

2021-02-01

Participant Flow

Active uveitis despite at least 10mg prednisone for 2 weeks.

Participant milestones

Participant milestones
Measure
Tofacitinib Treatment
tofacitinib: tofacitinib extended release, 11mg, daily, oral
Overall Study
STARTED
5
Overall Study
COMPLETED
4
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tofacitinib
n=5 Participants
single arm- tofacitinib 11mg daily
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age, Continuous
58.8 years
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Tofacitinib Treatment
n=5 Participants
tofacitinib: tofacitinib extended release, 11mg, daily, oral
Treatment Failure (Composite Outcome)
0 Participants

Adverse Events

Tofacitinib Treatment

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tofacitinib Treatment
n=5 participants at risk
tofacitinib: tofacitinib extended release, 11mg, daily, oral
Skin and subcutaneous tissue disorders
cutaneous melanoma
20.0%
1/5 • Number of events 1 • 18 months
Skin and subcutaneous tissue disorders
squamous cell carcinoma
20.0%
1/5 • Number of events 1 • 18 months

Other adverse events

Adverse event data not reported

Additional Information

Lynn Hassman, Assistant Professor and Study PI

Washington University in St. Louis

Phone: 3142730341

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60