non-infectious intermediate and posterior uveitis, and pan-uveitis
Conditions
Interventions
None listed
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria 1.Aged =>15 years and =<75 years as of the date of treatment given for the target relapse 2.Patients with a diagnosis of non-infectious intermediate and posterior uveitis, and pan-uveitis accompanying VKH disease or sarcoidosis 3.Patients with a target relapse meeting the criteria specified for this study 4.Patients whose medical record at the study sites during a 6-month period before and 12-month period after the start date of treatment of target relapse is available for the investigation. 5.Patients in whom systemic corticosteroid therapy is resumed or the dose of ongoing systemic corticosteroids is increased on the day on which treatment of target relapse starts
Exclusion criteria
Exclusion criteria: Patients who meet either of the following criteria 1.Patients undergoing an ophthalmic operation during the 12-month assessment period from the day on which treatment of target relapse starts. 2.Patients in whom dose reduction or discontinuation of systemic corticosteroids cannot be allowed due to the underlying disease (e.g., treatment of pulmonary lesion associated with sarcoidosis), an immunologic disease, interstitial pneumonia, or other relevant condition during the 12-month assessment period from the day on which treatment of target relapse starts. 3.Patients who received the study drug during the 12-month assessment period from the day on which treatment of target relapse starts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total dose of systemic corticosteroids in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis during 12 months after the target relapse. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the total days of systemic corticosteroid treatment during 12 months in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis. 2) To assess the total dose of systemic corticosteroids per month at 1, 3, 6, 9 and 12-month in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis. 3) To evaluate the relationship between the total dose of systemic corticosteroids and the rate of re-relapse during 12 months after the target relapse by calculating the coefficient estimate from logistic analysis. 4) To summarize concomitant medications used together with systemic corticosteroids in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis. 5) To calculate the rates and their 95% confidence intervals of steroid-free patients at 1, 3, 6, 9 and 12-month after the target relapse. 6) To assess the total days of high dose systemic corticosteroid treatment (10mg/day) during 12 months in the treatment of relapses of non-infectious, intermediate, posterior uveitis, or panuveitis associated with VKH disease or sarcoidosis. 7) To assess the total days of high dose systemic corticosteroid treatment at 1, 3, 6, 9 and 12-month after the target relapse. 8) To investigate the total dose of systemic corticosteroids by demographic factors (age, gender, comorbidities, systemic corticosteroid treatment history, primary disease). 9) To evaluate the change of each clinical evaluation item from the best point before the target relapse and to the best point after the target relapse. 10) To describe the number of times of another relapse after the target relapse. 11) To assess the rate of adverse drug reactions (ADRs) associated with systemic corticosteroids after the target relapse. | — |
Countries
Japan
Contacts
Public ContactAtsuo Otsuka
EP CRSU Co., Ltd. Clinical Study Division
Outcome results
None listed