A Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Participants Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate, Posterior, or Pan-Uveitis

Study Identifier
M20-387
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Chinese (China)

Study Details

Medical Condition
  • Uveitis (UV)
  • Study Drug
  • Adalimumab
  • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU) are sight threatening diseases with a high patient burden and negative impact on quality of life. Corticosteroids remain the mainstay of first-line treatment for NIIPPU in China despite serious side effects associated with long-term and high-dose corticosteroid use. Adalimumab is used to treat NIIPPU in adults who have had inadequate response to corticosteroids, or who need corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. The purpose of this study is to assess adverse events and effectiveness of adalimumab in Chinese participants requiring high dose corticosteroids with NIIPPU.

    Adalimumab is a conditionally approved drug in China used to treat participants with NIIPPU. All participants will receive the same treatment. Approximately 87 adult participants will be enrolled at approximately 15 sites in China.

    Participants will receive one subcutaneous loading dose of adalimumab at baseline followed a week later by a lower dose of adalimumab every other week for up to 30 weeks.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Peking University First Hospital /ID# 243055
    Beijing, Beijing Municipality, China, 100034
    Status
    Not applicable
    Location
    Shanghai General hospital /ID# 247252
    Shanghai, Shanghai Municipality, China, 200080
    Status
    Not applicable
    Location
    The second affiliated hospital of Zhejiang University school of medicine /ID# 247251
    Hangzhou, Zhejiang, China, 310009
    Status
    Not applicable
    Location
    Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253
    Wenzhou, Zhejiang, China, 325612
    Status
    Not applicable
    Location
    Beijing Tongren Hospital, CMU /ID# 243054
    Beijing, China, 100730
    Status
    Not applicable
    Location
    Tianjin Medical University Eye Hospital /ID# 243056
    Tianjin, China, 300384
    Status
    Not applicable
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