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

NCT05414201 | Completed Phase 4

• 1 other identifier: M20-387
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Non-infectious Intermediate Posterior- or Pan-uveitis

Keywords

Humira; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Percentage of participants that achieve quiescence in both eyes

  Quiescence is defined as no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤ 0.5+

  Week 30

Secondary Outcomes (6)

• Percentage of participants that achieve no active lesions in both eyes

  Week 30

• Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes

  Week 30

• Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes

  Week 30

• Percentage of participants that achieve no worsening of Best Corrected Visual Acuity (BCVA) by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes

  Week 30

• Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load

  Week 30

Study Arms (1)

Adalimumab

EXPERIMENTAL

Participants will receive a loading dose of Adalimumab 80mg SC at Baseline followed a week later by a dose of Adalimumab 40mg SC every other week.

Drug: Adalimumab

Interventions

Adalimumab DRUG

Subcutaneous Injection

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of Chinese descent, with full Chinese parentage.
• Diagnosed with active non-infectious intermediate uveitis, posterior uveitis, or panuveitis defined by the presence of at least 1 of the following in at least one eye:
• Active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesion
• ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature \[SUN\] criteria); or
• ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/SUN criteria).
• Receiving oral prednisone from ≥ 10mg/day to ≤ 60mg/day (or oral corticosteroids equivalent) for at least two weeks before Screening and remaining on the same dose from Screening to Baseline.

You may not qualify if:

• Participants with the following ocular events:
• Isolated anterior uveitis;
• Confirmed or suspected infectious uveitis;
• Ocular masquerade syndromes, such as ocular lymphoma;
• Presumed ocular histoplasmosis syndrome;
• Serpiginous choroidopathy;
• Scleritis;
• Corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial;
• Macular edema as the only sign of uveitis;
• Severe VH that precludes visualization of the fundus at the baseline visit;
• Intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury;
• Best Corrected Visual Acuity less than 20 letters Early Treatment Diabetic Retinopathy Study (ETDRS) in either eye at the Baseline visit;
• Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy;
• Neovascular/wet age-related macular degeneration;
• Abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

Peking University First Hospital /ID# 243055

Beijing, Beijing Municipality, 100034, China

Location

Shanghai General hospital /ID# 247252

Shanghai, Shanghai Municipality, 200080, China

Location

The second affiliated hospital of Zhejiang University school of medicine /ID# 247251

Hangzhou, Zhejiang, 310009, China

Location

Eye hospital,WMU Zhejiang Eye Hospital /ID# 247253

Wenzhou, Zhejiang, 325612, China

Location

Beijing Tongren Hospital, CMU /ID# 243054

Beijing, 100730, China

Location

Tianjin Medical University Eye Hospital /ID# 243056

Tianjin, 300384, China

Location

Xi'an people's hospital/Xi'an fourth hospital /ID# 243371

Xi'an, 710000, China

Location

Related Links

• clinical study report synopsis

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: July 7, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (7)