Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

NCT06310837 | Active Not Recruiting

• 1 other identifier: 2023KYPJ300
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, prospective, randomized controlled non-inferior clinical study. A total of 120 subjects with non-infectious intermediate, posterior, or panuveitis were enrolled in Zhongshan Ophthalmic Center and three other centers. They were randomly assigned to the experimental group and the control group according to ( 1 : 1 ). We hypothesized that adalimumab biosimilars combined with immunosuppressive agents in the treatment of non-infectious uveitis is not inferior to glucocorticoids combined with immunosuppressive agents, and there are no additional adverse events and safety issues.

Conditions

Uveitis

Keywords

Uveitis; Corticosteroids; Adalimumab biosimilars

Outcome Measures

Primary Outcomes (1)

• Change of ETDRS letter count for BCVA at week 24 from baseline

  The best corrected visual acuity of the patient would be examined by the ETDRS visual acuity chart according to the visual acuity examination SOP. Change of ETDRS letter count for BCVA at week 24 from baseline were the main indicator, the outcome at other follow-up time points（Baseline, weeks 4, 8, 12, 18, 36, 48）would also be included in the outcome analysis.

  week 24

Secondary Outcomes (12)

• Proportion of patients with weight gain at week 24 from baseline

  week 24

• Time of treatment failures

  week 24

• Number of treatment failures

  week 24

• Change of Visual Functioning Questionnaire- 25 (VFQ-25) composite score from baseline

  week 24

• Change of anterior chamber inflammation at week 24 from baseline

  week 24

Study Arms (2)

ADA+MMF group

EXPERIMENTAL

Adalimumab biosimilars with immunosuppressants therapy

Drug: Adalimumab Biosimilars Injection; Drug: Immunosuppressive Agents

Corticosteroids+MMF group

ACTIVE COMPARATOR

Corticosteroids with immunosuppressive therapy；

Drug: Corticosteroid; Drug: Immunosuppressive Agents

Interventions

Adalimumab Biosimilars Injection DRUG

Adalimumab biosimilars: 80 mg was subcutaneously injected for the first time in the first week, and then 40 mg was subcutaneously injected every two weeks from the first week to the 48 th week.

Also known as: Subcutaneous injection of adalimumab biosimilars

ADA+MMF group

Corticosteroid DRUG

Patients received no less than 1 mg / kg.d glucocorticoid at week 0, then implemented according to the standard reduction scheme.

Also known as: Oral corticosteroids

Corticosteroids+MMF group

Immunosuppressive Agents DRUG

Mycophenolate mofetil 1g bid for more than 3 months, maintenance dose not less than 0.5g bid

Also known as: Immunosuppressant

ADA+MMF group; Corticosteroids+MMF group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years old ( including boundary value ), male or female.
• At least one eye is diagnosed as noninfectious intermediate uveitis, posterior uveitis or panuveitis.
• Subject is on prednisone ≥ 10 mg/day (or corticosteroid equivalent) for at least 2 weeks prior to Screening and remains on the same dose from screening to baseline visit.
• At least one eye is diagnosed as active uveitis at baseline；
• Subject is voluntary to participate in the study and sign the informed consent form.

You may not qualify if:

• Subject with isolated anterior uveitis.
• Subject with prior inadequate response to or intolerance to high-dose corticosteroids (equivalent of prednisone 1 mg/kg/day or 60 to 80 mg/day).
• Subject is suspected or diagnosed as infectious uveitis.
• Uncontrolled glaucoma or high intraocular pressure, defined as intraocular pressure\>25 mmHg after treatment with ≥ 2 anti-glaucoma drugs or evidence of glaucomatous optic nerve injury.
• Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR \> 1.34 or \<20 letters) in the better eye.
• Subject with other fundus diseases.
• Subject with demyelinating diseases.
• Subject has a contraindication to pupil dilation with mydriatic eyedrops.
• Subject with corneal or lens opacity that precludes visualization of the anterior segment and fundus.
• Topical corticosteroids and/or topical NSAID\>3 drops per day in the 14 days prior to baseline; Dexamethasone/betamethasone or equivalent subconjunctival steroid within 30 days prior to baseline; Parafbulbar, intravitreal (IVT), suprasoroidal, or periocular corticosteroid injections were administered within 60 days prior to baseline; Received IVT anti-VEGF therapies less than 60 days prior to baseline; Dexamethasone (Ozurdex) IVT implant within 6 months prior to baseline; Fluocinolone acetonide IVT implant within 3 years prior to baseline.
• Subject with history of prior intraocular surgery within 90 days prior to baseline or any planned (elective) eye surgery within the next 1 year from baseline.
• Subject is diagnosised or suspected tuberculosis, hepatitis B virus, hepatitis C virus, HIV, syphilis infection or with other uncontrolled active infections or other infections that would put the subject at uncontrolled risk.
• Subject with severe, progressive, or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebral diseases or with malignant tumors or with moderate to severe heart failure and subjects who are considered by the investigator to be at unacceptable risk by participating in the study.
• Prior biologic and immunosuppressant therapy other than corticosteroids at any time.
• Subject with a systemic inflammatory disease that requires continued therapy with oral corticosteroids or a prohibited immunosuppressive agent at Screening or Baseline visits.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• The Eye Hospital of Wenzhou Medical University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Shandong Eye Hospital: collaborator
• Shenzhen Eye Hospital: collaborator

Study Sites (1)

Shenzhen Eye Hospital

Shenzhen, Guangdong, 518040, China

Location

MeSH Terms

Conditions

Uveitis

Interventions

Adrenal Cortex Hormones; Immunosuppressive Agents

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Wei Chi

  Shenzhen Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 15, 2024
• Study Start: March 27, 2024
• Primary Completion: October 31, 2025
• Study Completion: May 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)