Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

NCT ID: NCT06310837

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2026-05-01

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.

Detailed Description

The study will be followed up in the screening-baseline period and at 4,8,12,18,24,36, and 48 weeks after the start of the study drug. The ETDRS letter number change of the best corrected visual acuity ( BCVA ) at 24 weeks compared with the baseline was used as the main indicator. The last follow-up was performed at 48 weeks.

Conditions

Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ADA+MMF group

Adalimumab biosimilars with immunosuppressants therapy

Group Type: EXPERIMENTAL

Adalimumab Biosimilars Injection

Intervention Type: 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.

Immunosuppressive Agents

Intervention Type: DRUG

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

Corticosteroids+MMF group

Corticosteroids with immunosuppressive therapy；

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

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

Immunosuppressive Agents

Intervention Type: DRUG

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

Interventions

Adalimumab Biosimilars Injection

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.

Intervention Type: DRUG

Corticosteroid

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

Intervention Type: DRUG

Immunosuppressive Agents

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

Intervention Type: DRUG

Other Intervention Names

Subcutaneous injection of adalimumab biosimilars; Oral corticosteroids; Immunosuppressant

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 70 years old ( including boundary value ), male or female.

2. At least one eye is diagnosed as noninfectious intermediate uveitis, posterior uveitis or panuveitis.

3. 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.

4. At least one eye is diagnosed as active uveitis at baseline；

5. Subject is voluntary to participate in the study and sign the informed consent form.

Exclusion Criteria

1. Subject with isolated anterior uveitis.

2. 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).

3. Subject is suspected or diagnosed as infectious uveitis.

4. 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.

5. Subject with best corrected visual acuity (BCVA) worse than 20/400 (ETDRS logMAR > 1.34 or <20 letters) in the better eye.

6. Subject with other fundus diseases.

7. Subject with demyelinating diseases.

8. Subject has a contraindication to pupil dilation with mydriatic eyedrops.

9. Subject with corneal or lens opacity that precludes visualization of the anterior segment and fundus.

10. 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.

11. 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.

12. 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.

13. 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.

14. Prior biologic and immunosuppressant therapy other than corticosteroids at any time.

15. Subject with a systemic inflammatory disease that requires continued therapy with oral corticosteroids or a prohibited immunosuppressive agent at Screening or Baseline visits.

16. Fertile woman who has a positive serum pregnancy test at the screening visit or plans for pregnancy and sperm donation during the trial and within 6 months after the end of the study.

17. Other subjects who are considered by the investigator to be inappropriated for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Eye Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Shandong Eye Hospital

OTHER

Sponsor Role: collaborator

Shenzhen Eye Hospital

OTHER

Sponsor Role: collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Chi

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Eye Hospital

Locations

Shenzhen Eye Hospital

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

2023KYPJ300

Identifier Type: -

Identifier Source: org_study_id