Effect of Immunosuppressants With Adalimumab Biosimilars vs Corticosteroids on Noninfectious Uveitis

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Uveitis

Treatments: Drug: Corticosteroid; Drug: Adalimumab Biosimilars Injection; Drug: Immunosuppressive Agents

Study type: Interventional

Funder types: Other

Identifiers

NCT06310837

2023KYPJ300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

ADA+MMF group

Experimental group

Description:

Adalimumab biosimilars with immunosuppressants therapy

Treatment:

Drug: Immunosuppressive Agents

Drug: Adalimumab Biosimilars Injection

Corticosteroids+MMF group

Active Comparator group

Description:

Corticosteroids with immunosuppressive therapy；

Treatment:

Drug: Immunosuppressive Agents

Drug: Corticosteroid