Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 4

Conditions: Uveitis

Treatments: Drug: Adalimumab plus different doses of oral glucocorticosteroid

Study type: Interventional

Funder types: Other

Identifiers

NCT05105347

42-ZS-2925

Details and patient eligibility

About

This study is a multi-center randomized non-inferiority study that aims to observe the short-term (3 months) efficacy and safety of adalimumab plus medium-dose glucocorticosteroid (30mg/d prednisone or equivalent) with slow tapering for recurrent Behçet's uveitis (BU) attack compared with adalimumab plus high-dose glucocorticosteroid (60mg/d prednisone or equivalent) with slow tapering.

Full description

According to the most recent European League Against Rheumatism (EULAR) recommendation, patients presenting with an initial or recurrent episode of acute sight-threatening uveitis should be treated with high-dose glucocorticoids, infliximab or interferon-α. Adalimumab, another TNFα antagonist, is also considered as an alternative for infliximab and have proved its efficacy in several RCTs in the treatment of non-infectious intermediate, posterior and pan-uveitis. As higher dose glucocorticosteroid have greater side effects, this study aims to evaluate the non-inferior efficacy and safety of adalimumab plus medium-dose glucocorticosteroid compared with adalimumab plus high-dose glucocorticosteroid (and slow tapering) for recurrent posterior or pan-uveitis attack of Behcet's uveitis. Refractory BU is defined as relapse of posterior or panuveitis with at least 10mg daily prednisone (or equivalent). The acute attack will be controlled with adalimumab (80mg once, 40mg q2w thereafter) plus medium dose initial oral glucocorticosteroid (30mg daily prednisone or equivalent) in the "medium dose" group or plus high dose oral glucocorticosteroid (60mg daily prednisone or equivalent) in the "high dose" group with fixed tapering protocols. Patients will be followed up at 2w, 4w, 8w, and 12w after initiation of treatment. The primary endpoint is the inflammatory control rate. Secondary endpoints are BCVA, vascular leakage score on fundus fluorescein angiography (FFA), BOS 24 score and uveitis deterioration rate. The safety profiles of both groups will be also monitored.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Behçet's disease (BD) patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis
• The patient should be on ≥10mg/d oral prednisone or equivalent

Exclusion criteria

• Previous treatment with TNFα inhibitors within 3 months
• Pregnancy, breast feeding women
• Malignancy
• Heart failure
• Demyelinating diseases
• Renal impairment (creatinine > 1.5 mg/dl)
• Depression or other psychic disorders
• History of acute or chronic inflammatory joint or autoimmune disease
• Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement
• Organ or bone marrow transplant recipient, cardiac failure > NYHA III
• Acute liver disease with ALT or SGPT 2x above normal
• White blood cell count < 3500/mm^3
• Platelet count < 100000/mm^3
• Hgb < 8.5g/dl
• T-SPOT TB: ≥200 SFCs per 10^6 PBMC
• Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of intermediate dose corticosteroids
• Other severe ocular diseases or intraocular surgery within 3 months
• Media opacity precluding a clear view of the fundus
• Positive screen test for HBV, HCV, HIV infection or syphilis
• Body weight <45 kg
• Alcohol abuse or drug abuse
• Mental impairment
• Uncooperative attitude

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Medium dose group (Adalimumab plus medium dose oral glucocorticosteroid)

Experimental group

Description:

Patients will be given adalimumab with 30mg daily prednisone or equivalent with a fixed slow tapering plan.

Treatment:

Drug: Adalimumab plus different doses of oral glucocorticosteroid

High dose group (Adalimumab plus high dose oral glucocorticosteroid)

Active Comparator group

Description:

Patients will be given adalimumab with 60mg daily prednisone or equivalent with a fixed slow tapering plan.

Treatment:

Drug: Adalimumab plus different doses of oral glucocorticosteroid