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

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Adalimumab; Prednisone

Criteria

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