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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Nov 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a combination treatment for people with Behçet's disease who are experiencing a type of eye inflammation called uveitis. Specifically, the trial will compare two treatment approaches: one using adalimumab along with a medium dose of oral glucocorticosteroids (like prednisone) and another using adalimumab with a higher dose of glucocorticosteroids. The goal is to see if the lower dose is just as good as the higher dose in managing symptoms over a short period of three months.

To participate in this trial, individuals must have a confirmed diagnosis of Behçet's disease and be currently taking at least 10 mg of prednisone or its equivalent. However, there are some important exclusions—such as those who have received certain treatments recently, pregnant or breastfeeding women, individuals with specific health issues like heart failure or severe kidney problems, and others with serious infections or mental health conditions. Participants in the trial will be monitored closely, and their progress will be evaluated to ensure their safety and the effectiveness of the treatments being studied.

Gender

ALL

Eligibility 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