Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet… (NCT05105347) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis
130 participantsStarted 2021-11-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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