Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis
1 other identifier
interventional
130
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2021
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 3, 2021
October 1, 2021
5.1 years
October 19, 2021
November 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Uveitis control
Inflammation control according to SUN criteria (two steps decrease of anterior chamber cell or vitreous haze or decreased to zero) or active retinal lesion recession with vitreous haze less than 0.5 grade
3 months
Secondary Outcomes (4)
Best corrected visual acuity (BCVA)
3 months
Extent of vascular leakage
3 months
BOS 24 score
3 months
Uveitis deterioration
3 months
Study Arms (2)
Medium dose group (Adalimumab plus medium dose oral glucocorticosteroid)
EXPERIMENTALPatients will be given adalimumab with 30mg daily prednisone or equivalent with a fixed slow tapering plan.
High dose group (Adalimumab plus high dose oral glucocorticosteroid)
ACTIVE COMPARATORPatients will be given adalimumab with 60mg daily prednisone or equivalent with a fixed slow tapering plan.
Interventions
A loading dose of 80mg adalimumab will be given subcutaneously and then change to 40mg adalimumab every two weeks. Medium dose oral glucocorticosteroid (30mg/d prednisone or equivalent) will be given to the experimental dose group and high dose oral glucocorticosteroid (60mg/d prednisone or equivalent) will be given to the high dose group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Jaffe GJ, Dick AD, Brezin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852.
PMID: 27602665BACKGROUNDLevy-Clarke G, Jabs DA, Read RW, Rosenbaum JT, Vitale A, Van Gelder RN. Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders. Ophthalmology. 2014 Mar;121(3):785-96.e3. doi: 10.1016/j.ophtha.2013.09.048. Epub 2013 Dec 17.
PMID: 24359625BACKGROUNDVallet H, Riviere S, Sanna A, Deroux A, Moulis G, Addimanda O, Salvarani C, Lambert M, Bielefeld P, Seve P, Sibilia J, Pasquali J, Fraison J, Marie I, Perard L, Bouillet L, Cohen F, Sene D, Schoindre Y, Lidove O, Le Hoang P, Hachulla E, Fain O, Mariette X, Papo T, Wechsler B, Bodaghi B, Rigon MR, Cacoub P, Saadoun D; French Behcet Network. Efficacy of anti-TNF alpha in severe and/or refractory Behcet's disease: Multicenter study of 124 patients. J Autoimmun. 2015 Aug;62:67-74. doi: 10.1016/j.jaut.2015.06.005. Epub 2015 Jul 8.
PMID: 26162757BACKGROUNDKaburaki T, Namba K, Sonoda KH, Kezuka T, Keino H, Fukuhara T, Kamoi K, Nakai K, Mizuki N, Ohguro N; Ocular Behcet Disease Research Group of Japan. Behcet's disease ocular attack score 24: evaluation of ocular disease activity before and after initiation of infliximab. Jpn J Ophthalmol. 2014 Mar;58(2):120-30. doi: 10.1007/s10384-013-0294-0. Epub 2014 Jan 31.
PMID: 24482146BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2021
First Posted
November 3, 2021
Study Start
November 10, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 3, 2021
Record last verified: 2021-10