Uveitis Clinical Trial
Official title:
Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
Verified date | February 2021 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral glucocorticosteroid in patients with refractory Behçet's uveitis (BDU). Half of the participants will receive IFNα2a while the other half will receive CsA.
Status | Completed |
Enrollment | 28 |
Est. completion date | January 31, 2021 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Refractory BDU 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 with at least one of the following IMT agents: cyclophosphamide=50mg/d, CsA=100mg/d, azathioprine=50mg/d, methotrexate=15mg/w, mycophenolate=1000mg/d, tacrolimus=2mg/d. Exclusion Criteria: - Previous treatment with interferon-a; - Pregnancy, breast feeding women; - Malignancy; - Renal impairment (creatinine > 1.5 mg/dl); - Uncontrolled hypertension or diabetes; - 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 large dose corticosteroids; - Previous intolerance to CsA; - 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Percentage of participants who achieve complete remission or partial remission | Within the 12-month follow-up period | |
Primary | Complete remission rate | Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis | Within the 12-month follow-up period | |
Primary | Tolerance rate | Percentage of participants who adhere to the treatment without severe side effects | Within the 12-month follow-up period | |
Secondary | Time to reach complete remission | The time from the therapy initiation to a complete absence of ocular inflammation for complete responders | Within the 12-month follow-up period | |
Secondary | Duration of relapse-free | The duration between the therapy initiation to the relapse for partial responders and nonresponders | within the 12-month follow-up period | |
Secondary | BCVA | Changes of best-corrected visual acuity | Within the 12-month follow-up period | |
Secondary | BOS24 score | Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24) | Within the 12-month follow-up period | |
Secondary | Glucocorticoid-sparing effect | Changes of corticosteroid dosage | Within the 12-month follow-up period | |
Secondary | Incidence of adverse effects | Incidence of adverse effects | Within the 12-month follow-up period | |
Secondary | Incidence of significant abnormal changes in vital signs or laboratory test results | Incidence of significant abnormal changes in vital signs or laboratory test results | Within the 12-month follow-up period | |
Secondary | Adverse effects profile | Types of drug adverse effects | Within the 12-month follow-up period |
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