A prospective multicenter comparative clinical trial between corticosteroid pulse therapy vs. combination therapy of oral corticosteroid and cyclosporine on Vogt-Koyanagi-Harada disease

UMIN ID: UMIN000014387

Registered date:27/06/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Vogt-Koyanagi- Harada disease
• Date of first enrollment: 2014/07/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1.Steroid monotherapy group methyl predonisolone (mPSL) 1000mg per day, intravenous infusion for 3 days The oral PSL (either a daily dose of 1mg/kg or 60mg for 2 weeks PSL will be tapered with decreasing dosage 10mg every 1weeks until 40mg PSL will be tapered with decreasing dosage 5mg every 2weeks until 20mg PSL will be tapered with decreasing dosage 2.5mg every 2weeks until PSL 5mg PSL 3mg/day for 2 weeks, and therapy is terminated
2.Oral prednisolone and cyclosporine combination therapy group Oral predonisolone (1mg/Kg or 60mg per day) for 2 weeks PSL will be tapered with decreasing dosage 10mg every 1weeks until 40mg At the time when the dose of prednisolone decreases to 35 mg / day, start the combined use of cyclosporine 3 mg / kg. Oral predonisolone is decreased and terminated as the same manner of storoid monotherapy group, but cyclosporine is maintained 3-2mg/Kg per day until the PSL is terminated.

Outcome(s)

• Primary Outcome: The efficacy to prevent recurrances of uveitis and systemic inflammation of VKH disease, safety at one year after the initiation of therapies

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Systemic steroids within 90 days 2. Abnormal values of complete blood counts 3. Abnormal liver enzymes and renal function 4. Infectious diseases(ex.tuberculosis, hepatitis B, hepatitis C, syphilis etc.) 5. Those who have diseases in which corticosteroids and cyclosporine are contraindication. 6. Those who are being treated with immune suppression agents other than prednisolone 7. Investigators declare a subject ineligible for any sound reasons

Related Information

• Primary Sponsor: Miyata Eye Hospital
• Source(s) of Monetary Support: none