Status:
COMPLETED
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque ps...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Outpatients 18 years of age and older (max 65 years)
- Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period
- Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for \>8 weeks and \<16 weeks
- PASI still \<75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission)
- Exclusion criteria:
- Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)
- Severe chronic degenerative diseases
- Severe uncontrolled hypertension
- Body weigh \>110 kg
- Abnormal liver function
- Hyperkalemia or hyperuricemia
- Clinically significant impairment of hematopoietic and cardiovascular function
- Concomitant therapy with nephrotoxic medications
- Patients with malignancy or a history of malignancy
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
- Clinically significant uncontrolled bacterial, viral or fungal infection
- Evidence of drug and/or alcohol abuse
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00438360
Start Date
May 1 2006
End Date
November 1 2007
Last Update
August 9 2011
Active Locations (1)
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1
Novartis Investigative Site
Bari, Italy