Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00438360
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00438360
Study Brief:
Protocol Section:
NCT00438360