Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis

This study is currently recruiting participants.

Verified by Novartis, August 2009

First Received: February 21, 2007 Last Updated: August 11, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00438360

Purpose

The study will evaluate the efficacy of cyclosporine when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.

Condition	Intervention	Phase
Chronic Plaque Psoriasis	Drug: Cyclosporine A microemulsion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-week, Double-blind, Randomized, Placebo-controlled, Multicenter Study, to Evaluate the Effectiveness of Cyclosporine 2,5 mg/kg/Day Bid Twice a Week on Reducing Relapse Rate, in Maintenance Patients With Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Relapse rate, as assessed by PASI (Psoriasis Area and Severity Index )score

Secondary Outcome Measures:

Time to relapse
Change from baseline in PASI score at every visit and on relapse
Change from baseline in BSA (Body Surface Area) score at every visit and on relapse
Change from baseline in VAS (Visual Analogue Scale) for Patient Self assessment of pruritus at every visit and on relapse
Safety / Tolerability assessed by adverse events

Estimated Enrollment:	264
Study Start Date:	May 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438360

Contacts

Contact: novartis

41613241111

Locations

Italy
Novartis Investigative Site	Recruiting
Bari, Italy
Contact: novartis 41613241111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	COLO400CIT04
Study First Received:	February 21, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00438360 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Novartis:

Cyclosporine, chronic plaque psoriasis, intermittent therapy

Study placed in the following topic categories:

Anti-Infective Agents
Cyclosporine
Immunologic Factors
Skin Diseases
Psoriasis

Antifungal Agents
Antirheumatic Agents
Immunosuppressive Agents
Cyclosporins
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Psoriasis
Therapeutic Uses
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 10, 2009