NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221181

Registered date:05/08/2010

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedpsoriasis
Date of first enrollment05/08/2010
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : AIN457 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subcutaneously Administered

Outcome(s)

Primary OutcomeSafety and tolerability as measured by Adverse Events and clinically significant changes in vital signs and clinical laboratory variables.
Secondary OutcomeLong-term efficacy as assessed by PASI 50, PASI 75 and PASI 90 achievement and an improvement of the IGA during the trial.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria- Patients who completed the core study ( A Multicenter Trial of Subcutaneously Administered AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis)
Exclude criteria-Patients who experience a second consecutive full relapse at visit 13 of the core study ( A Multicenter Trial of Subcutaneously Administered AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis) Other protocol-defined inclusion/exclusion criteria may apply

Related Information

Contact

Public contact
Name
Address 0120-003-293
Telephone
E-mail
Affiliation Novartis Pharma K.K.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation