JRCT ID: jRCT2080221181
Registered date:05/08/2010
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | psoriasis |
Date of first enrollment | 05/08/2010 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Safety and tolerability as measured by Adverse Events and clinically significant changes in vital signs and clinical laboratory variables. |
---|---|
Secondary Outcome | Long-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 maximum | Not applicable |
Gender | Both |
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
Primary Sponsor | Novartis Pharma K.K. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101218 |
Contact
Public contact | |
Name | |
Address | 0120-003-293 |
Telephone | |
Affiliation | Novartis Pharma K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |