Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who participated and completed the core CAIN457A2206 study up to and including the end of the study (EoS) Visit, i.e. Visit 16 (Week 24), were allowed to enter the extension study upon signing informed consent.
Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or a later visit could enter the extension study within three weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they met the criteria below. Patients who did not enter the extension study within 3 weeks of completing the study discontinuation visit of the core study, were to have an additional baseline visit (Visit 17) and required to meet the criteria below:
The number of tender joints was the same or more than the core study baseline; or,
The number of swollen joints was the same or more than the core study baseline; or,
There was no improvement compared with the core study baseline in at least three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, Health Assessment Questionnaire and CRP
You may not be if
Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2206 study.
Patients who discontinued from the core CAIN457A2206 study before Visit 14 (Week 16), and patients who completed the core study or discontinued the core study more than 2 weeks before the baseline visit.
Pregnant or lactating women
Presence of active infection
Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile
Clareo Health | Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
