Status:
COMPLETED
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01169844
Start Date
June 1 2010
End Date
November 1 2012
Last Update
June 10 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Hamburg, Germany, 22415
2
Novartis Investigative Site
Amsterdam, DE, Netherlands, 1100
3
Novartis Investigative Site
Meerssen, KR, Netherlands, 6231
4
Novartis Investigative Site
Glasgow, United Kingdom, G12 8TA