Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169844
• Other study ID #: CAIN457A2206E1
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• AIN457A

Other:
• Other

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Hamburg
Netherlands	Novartis Investigative Site	Amsterdam	DE
Netherlands	Novartis Investigative Site	Meerssen	KR
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events and Serious Adverse Events	Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.	Up to 64 weeks (End of the Study Treatment)
Secondary	Total IL-17 Concentration in Blood at Steady-state	Total IL-17 concentration was not reported due to assay limitations.	Up to 64 weeks
Secondary	Mean Serum Concentration Measured at Steady State	This outcome measure is assessing AIN457 Mean Serum Concentration Measured at Steady State. A competitive ELISA method was used for bioanalytical analyses and the anticipated LLOQ is 80 nanograms/mL serum.	Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52.