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

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AIN457A
Other
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic arthritis, IgG1K monoclonal antibody, Interleukin -17A neutralizing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457/AIN457 3 mg/kg.

Placebo/AIN457 3 mg/kg.

Arm Description

Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.

Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total IL-17 Concentration in Blood at Steady-state
Total IL-17 concentration was not reported due to assay limitations.
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.

Full Information

First Posted
July 14, 2010
Last Updated
May 26, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01169844
Brief Title
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic arthritis, IgG1K monoclonal antibody, Interleukin -17A neutralizing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457/AIN457 3 mg/kg.
Arm Type
Experimental
Arm Description
Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Arm Title
Placebo/AIN457 3 mg/kg.
Arm Type
Placebo Comparator
Arm Description
Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks.
Intervention Type
Biological
Intervention Name(s)
AIN457A
Intervention Type
Other
Intervention Name(s)
Other
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events and Serious Adverse Events
Description
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.
Time Frame
Up to 64 weeks (End of the Study Treatment)
Secondary Outcome Measure Information:
Title
Total IL-17 Concentration in Blood at Steady-state
Description
Total IL-17 concentration was not reported due to assay limitations.
Time Frame
Up to 64 weeks
Title
Mean Serum Concentration Measured at Steady State
Description
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.
Time Frame
Weeks 0, 8, 16, 20, 24, 28, 32, 36, 40 and at 4 and 12 weeks after the last administration at Week 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Novartis Investigative Site
City
Amsterdam
State/Province
DE
ZIP/Postal Code
1100
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Meerssen
State/Province
KR
ZIP/Postal Code
6231
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE2 4HH
Country
United Kingdom

12. IPD Sharing Statement

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

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