Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT01640938
• Date of registration: 12/07/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis
• Scientific title: A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis
• Date of first enrolment: September 2012
• Target sample size: 259
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01640938
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Germany, Hungary, Italy, Mexico, Romania, Russian Federation, Slovakia, Spain, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

1. Subjects who provide a written, signed and dated informed consent before any study
assessment is performed

2. Subjects must have participated in phase III study CAIN457F2309, must have completed
the entire treatment period and must have received secukinumab during phase III study
(either from start of phase III study or after re-assignment to one of the
secukinumab arms after week 16/24)

3. Subjects who are deemed by the investigator to benefit from continued secukinumab
therapy

Exclusion criteria:

1. Any subject taking other concomitant biologic immunomodulating agent(s) except
secukinumab

2. Any subject who is deemed not to be benefiting from the study drug based upon lack of
improvement or worsening of their symptoms

3. Any subject who continued to receive abatacept after week 16 during the phase III
study CAIN457F2309

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Secukinumab (AIN457)

Primary Outcome(s)

ACR 20, 50 and 70 [Time Frame: Over the entire duration of the study up to Month 60]

Secondary Outcome(s)

Change from baseline in individual ACR components [Time Frame: Over the entire duration of the study up to Month 60]

Immunogenicity (assessment of anti-secukinumab antibody development) [Time Frame: Weeks 104, 156, 208, 260, 268]

Subjects achieving DAS remission (DAS28 < 2.6) [Time Frame: Over the entire duration of the study up to Month 60]

Subjects achieving ACR/EULAR remission (defined as SDAI = 3.3) [Time Frame: Over the entire duration of the study up to Month 60]

Subjects achieving major clinical response (continuous six-month period of ACR70 response) [Time Frame: Over the entire duration of the study up to Month 60]

Safety and tolerability [Time Frame: Over the entire duration of the study]

Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Over the entire duration of the study up to Month 60]

Subjects achieving low disease activity (DAS28 = 3.2) and good/moderate EULAR response [Time Frame: Over the entire duration of the study up to Month 60]

Change from baseline in DAS28 [Time Frame: Over the entire duration of the study up to Month 60]

Quality of life assessment as measured by SF-36v2 [Time Frame: Weeks 104, 156, 208, 260]

Secondary ID(s)

2012-002760-27

CAIN457F2309E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors