Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

• Conditions: Rheumatoid arthritis; MedDRA version: 15.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-002760-27-SK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-11
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 345

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 69

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 exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified