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

Conditions: Rheumatoid arthritis
MedDRA version: 14.1Level: 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-HU

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients who completed the phase III study CAIN457F2309;Secondary Objective: 1) To evaluate the long-term efficacy of secukinumab with respect to changes in HAQ-DI relative to baseline over time up to Month 60<br><br>2) To evaluate the long-term efficacy of secukinumab with respect to the proportion of subjects achieving major clinical response (continuous six-month period of ACR70 response) over time up to Month 60 <br><br>3) To evaluate the long-term efficacy of secukinumab with respect to the changes in DAS28 relative to baseline over time up to Month 60;Primary end point(s): ACR 20, 50 and 70;Timepoint(s) of evaluation of this end point: Over the entire duration of the study up to Month 60

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Questionnaire Disability Index (HAQ-DI)<br>2) Major clinical response <br>3) DAS28<br>;Timepoint(s) of evaluation of this end point: Over the entire duration of the study up to Month 60