An extension study to assess the long termefficacy, safety and tolerability of secukinumab in active rheumatoid arthritis Patients.
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2014/03/004506
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 18
> > Subjects must give a written informed consent before any assessment is performed.
> > Subjects must have completed the 104-week treatment period in the core study
> > Subjects who are deemed by the investigator to benefit from continued secukinumab therapy.
1. Use of other investigational drugs except for secukinumab during the core study.
2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
4.Any subject who is deemed not to be benefiting from the study drug based upon lack of
improvement or worsening of their symptoms.
5. Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab during the core study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method