Secukinumab Open Label Roll-over Extension Protocol
- Conditions
- Health Condition 1: M148- Arthropathies in other specified diseases classified elsewhere
- Registration Number
- CTRI/2021/12/038694
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Signed informed consent must be obtained before any assessment is performed.
2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
3. Participant has completed the parent study until end of the follow-up period (unless otherwise specified in the parent protocol).
4. Participant is deriving benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement.
5. Participant is unable to obtain the marketed secukinumab formulation due to unavailable local registration or reimbursement.
1. Participant has discontinued study treatment in the parent protocol for any reason.
2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ong term safety as assessed by occurrence of AEs/SAEsTimepoint: Long term safety as assessed by occurrence of AEs/SAEs (Time frame- Up to 2 years)
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable