Secukinumab Open Label Roll-over Extension Protocol

Phase 4

Recruiting

• Conditions: Arthropathies in other specified diseases classified elsewhere,

• Registration Number: CTRI/2021/12/038694
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-30
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 646

Inclusion Criteria

• 1.Signed informed consent must be obtained before any assessment is performed.
• Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
• Participant has completed the parent study until end of the follow-up period (unless otherwise specified in the parent protocol).
• Participant is deriving benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement.
• Participant is unable to obtain the marketed secukinumab formulation due to unavailable local registration or reimbursement.

Exclusion Criteria

• Participant has discontinued study treatment in the parent protocol for any reason.
• 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
Long term safety as assessed by occurrence of AEs/SAEs	Long term safety as assessed by occurrence of AEs/SAEs (Time frame- Up to 2 years)

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (6)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Assured Care Plus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

ChanRe Rheumatology & Immunology Center & Research; 🇮🇳 Bangalore, KARNATAKA, India

Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute; 🇮🇳 Mumbai, MAHARASHTRA, India

Nizams Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

Shalby Hospital; 🇮🇳 Surat, GUJARAT, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Uma Kumar

Principal investigator

9868397253

umaakumar@yahoo.co.in