Secukinumab Open Label Roll-over Extension Protocol
- Conditions
- Autoimmunity, Inflammation
- Interventions
- Registration Number
- NCT04638647
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 715
- Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
- Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
- Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons).
- Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.
- Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.
- Participant has prematurely discontinued study treatment in the parent protocol.
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Secukinumab s.c. Secukinumab s.c. injection Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.
- Primary Outcome Measures
Name Time Method To evaluate long term safety as assessed by occurrence of AEs/SAEs up to 2 years Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Austin Regional Clinic Rheumatology
🇺🇸Austin, Texas, United States
Providence Medical Foundation
🇺🇸Fullerton, California, United States
Purushotham Akther and Roshan Kotha MD Inc
🇺🇸La Mesa, California, United States
Precn Comprehensive Clnl Rsch Solns
🇺🇸San Leandro, California, United States
Orrin Troum MD and Medical Associates
🇺🇸Santa Monica, California, United States
Inland Rheumatology Clinical Trials INC
🇺🇸Upland, California, United States
Medvin Clinical Research
🇺🇸Van Nuys, California, United States
Center for Rheumatology Research
🇺🇸West Hills, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Rheumatology Associates of South Florida
🇺🇸Boca Raton, Florida, United States
Homestead Assoc In Research Inc
🇺🇸Homestead, Florida, United States
Integral Rheumatology and Immunology Specialists IRIS
🇺🇸Plantation, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
FL Medical Clinic Orlando Health
🇺🇸Zephyrhills, Florida, United States
Illinois Bone And Joint Institute
🇺🇸Hinsdale, Illinois, United States
Dawes Fretzin Clinical Rea Group
🇺🇸Indianapolis, Indiana, United States
Klein and Associates
🇺🇸Hagerstown, Maryland, United States
Ahmed Arif Medical Research Center
🇺🇸Grand Blanc, Michigan, United States
Physician Research Collaboration
🇺🇸Lincoln, Nebraska, United States
Athritis Rheumatology and Back Disease Associates PA
🇺🇸Voorhees, New Jersey, United States
St Lawrence Health System
🇺🇸Potsdam, New York, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Altoona Center for Clin Res
🇺🇸Duncansville, Pennsylvania, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Southwest Rheum Rsrch LLC
🇺🇸Mesquite, Texas, United States
Accurate Clinical Research Inc
🇺🇸San Antonio, Texas, United States
Rheumatology Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
Novartis Investigative Site
🇨ðŸ‡St Gallen, Switzerland