Secukinumab Open Label Roll-over Extension Protocol

Description

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.

Conditions

Autoimmunity, Inflammation

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Study Overview

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Study Details

Study overview

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.

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment

Secukinumab Open Label Roll-over Extension Protocol

Condition
Autoimmunity, Inflammation
Intervention / Treatment

-

Contacts and Locations

Fullerton

Providence Medical Foundation, Fullerton, California, United States, 92835

La Mesa

Purushotham Akther and Roshan Kotha MD Inc, La Mesa, California, United States, 91942

San Leandro

Precn Comprehensive Clnl Rsch Solns, San Leandro, California, United States, 94578

Santa Monica

Orrin Troum MD and Medical Associates, Santa Monica, California, United States, 90404

Upland

Inland Rheumatology Clinical Trials INC, Upland, California, United States, 91786

Van Nuys

Medvin Clinical Research, Van Nuys, California, United States, 91405

West Hills

Center for Rheumatology Research, West Hills, California, United States, 91307

Denver

Denver Arthritis Clinic, Denver, Colorado, United States, 80230

Homestead

Homestead Assoc In Research Inc, Homestead, Florida, United States, 33033

Plantation

Integral Rheumatology and Immunology Specialists IRIS, Plantation, Florida, United States, 33324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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).
  • 2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
  • 3. 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).
  • 4. 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.
  • 5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.
  • 1. Participant has prematurely discontinued study treatment in the parent protocol.
  • 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).

Ages Eligible for Study

6 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2028-02-29