RECRUITING

Secukinumab Open Label Roll-over Extension Protocol

Conditions

Autoimmunity, Inflammation Secukinumab, Post trial access

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-12-22

Study Completion:2028-02-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04638647

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.

Ages Eligible for Study:6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Providence Medical Foundation

Fullerton, California, 92835

United States

Purushotham Akther and Roshan Kotha MD Inc

La Mesa, California, 91942

United States

Precn Comprehensive Clnl Rsch Solns

San Leandro, California, 94578

United States

Orrin Troum MD and Medical Associates

Santa Monica, California, 90404

United States

Inland Rheumatology Clinical Trials INC

Upland, California, 91786

United States

Medvin Clinical Research

Van Nuys, California, 91405

United States

Center for Rheumatology Research

West Hills, California, 91307

United States

Denver Arthritis Clinic

Denver, Colorado, 80230

United States

Homestead Assoc In Research Inc

Homestead, Florida, 33033

United States

Integral Rheumatology and Immunology Specialists IRIS

Plantation, Florida, 33324

United States

Conquest Research

Winter Park, Florida, 32789

United States

FL Medical Clinic Orlando Health

Zephyrhills, Florida, 33542

United States

Illinois Bone And Joint Institute

Hinsdale, Illinois, 60521

United States

Dawes Fretzin Clinical Rea Group

Indianapolis, Indiana, 46256

United States

Klein and Associates

Hagerstown, Maryland, 21740

United States

Ahmed Arif Medical Research Center

Grand Blanc, Michigan, 48439

United States

Physician Research Collaboration

Lincoln, Nebraska, 68516

United States

Athritis Rheumatology and Back Disease Associates PA

Voorhees, New Jersey, 08043

United States

St Lawrence Health System

Potsdam, New York, 13676

United States

Oregon Health Sciences University

Portland, Oregon, 97239

United States

Altoona Center for Clin Res

Duncansville, Pennsylvania, 16635

United States

West Tennessee Research Institute

Jackson, Tennessee, 38305

United States

Austin Regional Clinic Rheumatology

Austin, Texas, 78731

United States

Southwest Rheum Rsrch LLC

Mesquite, Texas, 75150

United States

Accurate Clinical Research Inc

San Antonio, Texas, 78229

United States

Rheumatology Pulmonary Clinic

Beckley, West Virginia, 25801

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-22

Study Completion Date2028-02-29

Study Record Updates

Study Start Date2020-12-22

Study Completion Date2028-02-29

Terms related to this study

Keywords Provided by Researchers

Secukinumab, Post trial access

Additional Relevant MeSH Terms

Autoimmunity, Inflammation