Trials Sponsors Conditions Drugs Pricing

Conditions

Autoimmunity, Inflammation Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to severe Chronic Plaque Psoriasis, Juvenile idiopathic Arthritis

Keywords

Secukinumab, Post trial access

Outcome Measures

Primary Outcomes (1)

To evaluate long term safety as assessed by occurrence of AEs/SAEs
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
up to 2 years

Study Arms (1)

Secukinumab s.c.

EXPERIMENTAL

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.

Biological: Secukinumab s.c. injection

Interventions

Secukinumab s.c. injectionBiological

Secukinumab pre-filled syringes (PFS) for s.c. injection

Secukinumab s.c.

SECUKINUMABType not reported

SECUKINUMAB

Eligibility Criteria

Age6 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead
Novartis Pharma AG
Industrylead

Study Sites (171)

Providence Medical Foundation

Fullerton, California, 92835, United States

COMPLETED

Purushotham Akther and Roshan Kotha MD Inc

La Mesa, California, 91942, United States

COMPLETED

Precn Comprehensive Clnl Rsch Solns

San Leandro, California, 94578, United States

COMPLETED

Orrin Troum MD and Medical Associates

Santa Monica, California, 90404, United States

MeSH Terms

Conditions

Autoimmune DiseasesInflammation

Condition Hierarchy (Ancestors)

Immune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

December 22, 2020

Actual (reported)

Primary Completion

January 29, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Secukinumab Open Label Roll-over Extension Protocol

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Secukinumab s.c.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (171)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Secukinumab Open Label Roll-over Extension Protocol

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Secukinumab s.c.

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (171)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations