Phase 4: testing Secukinumab s.c. injection for Autoimmunity, Inflammation
This study wants 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 registry: https://clinicaltrials.gov/study/NCT04638647 · Novartis Pharmaceuticals · enrollment listed as 1,000
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Secukinumab s.c. injection. The registry lists allocation as na. This study wants 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.
They plan to enroll about 1,000 people at 139 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
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
Interventions: Secukinumab s.c. injection
Primary outcome (registry wording): To evaluate long term safety as assessed by occurrence of AEs/SAEs
Who it is for (from inclusion criteria)
- Ages 6 Years to 100 Years
- 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
Who the registry excludes
- 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)
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
139 listed- Providence Medical Foundation — Fullerton, California (completed)
- Purushotham Akther and Roshan Kotha MD Inc — La Mesa, California (completed)
- Precn Comprehensive Clnl Rsch Solns — San Leandro, California (completed)
- Orrin Troum MD and Medical Associates — Santa Monica, California (completed)
- Inland Rheumatology Clinical Trials INC — Upland, California (completed)
- Medvin Clinical Research — Van Nuys, California (completed)
- Center for Rheumatology Research — Woodland Hills, California (completed)
- Denver Arthritis Clinic — Denver, Colorado (completed)
- Rheumatology Associates of South Florida — Boca Raton, Florida (recruiting)
- Homestead Assoc In Research Inc — Homestead, Florida (completed)
- IRIS Research and Development — Plantation, Florida (completed)
- Conquest Research — Winter Park, Florida (completed)
+ 111 sites outside the US on the same record
FAQ about this NCT record
Is NCT04638647 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04638647?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04638647?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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