Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

Part of paid clinical trials in Avondale, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06331312
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Polymyalgia Rheumatica

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — BIOLOGICAL
    2 x 150mg/1mL PFS secukinumab

Study Details

The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

Key Dates

Start date
Jun 28, 2024
Status verified
Jun 2026
Primary completion
May 8, 2028
Completion
May 8, 2028

Study Design

Enrollment
161 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab 300mg
    All eligible participants will receive secukinumab 300 mg s.c. (2 x 150mg/1mL PFS secukinumab) from baseline and every 4 weeks up to 2 years. The study medication may be modified/adjusted after the initial doses of 300mg s.c. (decreased to 150mg s.c. q4w or increased again from 150mg s.c. q4w to 300mg s.c. q4w) if deemed appropriate by the investigator. Dose modification/adjustment may only occur from Week 24 visit onwards. The modification/adjustment of the study medication will be determined at a site visit.

Primary Outcome Measure

Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: After the first dose of study treatment and within 84 days after the last dose ]

Locations (13)

FacilityCityStateZIPSite coordinators
Arizona Arthritis and Rheumatology Associates PLLCAvondaleArizona85392-
Sun Valley Arthritis Center LtdPeoriaArizona85381-
Center for Rheumatology ResearchWest HillsCalifornia91307-
Millennium Clinical TrialsWestlake VillageCalifornia91361-
Rheumatology Associates of South FloridaBoca RatonFlorida33486-
West Broward Rheumatology Associates IncTamaracFlorida33321-
Klein and AssociatesHagerstownMaryland21740-
Clinical Research Inst of MISaint Clair ShoresMichigan48081-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Paramount Med Rsrch and Consult LLCMiddleburg HeightsOhio44130-
Accurate Clinical Research IncHoustonTexas77089-
Prolato Clinical Research CenterHoustonTexas77054-
Advanced Rheumatology of HoustonSpringTexas77382-

Find similar trials in Avondale, AZ

By research site
Arizona Arthritis and Rheumatology Associates PLLC· Avondale, AZSun Valley Arthritis Center Ltd· Peoria, AZCenter for Rheumatology Research· West Hills, CAMillennium Clinical Trials· Westlake Village, CARheumatology Associates of South Florida· Boca Raton, FLWest Broward Rheumatology Associates Inc· Tamarac, FL

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