Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03344640
Phase
PHASE2
Status
Completed

Conditions

  • Tendinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • secukinumab — DRUG
    AIN457 300 mg subcutaneously for 12 weeks
  • Placebo — OTHER
    Placebo to match AIN457 subcutaneously for 12 weeks

Study Details

This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.

Key Dates

Start date
Dec 15, 2017
Status verified
Oct 2021
Primary completion
Aug 2, 2019
Completion
Oct 17, 2019

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: secukinumab
    AIN457 300 mg subcutaneously (s.c.) for 12 weeks
  • Placebo Comparator: Placebo
    Placebo subcutaneously for 12 weeks

Primary Outcome Measure

The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score at Week 14 in All Patients - Statistical Analysis Results of Total WORC Scores at Week 14 [ Time Frame: Week 14 (Day 99) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85053-
Novartis Investigative SiteLa MesaCalifornia91942-
Novartis Investigative SiteClearwaterFlorida33765-
Novartis Investigative SiteMiami LakesFlorida33014-
Novartis Investigative SiteTampaFlorida33603-

Find similar trials in Phoenix, AZ

By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· La Mesa, CANovartis Investigative Site· Clearwater, FLNovartis Investigative Site· Miami Lakes, FLNovartis Investigative Site· Tampa, FL

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