A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

Part of paid clinical trials in Santa Monica, California.

Sponsor
Amgen
Study ID
NCT03783026
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Tablets for oral administration

Study Details

This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.

Key Dates

First listed
Dec 20, 2018
Start date
Feb 6, 2019
Status verified
Feb 2025
Primary completion
Oct 26, 2021
Completion
May 11, 2022

Study Design

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

Arms

  • Experimental: Apremilast
    Participants will receive apremilast 30 mg twice a day for 48 weeks.

Primary Outcome Measure

Change From Baseline in the Composite Score of BME, Synovitis, and Tenosynovitis Assessed by PsAMRIS at Week 24 [ Time Frame: Baseline and week 24 ]

Locations (7)

FacilityCityStateZIPSite coordinators
The Doctors of Saint John's Medical GroupSanta MonicaCalifornia90404-
Inland Rheumatology Clinical Trials IncUplandCalifornia91786-
Malcom Randall VA Medical CenterGainesvilleFlorida32610-
Integral Rheumatology and Immunology SpecialistsPlantationFlorida33324-
NYU Langone Medical CenterNew YorkNew York10003-
Austin Regional ClinicAustinTexas78731-
Swedish Medical CenterSeattleWashington98104-

Find similar trials in Santa Monica, CA

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
The Doctors of Saint John's Medical Group· Santa Monica, CAInland Rheumatology Clinical Trials Inc· Upland, CAMalcom Randall VA Medical Center· Gainesville, FLIntegral Rheumatology and Immunology Specialists· Plantation, FLNYU Langone Medical Center· New York, NYAustin Regional Clinic· Austin, TX

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