NCT02065713View on ClinicalTrials.gov

Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Psoriatic Arthritis
Interventions
DRUG

Golimumab

Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.

DRUG

Methotrexate

MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity

DRUG

Placebo

The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.

Trial Locations (1)

Unknown

Centro Académico de Medicina de Lisboa, Lisbon

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Instituto de Medicina Molecular João Lobo Antunes

OTHER

NCT02065713 - Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients | Biotech Hunter | Biotech Hunter