At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
In Brief
A Phase 3 clinical trial evaluating golimumab and Placebo; golimumab for Arthritis, Psoriatic. Completed, enrolled 407 participants across 51 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.
Study Details
Timeline
Interventions
50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg
SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg
100 mg sc injections every 4 wks from wk 0 up to 5 yrs