The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial
of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients
with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate
alone is started. Golimumab will be discontinued.
Hypotheses:
First, the investigators hypothesize that initiation of a combination therapy with golimumab
+ MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the
percentage of patients achieving Disease Activity Score (the investigators hypothesize that
more patients with the early combination treatment will respond (according to Disease
Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response
Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal
Disease Activity (MDA) than patients on MTX alone.
Third, the investigators hypothesize that a significant proportion of the patients will
continue to benefit from this early aggressive treatment initiation even after stopping
golimumab treatment.
Phase:
Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)