Conditions: Arthritis, Psoriatic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 115
Healthy volunteers: no

Brief summary:
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.

Detailed description:

Arms:
arm 1: Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week arm 2: Oral methotrexate (MTX) 15 mg/week

Interventions: intervention 1: Infliximab + methotrexate (IFX + MTX) intervention 2: Methotrexate (MTX)
Intervention descriptions: intervention 1: Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6. intervention 2: Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.

Protocol document: