A Multicenter, Randomized, Double-Period, Double − Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis

Femme et Homme

| Pays :
| Organes :
| Spécialités :

Extrait

The objective of this study is to assess and compare the proportion of subjects who achieve low disease activity as defined by both a clinical response (DAS28<3.2) and no radiographic progression (∆mTSS<0.5) at week 78 (among those subjects who responded at Weeks 22 and 26, i.e., DAS28 <3.2) in subjects treated with adalimumab/MTX (combination therapy) for 78 weeks (Arm 2) and subjects treated with placebo/MTX (monotherapy) for 78 weeks (Arm 4). Subjects who did not achieve a clinical response (DAS <3.2) at Week 22 or 26 were not allowed to continue on their current treatment and were given open-label combination therapy (adalimumab and MTX) for the remeinder of the study under ethical consideration. This study is also designed to evaluate the maintenance of clinical response in a population of subjects initially treated with combination therapy but subsequently with methotrexate monotherapy by discontinuing adalimumab (HUMIRA®), the TNF antagonist).

Critère d'inclusion

Rheumatoid Arthritis

Kusajili – Centralise les essais cliniques mondiaux

A Multicenter, Randomized, Double-Period, Double − Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rh...