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ABSTRACT: Background
In the present study, we explored the effects of immediate induction therapy with the anti-tumour necrosis factor (TNF)? antibody infliximab (IFX) plus methotrexate (MTX) compared with MTX alone and with placebo (PL) in patients with very early inflammatory arthritis.Methods
In an investigator-initiated, double-blind, randomised, placebo-controlled, multi-centre trial (ISRCTN21272423, http://www.isrctn.com/ISRCTN21272423 ), patients with synovitis of 12 weeks duration in at least two joints underwent 1 year of treatment with IFX in combination with MTX, MTX monotherapy, or PL randomised in a 2:2:1 ratio. The primary endpoint was clinical remission after 1 year (sustained for at least two consecutive visits 8 weeks apart) with remission defined as no swollen joints, 0-2 tender joints, and an acute-phase reactant within the normal range.Results
Ninety patients participated in the present study. At week 54 (primary endpoint), 32% of the patients in the IFX?+?MTX group achieved sustained remission compared with 14% on MTX alone and 0% on PL. This difference (p?ConclusionsThese results indicate that patients with early arthritis can benefit from induction therapy with anti-TNF plus MTX compared with MTX alone, suggesting that intensive treatment can alter the disease evolution.Trial registration
The trial was registered at http://www.isrctn.com/ISRCTN21272423 on 4 October 2007 (date applied)/12 December 2007 (date assigned). The first patient was included on 24 October 2007.
SUBMITTER: Stamm TA
PROVIDER: S-EPMC6085639 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
Stamm Tanja Alexandra TA Machold Klaus Peter KP Aletaha Daniel D Alasti Farideh F Lipsky Peter P Pisetsky David D Landewe Robert R van der Heijde Desiree D Sepriano Alexandre A Aringer Martin M Boumpas Dimitri D Burmester Gerd G Cutolo Maurizio M Ebner Wolfgang W Graninger Winfried W Huizinga Tom T Schett Georg G Schulze-Koops Hendrik H Tak Paul-Peter PP Martin-Mola Emilio E Breedveld Ferdinand F Smolen Josef J
Arthritis research & therapy 20180809 1
<h4>Background</h4>In the present study, we explored the effects of immediate induction therapy with the anti-tumour necrosis factor (TNF)α antibody infliximab (IFX) plus methotrexate (MTX) compared with MTX alone and with placebo (PL) in patients with very early inflammatory arthritis.<h4>Methods</h4>In an investigator-initiated, double-blind, randomised, placebo-controlled, multi-centre trial (ISRCTN21272423, http://www.isrctn.com/ISRCTN21272423 ), patients with synovitis of 12 weeks duration ...[more]