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The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: Results of a phase IIB randomized, double‐blind, placebo‐controlled, dose‐ranging trial

Arthritis & Rheumatism · 2006 · Vol. 54(5) · pp. 1390–1400

Paul Emery✉(Chapel Allerton Hospital)Roy Fleischmann(The University of Texas Southwestern Medical Center)Anna Filipowicz‐Sosnowska(National Institute of Geriatrics, Rheumatology and Rehabilitation)Joy SchechtmanL SzczepańskiArthur Kavanaugh(University of California, San Diego)Artur Racewicz(University Clinical Hospital In Bialystok)Ronald van Vollenhoven(Karolinska University Hospital)Nicole F. LiSunil AgarwalE. Hessey(Roche (United Kingdom))T Shaw(Roche (United Kingdom))

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Abstract

Both rituximab doses were effective and well tolerated when added to MTX therapy in patients with active RA. The primary end point (ACR20 response) was independent of glucocorticoids, although intravenous glucocorticoid premedication improved tolerability during the first rituximab infusion.

Rheumatoid Arthritis Research and Therapies Chronic Lymphocytic Leukemia Research Lymphoma Diagnosis and TreatmentMedicineRheumatoid arthritisRituximabPlaceboMethylprednisoloneInternal medicineRheumatologyPremedicationRheumatismMethotrexate

MeSH terms

RituximabAntibodies, MonoclonalArthritis, RheumatoidDouble-Blind MethodDrug ResistanceDrug Therapy, CombinationFemaleGlucocorticoidsHumansImmunologic FactorsMaleMethotrexateMiddle AgedSafetyAntirheumatic Agents

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Efficacy and safety of rituximab in moderately‐to‐severely active systemic lupus erythematosus: The randomized, double‐blind, phase ii/iii systemic lupus erythematosus evaluation of rituximab trial