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A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to me...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-002392-32

A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis

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Extrait

1. To determine the efficacy and safety at week 24 of rituximab 500 mg i.v. x2 and rituximab 1000 mg i.v. x2 when used in combination with MTX compared to continued MTX monotherapy in patients with active rheumatoid arthritis that currently have an inadequate clinical response to MTX. 2. To investigate by a population analysis approach the pharmacokinetics (PK) of rituximab in the target RA patient population and the influence of covariates on the PK parameters. 3. To explore the long-term efficacy and safety of further courses of rituximab.

Critère d'inclusion

  • active rheumatoid arthritis

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