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A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in met...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-002395-15

A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis

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Extrait

1. To determine the efficacy of rituximab in the prevention of progression in structural joint damage and to evaluate the safety of rituximab in patients with active rheumatoid arthritis initiating treatment with MTX. 2. To evaluate the efficacy of rituximab in improving patient’s physical function and signs and symptoms of RA. 3. 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. 4. To explore the long-term efficacy and safety of further courses of rituximab.

Critère d'inclusion

  • Rheumatoid Arthritis

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