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Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an α4 integrin antagonist, in combination with methotrexate, versus methotrexate alo...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-004022-27

Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an α4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate

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Extrait

1. To determine the efficacy of RO0506997 (a dual α4 integrin [VCAM1] antagonist) in combination with methotrexate, in adult patients with rheumatoid arthritis (RA) who currently exhibit a partial clinical response to their existing methotrexate therapy. 2. To determine the safety of RO0506997 (a dual α4 integrin [VCAM1] antagonist) in combination with methotrexate, in adult patients with rheumatoid arthritis (RA). 3. To explore the pharmacokinetics (PK) of RO0506997 (in combination with methotrexate) in this population of patients, utilising a population pharmacometric approach. 4. To explore the pharmacodynamics (PD) of RO0506997 (in combination with methotrexate) in this population of patients.

Critère d'inclusion

  • Rhematoid Arthritis

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