Mobile

PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXAT...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-008338-35

PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Femme et Homme

  • | Pays :
    • -
  • | Organes :
    • -
  • | Spécialités :
    • -

Extrait

There are four primary objectives, to be assessed in the following sequence: 1. To compare the efficacy of CP-690,550 in doses of 5 mg BID and 10 mg BID versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in patients with active RA on a stable background of methotrexate, as measured by ACR20 response rates at Month 6. 2. To compare physical function status of patients after administration of 5 mg BID and 10 mg BID of CP-690,550 versus placebo using the HAQ-DI at Month 3 compared to baseline in patients with active RA on a stable background of methotrexate. 3. To compare the rate of achieving DAS28-4(ESR)<2.6 at Month 6 after administration of 5 mg BID and 10 mg BID of CP-690-550 versus placebo in patients with active RA on stable background methotrexate. 4. To evaluate the safety and tolerability over 12 months of CP-690,550 in doses of 5 mg BID and 10 mg BID versus placebo in patients with active RA on a stable background of methotrexate.

Critère d'inclusion

  • CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults

Liens