Clinical Trial: Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Multicenter, International, Open-label Study of Infliximab Plus Methotrexate Versus Methotrexate (MTX) Alone for the Treatment of MTX naïve Subjects With Active >=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.



Original Primary Outcome:

Current Secondary Outcome:

  • Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable [ Time Frame: between baseline and week 16 ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
  • Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ) [ Time Frame: between baseline and week 16 ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
  • Adverse Events [ Time Frame: between baseline and week 16 ]
    This is not a prespecified key secondary outcome; therefore, results will not be disclosed.


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: August 18, 2006
Date Started: May 2006
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017