Clinical trial

Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in…

NCT00487825 · Novartis, Industry · Completed

Key facts

NCT number NCT00487825
Title Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
Official title A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis…
Lead sponsor Novartis, Industry
Status Completed
Phase Phase 2
Study type Interventional
Conditions Rheumatoid Arthritis
Intervention type Drug
Interventions Canakinumab (investigational), Placebo, Methotrexate (MTX)
Enrollment 78
Start date Mar 1, 2007
Primary completion Dec 1, 2008
Completion Dec 1, 2008
First posted Jun 19, 2007
Last update posted Aug 1, 2012
Countries Belgium, Germany, Italy, Netherlands, Spain, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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