Clinical trial

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With…

NCT00299130 · Genentech, Inc., Industry · Completed

Key facts

NCT number NCT00299130
Title A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
Official title A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis
Acronym SERENE
Lead sponsor Genentech, Inc., Industry
Collaborators Hoffmann-La Roche Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Rheumatoid Arthritis
Intervention type Drug
Interventions Folate, Methotrexate, Methylprednisolone, Placebo, Rituximab
Enrollment 511
Start date Oct 1, 2005
Primary completion Jun 1, 2008
Completion Jul 1, 2013
First posted Mar 6, 2006
Last update posted Apr 17, 2017

At a glance

  • 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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