NCT00487825

Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

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 Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab (investigational)	Canakinumab was supplied in 6 mL colorless glass vials each containing nominally 150 mg canakinumab (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
DRUG	Placebo	Matching placebo was supplied in form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
DRUG	Methotrexate (MTX)	Methotrexate (MTX) was supplied in tablet form, each of 2.5 mg strength.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-06-19
• Last updated: 2012-08-01
• Results posted: 2011-05-06

Locations

22 sites across 6 countries: United States, Belgium, Germany, Italy, Netherlands, Spain