NCT00504595

Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis

A 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ACZ885 (investigational)	The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (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 of ACZ885 was supplied in the 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.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-07-20
• Last updated: 2012-08-07
• Results posted: 2011-06-23

Locations

4 sites across 4 countries: Russia, Spain, Switzerland, Turkey (Türkiye)