Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00471198

Purpose

This 76-week extension study is designed to collect long-term safety and tolerability data with 300 mg ACZ885 in patients with active rheumatoid arthritis (RA) who participated in the core CACZ885A2201 study. The study will investigate the efficacy by assessing the response to treatment according to American College Rheumatolgy criteria.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: ACZ885	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 76-Week, Open-Label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-Interleukin-1 Beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety assessed by adverse events and laboratory values

Secondary Outcome Measures:

Efficacy assessed by American College Rheumatolgy criteria (ACR50, ACR20 and ACR70) and, Disease Activity Score (DAS) 28
Assessment of the effect of ACZ885 on ACR components, including marker of inflammation (hsCRP)
Immunogenicity of ACZ885 assessment after 76 weeks of repeat exposure

Estimated Enrollment:	208
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ACZ885

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

• Patients who completed the core CACZ885A2201 study may enter the extension study upon signing informed consent.

Exclusion Criteria:

Patients for whom continued treatment in the extension is not considered appropriate by the treating physician
Patients who were non-compliant or who demonstrated a major protocol violation in the core CACZ885A2201 study

Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471198

Locations

United States, Alabama
Novartis Investigative Site
Anniston, Alabama, United States, 36207
United States, Arizona
Novartis Investigative Site
Tucson, Arizona, United States, 85704
Novartis Investigative Site
Peoria, Arizona, United States, 85381
United States, Florida
Novartis Investigative Site
Palm Harbor, Florida, United States, 34684
United States, Illinois
Novartis Investigative Site
Springfield, Illinois, United States, 62704
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63128
United States, New York
Novartis Investigative Site
Albany, New York, United States, 12206
Novartis Investigative Site
Rochester, New York, United States, 14618
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97239
United States, Washington
Novartis Investigative Site
Tacoma, Washington, United States, 98405
Austria
Novartis Investigative Site
Innsbruck, Austria
Belgium
Novartis Investigative Site
Brussels, Belgium
Canada
Novartis Investigative Site
Quebec City, Canada
Germany
Novartis Investigative Site
Berlin, Germany
Spain
Novartis Investigative Site
Sevilla, Spain

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CACZ885A2201E1
Study First Received:	May 7, 2007
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00471198
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; United States: Food and Drug Administration

Keywords provided by Novartis:

Active Rheumatoid Arthritis
Anti-interleukin-1 beta monoclonal antibody
Methotrexate

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009