Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.

Key facts

Study ID

NCT00554606

Run by

Novartis

People needed

115

Starts

2007-10-11

Expected to finish

2009-08-13

Last updated by the study team

2021-07-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent

You may not qualify if…

• 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 study.
• Patients who did not complete / discontinued from the core study.
• Patients with drug related serious adverse events or severe adverse events.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigator Site — Tuscaloosa, Alabama, United States
• Novartis Investigator Site — Paradise Valley, Arizona, United States
• Novartis Investigator Site — Trumbull, Connecticut, United States
• Novartis Investigator Site — Jacksonville, Florida, United States
• Novartis Investigator Site — South Miami, Florida, United States
• Novartis Investigator Site — Tamarac, Florida, United States
• Novartis Investigator Site — Rockford, Illinois, United States
• Novartis Investigator Site — Urbandale, Indiana, United States
• Novartis Investigator Site — Richmond Heights, Missouri, United States
• Novartis Investigator Site — Omaha, Nebraska, United States
• Novartis Investigator Site — Reno, Nevada, United States
• Novartis Investigator Site — Tulsa, Oklahoma, United States
• Novartis Investigator Site — Austin, Texas, United States
• Novartis Investigator Site — Carrollton, Texas, United States
• Novartis Investigator Site — Dallas, Texas, United States
• Novartis Investigator Site — Fort Worth, Texas, United States
• Novartis Investigator Site — Mesquite, Texas, United States
• Novartis Investigator Site — Arlington, Virginia, United States
• Novartis Investigator Site — Spokane, Washington, United States
• Novartis Investigator Site — Antwerp, Belgium
• Novartis Investigator Site — Diepenbeek, Belgium
• Novartis Investigator Site — Liège, Belgium
• Novartis Investigator Site — Berlin, Germany
• Novartis Investigator Site — Hamburg, Germany
• Novartis Investigator Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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