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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00554606
First received: November 5, 2007
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: ACZ885
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • • Adverse events and infections • Vital signs and body measurements, hematology, blood chemistry, and urinalysis • Physical examination • Antinuclear antibody (ANA) assessment • Electrocardiogram (ECG) evaluation [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Response to treatment according to ACR20, ACR50, ACR70, and ACR90 and SDAI and DAS28. • Effect on ACR components. • Long-term immunogenicity. • Long-term pharmacokinetics of ACZ885. • Long term maintenance of health-related quality of life [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: October 2007
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ACZ885
Drug: ACZ885
ACZ885

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554606

  Show 51 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: NOVARTIS Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00554606     History of Changes
Other Study ID Numbers: CACZ885A2211
Study First Received: November 5, 2007
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Switzerland: Swissmedic
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health

Keywords provided by Novartis:
Rheumatoid Arthritis
Anit-interleukin-1 beta
ACZ885

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014