Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013