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

November 5, 2007
May 1, 2012
October 2007
August 2009   (final data collection date for primary outcome measure)
• 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 ]
• 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 ]
Complete list of historical versions of study NCT00554606 on ClinicalTrials.gov Archive Site
• 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 ]
• 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 ]
Not Provided
Not Provided
 
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: ACZ885
ACZ885
Experimental: 1
ACZ885
Intervention: Drug: ACZ885
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
Not Provided
August 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Germany,   Italy,   Netherlands,   Russian Federation,   Spain,   Switzerland,   Turkey
 
NCT00554606
CACZ885A2211
No
Novartis
Novartis
Not Provided
Principal Investigator: NOVARTIS Novartis investigator site
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP