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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00554606
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ACZ885 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
ACZ885
Drug: ACZ885
ACZ885


Outcome Measures

Primary Outcome Measures :
  1. • 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 ]

Secondary Outcome Measures :
  1. • 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554606


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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00554606     History of Changes
Other Study ID Numbers: CACZ885A2211
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs