This study assessed 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Cologne, Germany
Novartis Investigator Site
Hamburg, Germany
Novartis Investigator Site
Leipzig, Germany
Adverse events and infections occurrence throughout the study.
Time frame: throughout the study
Presence of anti-ACZ885 antibodies in serum at baseline, Days 43, 71 and end of study (Day 113).
Time frame: throughout the study
ACR response criteria [including joint counts, patient/investigator disease activity and pain assessment, acute phase reactants (ESR and CRP) and a Health Assessment Questionnaire (HAQ)] .
Time frame: throughout the study
Disease Activity Score (DAS) at baseline and Days 43 and 113.
Time frame: throughout the study
Quantification of IL-1B, IL-6, and C-reactive protein (CRP), matrix metalloproteinases (MMPs) 1 and 3, and c-telopeptide of Type I collagen (Crosslaps), at Week 7 versus baseline.
Time frame: throughout the study
Serum concentrations of ACZ885 at each visit.
Time frame: throughout the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigator Site
Munich, Germany
Novartis Investigator Site
Ratingen, Germany
Novartis Investigator Site
Leiden, Netherlands
Novartis Investigator Site
Nijmegen, Netherlands
Novartis Investigator Site
Bern, Switzerland
Novartis Investigator Site
Geneva, Switzerland