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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACZ885 | Drug |
| ||
| ACZ885 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and infections occurrence throughout the study. | throughout the study | |
| Presence of anti-ACZ885 antibodies in serum at baseline, Days 43, 71 and end of study (Day 113). | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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)] . | throughout the study | |
| Disease Activity Score (DAS) at baseline and Days 43 and 113. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Berlin | Germany | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18534016 | Derived | Alten R, Gram H, Joosten LA, van den Berg WB, Sieper J, Wassenberg S, Burmester G, van Riel P, Diaz-Lorente M, Bruin GJ, Woodworth TG, Rordorf C, Batard Y, Wright AM, Jung T. The human anti-IL-1 beta monoclonal antibody ACZ885 is effective in joint inflammation models in mice and in a proof-of-concept study in patients with rheumatoid arthritis. Arthritis Res Ther. 2008;10(3):R67. doi: 10.1186/ar2438. Epub 2008 Jun 5. |
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|
| 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. | throughout the study |
| Serum concentrations of ACZ885 at each visit. | throughout the study |
| Cologne |
| Germany |
| Novartis Investigator Site | Hamburg | Germany |
| Novartis Investigator Site | Leipzig | Germany |
| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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