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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00505089 |
This study will investigate the pharmacokinetic (PK) / total IL-1beta pharmacodynamic (PD) relationship in joint fluids of patients with rheumatoid arthritis (RA) treated with different doses of ACZ885 and to evaluate the impact of the subcutaneous (s.c.) versus intravenous (i.v.) route of administration.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: ACZ885 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Exploratory, Open Label Pharmacokinetic - Pharmacodynamic Study to Compare Subcutaneous Versus Intravenous Administration of ACZ885 in Adult Patients With Established Rheumatoid Arthritis |
Enrollment: | 11 |
Study Start Date: | August 2007 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
ACZ885 10mg/kg subcutaneous
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Drug: ACZ885 |
2: Experimental
ACZ885 5mg/kg intravenous
|
Drug: ACZ885 |
3: Experimental
ACZ885 2mg/kg subcutaneous
|
Drug: ACZ885 |
4: Experimental
ACZ885 1mg/kg intravenous
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Drug: ACZ885 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Previous treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate or tacrolimus. The following washout period will be required for such patients to be eligible to participate in the trial.
Other protocol-defined inclusion/exclusion criteria may apply
Belgium | |
Novartis Investigative site | |
Antwerp, Belgium | |
Novartis Investigator Site | |
Liege, Belgium | |
Germany | |
Novartis Investigative site | |
Berlin, Germany | |
Novartis Investigator Site | |
Berlin, Germany | |
Novartis Investigator Site | |
Hannover, Germany | |
Novartis Investigator Site | |
Leipzig, Germany | |
Netherlands | |
Novartis investigative site | |
Leiden, Netherlands | |
Poland | |
Novartis Investigative Site | |
Grodzisk Mazowiecki, Poland | |
Novartis Investigator Site | |
Poznan, Poland |
Principal Investigator: | Novartis | Investigative site |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CACZ885A2206 |
Study First Received: | July 19, 2007 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00505089 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
pharmacokinetic, pharmacodynamic, subcutaneous, intravenous, ACZ885, patients, rheumatoid, arthritis. |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |