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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00117091 |
Purpose
The purpose of this study is to evaluate the percentage of subjects in Australian clinical practice continuing treatment with Anakinra (Kineret®) at the end of study week 48 in subjects with active RA. The continued use of Kineret® will be based on pre-defined response assessment criteria for subjects with active RA.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Anakinra (Kineret®) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Subjects diagnosed with RA as determined by American College of Rheumatology (ACR) criteria with a disease duration of at least 24 weeks prior to enrollment - Active RA at screening as defined by EITHER: (1) At least 6 swollen joints (using a 66 joint count) and at least 6 tender joints (using a 68 joint count) OR (2) 4 non-hand joints and at least 1 of the following: *Morning stiffness of at least 45 minutes; *CRP greater than 1.5 mg/dL (15.0 mg/L); *ESR greater than 28 mm/h; *DAS28 greater than 3.2 - Subjects must have failed an adequate trial of at least 3 disease-modifying antirheumatic drugs (DMARDS) alone or in combination (one of which must be MTX) and have been on the same treatment and doses for 4 weeks prior to enrollment (i.e., an adequate trial is defined as 12 weeks unless limited by toxicity or intolerance) - Subjects' doses of nonsteroidal antiinflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to 10 mg/day of prednisone or equivalent) must have been kept stable for 4 weeks prior to enrollment.
Doses of 10 mg/day prednisone or equivalent should not be exceeded during the study Exclusion Criteria: - ACR functional class IV or ARA anatomical stage IV - Subjects that are scheduled for surgery or being evaluated for surgery for hands, wrist and feet - Felty's syndrome - Any poorly controlled, clinically significant systemic disease (e.g., chronic obstructive pulmonary disease, congestive heart failure, stroke, chronic renal failure, liver disease) - Poorly controlled diabetes mellitus (e.g., diabetics with HbA1C greater than 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders) - Malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past 5 years - Abnormal chest x-ray that is clinically significant or bronchiectasis - Within 12 weeks before date of enrollment any of the following occurrences: presence of serious infection (e.g., requiring hospitalization and/or IV antibiotics), frequent, acute, or chronic infections - History of chronic infection - Recent history (within 24 weeks of enrollment) of drug or alcohol abuse - Known to be positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus - Presence of any condition that may compromise the ability of the subject to give informed consent - Planned events (e.g., planned hospitalizations, vacations, etc.) that would interfere with the collection of the required assessments and/or may prevent the subject from completing the study according to protocol - White cell count less than or equal to 3.5 x 10^9/L, a neutrophil count of less than or equal to 2.5 x 10^9/L, or platelet count of less than or equal to 125 x 10^9/L at screening - Hemoglobin less than or equal to 8.0 g/dL at screening - Elevated AST or ALT greater than or equal to 1.5 x the upper limit of normal at screening - Elevated serum creatinine greater than or equal to 1.5 x the upper limit of normal at screening - Received intra-articular or systemic corticosteroid injections within 4 weeks before enrollment - Subjects who have received previous treatment with anti-IL-1ra or anti-TNF therapies (e.g., anakinra, etanercept or infliximab) within 4 weeks prior to enrollment - Subjects who are pregnant or breast-feeding, or plan to become pregnant during the course of the study - Subject (man or woman) is of child bearing potential and not using adequate contraceptive precautions - Known allergy to E. coli derived products - Receiving or has received any investigational drug within the previous 30 days or within 5 half-lives of any investigational drug, whichever is greater (or is currently using an investigational device)
Contacts and Locations
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20020364 |
| Study First Received: | June 30, 2005 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00117091 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Rheumatoid Arthritis RA Anakinra (Kineret®) |
|
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Therapeutic Uses Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Interleukin 1 Receptor Antagonist Protein Rheumatic Diseases Antirheumatic Agents Pharmacologic Actions |