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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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)

Study chairs or principal investigators

Willard Dere, M.D.,  Study Chair,  Amgen   

Study ID Numbers:  20020364
Record last reviewed:  June 2005
Last Updated:  July 1, 2005
Record first received:  July 1, 2005
ClinicalTrials.gov Identifier:  NCT00117091
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-07-05