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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)