anakinra (kineret®) in combination with disease modifying anti-rheumatic drugs (dmards) in subjects with active rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: 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.


Eligibility 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)

Keywords: rheumatoid arthritis ra anakinra (kineret®)