Clinical trial NCT00117091: Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)
Official title: An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
Anakinra (Kineret®)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: % of subjects continuing Kineret® therapy at the end of the study (I.e., responders according to pre-defined response assessment criteria.)
Secondary outcomes:
measure: Change in Health Related Quality of Life (HRQOL) scores at the end of study weeks 12, 24, 36 and 48.
measure: feasibility of simpleject device
measure: treatment response (ACR scores, DAS 28) at the end of study weeks 12, 24, 36 and 48.
measure: Safety of Kineret® when added to current DMARD therapy.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: