Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Inflammation, Interleukin-1 (IL-1), r-metHuIL-1ra, Autoimmune, Kineret®, Anakinra, Immunex, Amgen, Clinical Trials
Brief summary
The purpose of this study is to estimate the effect of anakinra, 100 mg once daily (QD), on the development of an anti-tetanus antibody response in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection. In addition, this study will evaluate the general safety profile of therapy with anakinra, 100 mg QD, in subjects with RA after vaccination with a tetanus and diphtheria toxoids injection.
Interventions
DRUGAnakinra (r-metHuIL-1ra)
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosed with RA by American College of Rheumatology (ACR) criteria for greater than or equal to 12 weeks - Active RA with at least 3 swollen joints and 3 tender/painful joints and at least one of the following: * Morning stiffness greater than or equal to 45 minutes; * C-reactive protein (CRP) greater than or equal to 1.5 mg/dL; * Erythrocyte sedimentation rate greater than or equal to 28 mm/hr; * Stable methotrexate dose of less than or equal to 20 mg/week for 8 weeks prior to randomization; * Stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to 10 mg/day of prednisone or equivalent) for 4 weeks prior to randomization.
Exclusion criteria
- Pregnant or breast-feeding women - Any uncontrolled, clinically significant systemic disease - Has total white cell count less than 3.5 x 10\^9/L, a neutrophils count less than 2.0 x 10\^9/L, platelet count less than 125 x 10\^9/L or hemoglobin (Hgb) less than 8.0 g/dL at screening - Abnormal liver function tests (AST/ALT greater than or equal to 1.5 x the upper limit of normal at screening) - Serum creatinine greater than 1.5 x the upper limit of normal at screening - Subject recall of having tetanus toxoid or diphtheria vaccination less than 10 years prior to randomization - Has never received a primary tetanus vaccination - Any other vaccination within 12 weeks of randomization - Disease-modifying antirheumatic drugs (DMARDs) other than methotrexate - Biologics to treat RA within the previous 8 weeks of screening (e.g., etanercept, infliximab) - Subjects were treated with anakinra within 4 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects that achieve an anti-tetanus antibody response rate at study week 8 (4 weeks after the tetanus injection), based on a 4-fold titer development relative to week 4 (pre-vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tetanus antibody titers at weeks 4 and 8 | — |
| Anti-tetanus antibody level changes from baseline to week 4 | — |
| Anti-tetanus antibody level changes from week 4 to week 8 | — |
| Antibody level of at least 0.1 IU/mL at week 8. | — |
| Safety evaluation of serious adverse events, adverse events and laboratory assessments | — |
Outcome results
None listed