Clinical trial NCT00111410: Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)
Official title: A Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Estimate the Effect of Anakinra (r-metHuIL-1ra) on Vaccine Antibody Response in Subjects With Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Inflammation
Interleukin-1 (IL-1), r-metHuIL-1ra
Autoimmune, Kineret®
Anakinra, Immunex
Amgen, Clinical Trials
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2005-05-23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Anti-tetanus antibody titers at weeks 4 and 8
measure: Anti-tetanus antibody level changes from baseline to week 4
measure: Anti-tetanus antibody level changes from week 4 to week 8
measure: Antibody level of at least 0.1 IU/mL at week 8.
measure: Safety evaluation of serious adverse events, adverse events and laboratory assessments
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: