Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 22 August 2016
• Main ID: NCT00111410
• Date of registration: 20/05/2005
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)
• Scientific 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)
• Date of first enrolment: August 2005
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00111410
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 4

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 74 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Anakinra (r-metHuIL-1ra)

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

20020101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors