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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum ( Amgen )
ClinicalTrials.gov Identifier:
NCT00111410
First received: May 20, 2005
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Anakinra (r-metHuIL-1ra)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • 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 Measures:
  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111410

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Swedish Orphan Biovitrum ( Amgen )
ClinicalTrials.gov Identifier: NCT00111410     History of Changes
Other Study ID Numbers: 20020101
Study First Received: May 20, 2005
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Swedish Orphan Biovitrum:
Rheumatoid Arthritis, Inflammation
Interleukin-1 (IL-1), r-metHuIL-1ra
Autoimmune, Kineret®
Anakinra, Immunex
Amgen, Clinical Trials

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014