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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:
ClinicalTrials.gov Identifier:
NCT00111410
First Posted: May 23, 2005
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Swedish Orphan Biovitrum ( Amgen )
  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
Intervention Model: Parallel Assignment
Masking: Double
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 ( Amgen ):

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

Study Completion Date: November 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111410


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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111410     History of Changes
Other Study ID Numbers: 20020101
First Submitted: May 20, 2005
First Posted: May 23, 2005
Last Update Posted: August 11, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents