NCT00111410

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2005

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

First QC Date

May 20, 2005

Last Update Submit

August 10, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, InflammationInterleukin-1 (IL-1), r-metHuIL-1raAutoimmune, Kineret®Anakinra, ImmunexAmgen, Clinical Trials

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • 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

Interventions

Anakinra (r-metHuIL-1ra)DRUG

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2005

First Posted

May 23, 2005

Study Completion

November 1, 2003

Last Updated

August 11, 2016

Record last verified: 2016-08