Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT02778789
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label
  • TNF-alpha Inhibitor — DRUG
    Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label

Study Details

Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by performing a comprehensive analysis of the periarticular bone changes in RA patients treated with either TNFi or tocilizumab in a longitudinal Setting, using high-resolution peripheral quantitative computed tomography (HR-pQCT), a very sensitive method for visualizing and quantifying bone microstructure in RA patients. Quantitatively assessing the changes of erosions volume, osteophytes size and the area of cortical fenestration in a group of TNFi-treated and a group of tocilizumab- treated RA patients.

Key Dates

Start date
Oct 31, 2015
Status verified
Sep 2019
Primary completion
Sep 30, 2017
Completion
Mar 31, 2018

Study Design

Enrollment
66 participants (actual)

Arms

  • Arm: Tocilizumab
    Drug administration of Tocilizumab s.c. or i.v. depending on the preference of the patient and/or physician according to the label
  • Arm: TNF-alpha Inhibitor
    Drug administration s.c. or i.v. of the TNF-Alpha Inhibitor depending on the preference of the patient and/or physician according to the label

Primary Outcome Measure

Change in erosion volume in the HR-pQCT [ Time Frame: 12 months ]

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