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

First listed
May 20, 2016
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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