Skip to main content
OpenTrials
Completed

NCT Number: NCT02778789

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Erlangen-Nuremberg, Medical Department 3, Rheumatology & Immunology

Erlangen, 91054, Germany

About this study

Inhibition of tumor necrosis factor alpha (TNF-α) and of interleukin- 6 receptor (IL-6R) emerged as highly effective cytokine blocking strategies in the treatment of rheumatoid arthritis (RA) in the last years. Both, inhibition of TNF-α (TNFi) and of the interleukin-6 receptor by tocilizumab ameliorate the signs and symptoms, reverse the elevated acute phase response and inhibit the progression of bone erosion in RA patients (1). Despite striking similarities with respect to their efficacy and safety in the treatment of RA, TNFi and tocilizumab are two entirely distinct approaches for targeting chronic inflammatory diseases in humans. This concept is highlighted by the differential response to TNFi and tocilizumab in other chronic inflammatory diseases such as psoriasis, psoriatic arthritis and spondyloarthritis, with clinical efficacy of the former but not the latter treatment modality (2). On the other hand, tocilizumab has a direct effect on the acute phase response and iron metabolism, which is not found with TNFi. Therefore, subtle differences may exist between TNFi and tocilizumab, which are relevant for the long-term treatment of RA patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females and males with RA erosions in the wrist and/or MCP joints
  • Must be aged ≥ 18 years at time of consent
  • Stable treatment with conventional DMARDs of at least 3 months

Exclusion criteria

  • Patients exposed to abatacept or rituximab in the last 12 months
  • Patients receiving glucocorticoids over 5 mg prednisolone per day
  • Patients who are younger than 18 years
  • Pregnant or lactating females
  • Patients having received an HR-pQCT examination during the last 6 months before screening

Treatment and study plan

Tocilizumab

Drug

Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label

Other names: RoActemra

TNF-alpha Inhibitor

Drug

Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label

Other names: Adalimumab, Etanercept, Golimumab, Certolizumab-Pegol, Infliximab

Primary outcomes

  1. Change in erosion volume in the HR-pQCT

    Time frame: 12 months

Secondary outcomes

  1. Change in the Disease activity score 28 (DAS28)

    Time frame: 12months

  2. Change in the Clinical Disease Activity Index (CDAI)

    Time frame: 12 months

  3. Changes in the Simple Disease Activity Index (SDAI)

    Time frame: 12 months

  4. Change in the Health Assessment Questionnaire (HAQ)

    Time frame: 12 months

  5. Number of patients in Remission (DAS28 < 2.6)

    Time frame: 12 months

  6. Number of patients in Low Disease Activity (DAS28 ≥ 2.6 und ≤ 3.2)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers.

Acronym: Re-Bone

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 20, 2016
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.