University Erlangen-Nuremberg, Medical Department 3, Rheumatology & Immunology
Erlangen, 91054, Germany
NCT Number: NCT02778789
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Erlangen, 91054, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label
Other names: RoActemra
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
Time frame: 12 months
Time frame: 12months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
University of Erlangen-Nürnberg Medical School
Other
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
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.
NCT03649178
Arthritis, Arthritis, Rheumatoid
Nashville, Tennessee, United States
View Trial DetailsNCT03025308
Arthritis, Arthritis, Rheumatoid
Huntsville, Alabama, United States
View Trial DetailsNCT07715045
Arthritis, Arthritis, Rheumatoid
Palembang, South Sumatera, Indonesia
View Trial DetailsNCT00055055
Arthritis, Arthritis, Rheumatoid
Bethesda, Maryland, United States
View Trial Details