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

Rheumatoid Arthritis Clinical Trial

— Re-Bone  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778789
• Other study ID #: 1/4
• Status: Completed
• Start date: October 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: September 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 31, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Germany	University Erlangen-Nuremberg, Medical Department 3, Rheumatology & Immunology	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in erosion volume in the HR-pQCT		12 months
Secondary	Change in the Disease activity score 28 (DAS28)		12months
Secondary	Change in the Clinical Disease Activity Index (CDAI)		12 months
Secondary	Changes in the Simple Disease Activity Index (SDAI)		12 months
Secondary	Change in the Health Assessment Questionnaire (HAQ)		12 months
Secondary	Number of patients in Remission (DAS28 < 2.6)		12 months
Secondary	Number of patients in Low Disease Activity (DAS28 = 2.6 und = 3.2)		12 months