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

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ClinicalTrials.gov Identifier: NCT02778789
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Tocilizumab Drug: TNF-alpha Inhibitor

Detailed 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.
Study Design
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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Study Start Date : October 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Tocilizumab
Drug administration of Tocilizumab s.c. or i.v. depending on the preference of the patient and/or physician according to the label
 Drug: Tocilizumab
Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label
Other Name: RoActemra

Drug: TNF-alpha Inhibitor
Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label
Other Name: Adalimumab, Etanercept, Golimumab, Certolizumab-Pegol, Infliximab
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
 Drug: Tocilizumab
Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label
Other Name: RoActemra

Drug: TNF-alpha Inhibitor
Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label
Other Name: Adalimumab, Etanercept, Golimumab, Certolizumab-Pegol, Infliximab


Outcome Measures
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Primary Outcome Measures :
  1. Change in erosion volume in the HR-pQCT [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients (ages over 18 years) with the diagnosis of RA will be screened for the presence of erosions by Routine procedure with HR-pQCT. In case of a positive scan showing the presence of erosion in the wrist or the MCP Joints and after the decision of the treatment (if either Tocilizumab or TNF-Inhibitor), patients will be enrolled into the study.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778789


Locations
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Germany
University Erlangen-Nuremberg, Medical Department 3, Rheumatology & Immunology
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Georg Schett, Prof. Dr. univ. University of Erlangen-Nuremberg, Medical Department 3
More Information
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02778789    
Other Study ID Numbers: 1/4
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Necrosis
Pathologic Processes
Adalimumab
Etanercept
Golimumab
Infliximab
Certolizumab Pegol
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
 Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Tumor Necrosis Factor Inhibitors