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

NCT02778789 | Completed

• 1 other identifier: 1/4
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in erosion volume in the HR-pQCT

  12 months

Secondary Outcomes (6)

• Change in the Disease activity score 28 (DAS28)

  12months

• Change in the Clinical Disease Activity Index (CDAI)

  12 months

• Changes in the Simple Disease Activity Index (SDAI)

  12 months

• Change in the Health Assessment Questionnaire (HAQ)

  12 months

• Number of patients in Remission (DAS28 < 2.6)

  12 months

Study Arms (2)

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; Drug: TNF-alpha Inhibitor

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; Drug: TNF-alpha Inhibitor

Interventions

Tocilizumab DRUG

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

Also known as: RoActemra

TNF-alpha Inhibitor; Tocilizumab

TNF-alpha Inhibitor DRUG

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

Also known as: Adalimumab, Etanercept, Golimumab, Certolizumab-Pegol, Infliximab

TNF-alpha Inhibitor; Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Adalimumab; Etanercept; golimumab; Certolizumab Pegol; Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments

Study Officials

• Georg Schett, Prof. Dr. univ.

  University of Erlangen-Nuremberg, Medical Department 3

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 20, 2016
• Study Start: October 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: March 31, 2018
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

DE (1)