Rheumatoid ArthritisRe-BoneNCT02778789
Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers
An observational study of Rheumatoid Arthritis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab and TNF-alpha Inhibitor
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Erlangen-Nuremberg, Medical Department 3, Rheumatology & Immunology
Erlangen, 91054
About this study
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.
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab, TNF-alpha Inhibitor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra
Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label
TNF-alpha InhibitorDrug
Also called Adalimumab, Etanercept, Golimumab, Certolizumab-Pegol, Infliximab
Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Drug administration of Tocilizumab s.c. or i.v. depending on the preference of the patient and/or physician according to the label Receives: 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 Receives: Drug: Tocilizumab; Drug: TNF-alpha Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erosion volume in the HR-pQCT
Measured: 12 months
Secondary outcomes (6)
Change in the Disease activity score 28 (DAS28)
Measured: 12months
Change in the Clinical Disease Activity Index (CDAI)
Measured: 12 months
Changes in the Simple Disease Activity Index (SDAI)
Measured: 12 months
Change in the Health Assessment Questionnaire (HAQ)
Measured: 12 months
Number of patients in Remission (DAS28 < 2.6)
Measured: 12 months
Number of patients in Low Disease Activity (DAS28 ≥ 2.6 und ≤ 3.2)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startOct 2015
- Primary completion30 Sep 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schett, Prof. Dr. univ., Principal investigator, University of Erlangen-Nuremberg, Medical Department 3
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778789
- Sponsor's protocol ID
- 1/4
- Acronym
- Re-Bone
- Status last verified
- Sep 2019
- First submitted
- 16 May 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02778789
- Acronym / sponsor ID
- Re-Bone / 1/4
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | – | Drug: Tocilizumab, Drug: TNF-alpha InhibitorDrug administration of Tocilizumab s.c. or i.v. depending on the preference of the patient and/or physician according to the label |
| TNF-alpha Inhibitor | – | Drug: Tocilizumab, Drug: TNF-alpha InhibitorDrug 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RoActemraPatients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label | Drug | TNF-alpha Inhibitor, Tocilizumab |
| TNF-alpha InhibitorAlso: Adalimumab, Etanercept, Golimumab, Certolizumab-Pegol, InfliximabPatients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label | Drug | TNF-alpha Inhibitor, Tocilizumab |
Primary outcome
Change in erosion volume in the HR-pQCT
Time frame: 12 months
6 secondary outcomes
Change in the Disease activity score 28 (DAS28)
Time frame: 12months
Change in the Clinical Disease Activity Index (CDAI)
Time frame: 12 months
Changes in the Simple Disease Activity Index (SDAI)
Time frame: 12 months
Change in the Health Assessment Questionnaire (HAQ)
Time frame: 12 months
Number of patients in Remission (DAS28 < 2.6)
Time frame: 12 months
Number of patients in Low Disease Activity (DAS28 ≥ 2.6 und ≤ 3.2)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Schett, Prof. Dr. univ. principal investigator
University of Erlangen-Nuremberg, Medical Department 3
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erosion volume in the HR-pQCT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.