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Rheumatoid ArthritisPhase 4REPAIRNCT02765074

Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis

A Phase 4 study testing subcutaneous tocilizumab in people with Rheumatoid Arthritis, run by Centre Hospitalier Régional d'Orléans at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of several cytokines, which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
subcutaneous tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesFrance
Study dates
30 Jun 2016to 3 Apr 2025
Phase
Phase 4
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010 classification criteria
  • DAS 28 superior or equal to 3.2 despite DMARD or biological treatment (other than tocilizumab)
  • Superior or equal to one joint erosion at the right or left MCP 2, 3 on X-rays
  • Oral corticosteroid ≤ 10 mg/day prednisone or equivalent stable for at least one month
  • RA patients eligible to subcutaneous Tocilizumab monotherapy

Who cannot join

  • Treatment with zoledronic acid or denosumab (less than one year)
  • Intra-articular injection of corticosteroids at the MCP in the previous three months
  • Tocilizumab contra-indications in accordance with SPC (Summary of Product Characteristics) :Hypersensitivity to the active substance or to any of the excipients Active, severe infections including active tuberculosis Diverticulitis Active hepatic disease and hepatic Impairment including viral hepatitis Elevated Alanine Aminotransferase or Aspartate Aminotransferase >5×ULN Absolute neutrophil count < 0.5 × 10 exp 9 /L Platelet count < 50×10 exp 3 /μL,
  • General:
  • Absence of informed consent
  • Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Hopital Edouard HERIOT

    Lyon, 69437

  • CHR d'ORLEANS

    Orléans, 45067

  • Hopital Nord CHU de SAint ETIENNE

    Saint-Etienne

  • Chu Toulouse

    Toulouse

Other trials in France

About this study

Official title: Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study

Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of several cytokines, which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to detect early erosive changes and is unable to evaluate periarticular bone loss.

High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of cortical bone erosions, this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal antibody, developed and investigated in several clinical trials in RA. This biotherapy, in association with methotrexate (MTX) or given in monotherapy, is efficient in RA with inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically systemic inflammation, structural progression and improves clinical symptoms and quality of life.

Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.

Being tested
subcutaneous tocilizumab
Keywords
subcutaneous tocilizumab, High Resolution peripheral QCT (HR-pQCT), bone erosion, bone microarchitecture, rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • subcutaneous tocilizumabDrug

    Also called Roactemra

    162 mg subcutaneous, once a week during 12 months

Study groups in NCT02765074
Study groupRoleWhat they receive
RoactemraExperimentalsubcutaneous tocilizumab
Receives: Drug: subcutaneous tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone erosion change after 12 months of subcutaneous tocilizumab

    changes of width measured by HRpQCT.

    Measured: baseline and 12 months

  2. Bone erosion change after 12 months of subcutaneous tocilizumab

    changes of depth measured by HRpQCT.

    Measured: baseline and 12 months

  3. Bone erosion change after 12 months of subcutaneous tocilizumab

    changes of volume measured by HRpQCT.

    Measured: baseline and 12 months

Secondary outcomes (4)

  1. Associated factors with erosion changes assessed by HRqQCT

    Number of participants with associated factors with erosion changes by HRpQCT (Associated therapeutic, clinical and biological response )ultrasound ...)

    Measured: baseline, 3 months, 12 months

  2. Effect of 12 months of tocilizumab on bone density in the PR

    Changes of Bone mineral density by DXA at the lumbar spine and proximal femur

    Measured: baseline, 12 months

  3. Effect of Tocilizumab on synovitis/tenosynovitis assessed by US and agreement with disease activity scores

    Correlation Between clinical activity measured by various indices (Disease Activity Score 28, Clinical Disease Activity Iindex , Simplify Disease Activity Index , American College of Rheumatology - European League against Rheumatism: ACR EULAR) and ultrasound data.

    Measured: Predictors baseline, 1 and 3 months of clinical remission and / or ultrasound at 6 and 12 months

  4. Effect of 12 months of tocilizumab on bone microarchitecture in the PR

    changes of bone microarchitecture by tibia HRpQCT

    Measured: baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2016 (estimated)
  2. Study start30 Jun 2016
  3. Primary completion3 Apr 2025
  4. Study completion3 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02765074
Sponsor's protocol ID
CHRO 2014-03
Acronym
REPAIR
Status last verified
Apr 2025
First submitted
19 Apr 2016
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Boutroy S, Bouxsein ML, Munoz F, Delmas PD. In vivo assessment of trabecular bone microarchitecture by high-resolution peripheral quantitative computed tomography. J Clin Endocrinol Metab. 2005 Dec;90(12):6508-15. doi: 10.1210/jc.2005-1258. Epub 2005 Sep 27.

    PubMed 16189253

  • Stach CM, Bauerle M, Englbrecht M, Kronke G, Engelke K, Manger B, Schett G. Periarticular bone structure in rheumatoid arthritis patients and healthy individuals assessed by high-resolution computed tomography. Arthritis Rheum. 2010 Feb;62(2):330-9. doi: 10.1002/art.27252.

    PubMed 20112404

  • Fouque-Aubert A, Boutroy S, Marotte H, Vilayphiou N, Bacchetta J, Miossec P, Delmas PD, Chapurlat RD. Assessment of hand bone loss in rheumatoid arthritis by high-resolution peripheral quantitative CT. Ann Rheum Dis. 2010 Sep;69(9):1671-6. doi: 10.1136/ard.2009.114512. Epub 2010 Jun 4.

    PubMed 20525847

  • Ellouz R, Chapurlat R, van Rietbergen B, Christen P, Pialat JB, Boutroy S. Challenges in longitudinal measurements with HR-pQCT: evaluation of a 3D registration method to improve bone microarchitecture and strength measurement reproducibility. Bone. 2014 Jun;63:147-57. doi: 10.1016/j.bone.2014.03.001. Epub 2014 Mar 12.

    PubMed 24614646

  • Moller Dohn U, Boonen A, Hetland ML, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Moller JM, Ostergaard M. Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure. Ann Rheum Dis. 2009 Oct;68(10):1585-90. doi: 10.1136/ard.2008.097048. Epub 2008 Nov 19.

    PubMed 19019887

  • Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Stach C, Schett G. Repair of bone erosions in rheumatoid arthritis treated with tumour necrosis factor inhibitors is based on bone apposition at the base of the erosion. Ann Rheum Dis. 2011 Sep;70(9):1587-93. doi: 10.1136/ard.2010.148395. Epub 2011 May 27.

    PubMed 21622765

  • Dohn UM, Ostergaard M, Bird P, Boonen A, Johansen JS, Moller JM, Hansen MS. Tendency towards erosive regression on magnetic resonance imaging at 12 months in rheumatoid arthritis patients treated with rituximab. Ann Rheum Dis. 2009 Jun;68(6):1072-3. doi: 10.1136/ard.2008.098962. No abstract available.

    PubMed 19435723

  • Dohn UM, Ejbjerg B, Boonen A, Hetland ML, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Moller JM, Ostergaard M. No overall progression and occasional repair of erosions despite persistent inflammation in adalimumab-treated rheumatoid arthritis patients: results from a longitudinal comparative MRI, ultrasonography, CT and radiography study. Ann Rheum Dis. 2011 Feb;70(2):252-8. doi: 10.1136/ard.2009.123729. Epub 2010 Oct 26.

    PubMed 20980282

  • Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Schett G. Interleukin-6 receptor blockade induces limited repair of bone erosions in rheumatoid arthritis: a micro CT study. Ann Rheum Dis. 2013 Mar;72(3):396-400. doi: 10.1136/annrheumdis-2011-201075. Epub 2012 May 14.

    PubMed 22586162

  • Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.

    PubMed 20039425

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing subcutaneous tocilizumab in people with Rheumatoid Arthritis, run by Centre Hospitalier Régional d'Orléans at 4 sites in France.

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 5 inclusion and 6 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 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Bone erosion change after 12 months of subcutaneous tocilizumab (time frame: baseline and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02765074, which also lists 10 linked publications.

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 20 Apr 2025.

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