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

June 14, 2023 updated by: Centre Hospitalier Régional d'Orléans

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69437
        • Recruiting
        • Hôpital Edouard Hériot
        • Principal Investigator:
          • CHAPURLAT Roland, PUPH
      • Orleans, France, 45067
        • Recruiting
        • CHR d'Orléans
        • Principal Investigator:
          • SALLIOT Carine
      • Saint Etienne, France
        • Recruiting
        • Hopital Nord CHU de SAint ETIENNE
        • Principal Investigator:
          • MAROTTE Hubert
      • Toulouse, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roactemra
subcutaneous tocilizumab
Drug: subcutaneous tocilizumab
162 mg subcutaneous, once a week during 12 months
Other Names:
  • Roactemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone erosion change after 12 months of subcutaneous tocilizumab
Time Frame: baseline and 12 months
changes of width measured by HRpQCT.
baseline and 12 months
Bone erosion change after 12 months of subcutaneous tocilizumab
Time Frame: baseline and 12 months
changes of depth measured by HRpQCT.
baseline and 12 months
Bone erosion change after 12 months of subcutaneous tocilizumab
Time Frame: baseline and 12 months
changes of volume measured by HRpQCT.
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associated factors with erosion changes assessed by HRqQCT
Time Frame: baseline, 3 months, 12 months
Number of participants with associated factors with erosion changes by HRpQCT (Associated therapeutic, clinical and biological response )ultrasound ...)
baseline, 3 months, 12 months
Effect of 12 months of tocilizumab on bone density in the PR
Time Frame: baseline, 12 months
Changes of Bone mineral density by DXA at the lumbar spine and proximal femur
baseline, 12 months
Effect of Tocilizumab on synovitis/tenosynovitis assessed by US and agreement with disease activity scores
Time Frame: Predictors baseline, 1 and 3 months of clinical remission and / or ultrasound at 6 and 12 months
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.
Predictors baseline, 1 and 3 months of clinical remission and / or ultrasound at 6 and 12 months
Effect of 12 months of tocilizumab on bone microarchitecture in the PR
Time Frame: baseline, 12 months
changes of bone microarchitecture by tibia HRpQCT
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Collaborators

Rennes University Hospital

Investigators

  • Study Director: SALLIOT Carine, MD, CHR Orléans
  • Principal Investigator: LESPESSAILLES Eric, MD, PhD, CHR Orléans
  • Principal Investigator: CANTAGREL Alain, MD, PhD, CHU Toulouse
  • Principal Investigator: CHAPURLAT Roland, MD, PhD, CHU Lyon
  • Principal Investigator: MAROTTE Hubert, MD, PhD, HOPITAL NORD SAINT ETIENNE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimated)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO 2014-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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