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NCT Number: NCT02765074

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Edouard HERIOT, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

subcutaneous tocilizumab

Drug

162 mg subcutaneous, once a week during 12 months

Other names: Roactemra

Primary outcomes

  1. Bone erosion change after 12 months of subcutaneous tocilizumab

    Time frame: baseline and 12 months

    changes of width measured by HRpQCT.

  2. Bone erosion change after 12 months of subcutaneous tocilizumab

    Time frame: baseline and 12 months

    changes of depth measured by HRpQCT.

  3. Bone erosion change after 12 months of subcutaneous tocilizumab

    Time frame: baseline and 12 months

    changes of volume measured by HRpQCT.

Secondary outcomes

  1. 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 ...)

  2. 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

  3. 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.

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

    Time frame: baseline, 12 months

    changes of bone microarchitecture by tibia HRpQCT

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Collaborators

  • Rennes University Hospital

Registry information

Official study title

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

Acronym: REPAIR

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
May 6, 2016
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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