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

Last updated: June 26, 2024
Sponsor: Centre Hospitalier Régional d'Orléans
Overall Status: Active - Recruiting

Phase

4

Condition

Joint Injuries

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Treatment

subcutaneous tocilizumab

Clinical Study ID

NCT02765074
CHRO 2014-03
  • Ages 18-85
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010classification criteria

  • DAS 28 superior or equal to 3.2 despite DMARD or biological treatment (other thantocilizumab)

  • 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 onemonth

  • RA patients eligible to subcutaneous Tocilizumab monotherapy

Exclusion

Exclusion Criteria:

  • Treatment with zoledronic acid or denosumab (less than one year)

  • Intra-articular injection of corticosteroids at the MCP in the previous threemonths

  • Tocilizumab contra-indications in accordance with SPC (Summary of ProductCharacteristics) :Hypersensitivity to the active substance or to any of theexcipients Active, severe infections including active tuberculosisDiverticulitis Active hepatic disease and hepatic Impairment including viralhepatitis 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 ofimaging assessments.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: subcutaneous tocilizumab
Phase: 4
Study Start date:
June 30, 2016
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Hopital Edouard HERIOT

    Lyon, 69437
    France

    Active - Recruiting

  • CHR d'ORLEANS

    Orleans, 45067
    France

    Active - Recruiting

  • Hopital Nord CHU de SAint ETIENNE

    Saint Etienne,
    France

    Active - Recruiting

  • Chu Toulouse

    Toulouse,
    France

    Active - Recruiting

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