NCT02765074CompletedPhase 4
Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis
Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study
Source: ClinicalTrials.gov · Last updated 20 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 19 Apr 2016
- Start date
- 30 Jun 2016
- Primary completion date
- 3 Apr 2025
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT02765074
- EU CT number
- 2024-517686-17-01
- EudraCT number
- 2015-004801-18
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 30 Jun 2016 to the primary completion date, 3 Apr 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments.
Lab values
- 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:
Other
- Absence of informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 03 | France | Active, not recruiting |
| Centre Hospitalier Universitaire D Orleans Coordinator of this site? Confirm its status | Orleans Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.