A Phase 4 interventional study of subcutaneous tocilizumab in Rheumatoid Arthritis, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 4 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Centre Hospitalier Régional d'Orléans · Phase 4, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with zoledronic acid or denosumab (less than one year)
General:
subcutaneous tocilizumab
Drug: subcutaneous tocilizumab
162 mg subcutaneous, once a week during 12 months
Also known as: Roactemra
Bone erosion change after 12 months of subcutaneous tocilizumab
changes of width measured by HRpQCT.
Time frame: baseline and 12 months
Bone erosion change after 12 months of subcutaneous tocilizumab
changes of depth measured by HRpQCT.
Time frame: baseline and 12 months
Bone erosion change after 12 months of subcutaneous tocilizumab
changes of volume measured by HRpQCT.
Time frame: baseline and 12 months
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 ...)
Time frame: baseline, 3 months, 12 months
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
Time frame: baseline, 12 months
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.
Time frame: 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
changes of bone microarchitecture by tibia HRpQCT
Time frame: baseline, 12 months
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Régional d'Orléans