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Filling bone erosions: a longitudinal multicentric HR-pQCT study of subcutaneous tocilizumab in rheumatoid arthritis
EU CTIS ID: 2024-517686-17-01
What this study is testing
Evaluate the variation in the diameter, depth and volume of erosions measured by HRpQCT in patients with rheumatoid arthritis treated with tocilizumab for 12 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010 classification criteria
- DAS 28 greater than 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
- Rhumatoid Arthritis patients eligible to subcutaneous Tocilizumab monotherapy in combination with a DMARD or as monotherapy (according to MA)
- Men and women at least 18 years old
You likely can't join if
- Treatment with zoledronic acid or denosumab (less than one year)
- Intra-articular injection of corticosteroids at the MCP in the previous three months
- Patients with confluent erosions on ultrasonography
- 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,
- Absence of informed consent
- Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.