Tocilizumab for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010 classification criteria\n- DAS 28 greater than 3.2 despite DMARD or biological treatment (other than tocilizumab)\n- Superior or equal to one joint erosion at the right or left MCP 2, 3 on X-rays\n- Oral corticosteroid ≤ 10 mg/day prednisone or equivalent stable for at least one month\n- Rhumatoid Arthritis patients eligible to subcutaneous Tocilizumab monotherapy in combination with a DMARD or as monotherapy (according to MA)\n- Men and women at least 18 years old"}

Exclusion criteria

• {"criterion_text":"- Treatment with zoledronic acid or denosumab (less than one year)\n- Intra-articular injection of corticosteroids at the MCP in the previous three months\n- Patients with confluent erosions on ultrasonography\n- 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,\n- Absence of informed consent\n- Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments"}

Primary endpoints

• {"endpoint_text":"- Bone erosion change of width, depth and volume measured by HRpQCT after 12 months of subcutaneous tocilizumab","definition_or_measurement_approach":"Measured by HRpQCT at 12 months; translations specify variations of diameter, depth and volume of erosions at the radial side of the 2nd and 3rd metacarpal heads, for erosions of diameter >1.9 mm and depth >1.45 mm, measured by HRpQCT after 12 months of treatment."}

Secondary endpoints

• {"endpoint_text":"- Number of participants with associated factors with erosion changes by HRpQCT (Associated therapeutic, clinical and biological response )ultrasound ...)","definition_or_measurement_approach":"Assessment of associated therapeutic, clinical and biological responses and ultrasound factors in participants with erosion changes measured by HRpQCT."}
• {"endpoint_text":"- Changes of Bone mineral density by DXA at the lumbar spine and proximal femur","definition_or_measurement_approach":"Bone mineral density changes measured by DXA at lumbar spine and proximal femur."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Correlation analyses between clinical activity indices (e.g., DAS28, Clinical Disease Activity Index, Simplified Disease Activity Index, ACR-EULAR) and ultrasound data."}
• {"endpoint_text":"- Changes of bone microarchitecture by tibia HRpQCT","definition_or_measurement_approach":"Assessment of bone microarchitecture changes using HRpQCT of the tibia."}

France

Earliest CTIS Part Ii Submission Date

20-12-2024

Latest Decision Or Authorization Date

02-01-2025

Processing Time Days

13

Number Of Sites

4

Number Of Participants

60

Primary sponsor

Full Name

Centre Hospitalier Universitaire D Orleans

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France