Triamcinolone acetonide for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Newly diagnosed rheumatoid arthritis patients according to a rheumatologist\n- DMARD-naive\n- Age 18 – 64 years old\n- DAS28-CRP > 2.6 at the start of the study\n- Dutch proficiency\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Current or prior treatment with DMARDs\n- Risk of cardiovascular diseases\n- Risk of malignancies, including current smoking of having smoked for a long time\n- (Planned) pregnancy or planning to father a child\n- Contra-indications for methotrexate, adalimumab, tocilizumab, hydroxychloroquine, triamcinolone, filgotinib or folic acid (protocol section 4.3)\n- Corticosteroid use in the last three months"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this study is the percentage of rheumatoid arthritis patients in remission (DAS28-CRP < 2,6) at three months.","definition_or_measurement_approach":"Remission defined as DAS28-CRP < 2.6; measured as the percentage of participants meeting this criterion at 3 months."}

Secondary endpoints

• {"endpoint_text":"- Disease activity remission at 6, 9 and 12 months","definition_or_measurement_approach":"Remission assessed at 6, 9 and 12 months (presumably using DAS28-CRP)."}
• {"endpoint_text":"- Disease activity scores and components at 3, 6, 9, and 12 months","definition_or_measurement_approach":"Disease activity scores and their components measured at 3, 6, 9 and 12 months (e.g., DAS28 components)."}
• {"endpoint_text":"- Changes in biomarkers: CRP and ESR","definition_or_measurement_approach":"Measurement of CRP and ESR levels over time (during 12 months of treatment)."}
• {"endpoint_text":"- Time to diseases activity remission and remission duration","definition_or_measurement_approach":"Time-to-event analysis for time to remission and measurement of duration of remission."}
• {"endpoint_text":"- Patient-reported outcome measures","definition_or_measurement_approach":"Collection of patient-reported outcomes over study visits (3 months and up to 12 months)."}
• {"endpoint_text":"- Adherence to treatment","definition_or_measurement_approach":"Assessment of treatment adherence in both treatment arms (method not specified)."}
• {"endpoint_text":"- Patient satisfaction","definition_or_measurement_approach":"Assessment of patient satisfaction with treatment strategies (method not specified)."}
• {"endpoint_text":"- Adverse events: incidence and severity (side effects)","definition_or_measurement_approach":"Recording incidence and severity of adverse events during the study period."}
• {"endpoint_text":"- Direct and indirect costs","definition_or_measurement_approach":"Health economics assessment of direct and indirect costs (method not specified)."}
• {"endpoint_text":"- The cumulative dosage of corticosteroids over the study period","definition_or_measurement_approach":"Calculation of cumulative corticosteroid dose per participant over the study period."}
• {"endpoint_text":"- The cumulative usage of bDMARDs over the study period","definition_or_measurement_approach":"Calculation of cumulative usage of biological DMARDs during the study period."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-01-2025

Latest Decision Or Authorization Date

16-01-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

168

Primary sponsor

Full Name

Medisch Spectrum Twente

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands