Efficacy of Intra-Articular Triamcinolone Acetonide, Sodium Chloride, and Occupational Therapy in Carpometacarpal Osteoarthritis

The primary objective of the study is to evaluate the **efficacy** of intraarticular corticosteroid (IACS) injections compared to saline injections after 4 weeks, and to further compare the efficacy of IACS injections, saline injections, and a multimodal occupational therapy intervention after 12 weeks in patients with painful inflammatory **osteoarthritis** in the first carpometacarpal joint. This is clinically relevant as it aims to determine the most effective treatment modality for reducing pain and improving joint function in this specific type of osteoarthritis, which can significantly impact patients' quality of life.

Secondary objectives include assessing the effect of interventions on various clinical outcomes such as pain, physical function, stiffness, grip strength, disease activity, self-efficacy, patient satisfaction, and health-related quality of life. Additionally, the study aims to evaluate the impact of interventions on inflammation, bone marrow lesions, and structural progression. The occurrence of adverse events and the cost-effectiveness of the interventions are also being examined. These secondary objectives provide a comprehensive understanding of the interventions' broader impacts, which is crucial for informed clinical decision-making.

The clinical trial involves a study population comprising **men and women** aged between 40 and 85 years, diagnosed with **osteoarthritis** in the first carpometacarpal joint. The participants are required to have inflammation in the target joint confirmed by ultrasound and experience pain in the joint with a minimum score of 3 on a 0-10 Numeric Rating Scale at rest or during activities. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. The selection criteria ensure that participants are eligible for the proposed use of Kenacort-T. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **intraarticular corticosteroid** (IACS) injections compared to saline injections and a multimodal occupational therapy intervention in patients with painful inflammatory **osteoarthritis** in the first carpometacarpal joint. This study is a randomized, double-blind, controlled trial with an estimated duration from October 2023 to October 2027. Participants will be randomly assigned to receive either the IACS injection, saline injection, or occupational therapy intervention. The primary objective is to assess the superiority of IACS injections over saline injections after 4 weeks and to compare the efficacy of all three interventions after 12 weeks.

The trial will include several study visits, beginning with a screening visit to confirm eligibility based on criteria such as age (40-85 years), confirmed osteoarthritis in the target joint, and a minimum pain score. Following randomization, participants will attend follow-up visits at weeks 4, 12, 24, and 104, with assessments including changes in joint pain, function, and overall disease activity. The end-of-study visit will occur at week 104, marking the conclusion of participant involvement. The expected length of participant involvement is approximately two years, with conditions for early termination including adverse events or withdrawal of consent.

Primary endpoints include changes in thumb base joint pain during activities over the last 24 hours on a Numeric Rating Scale (NRS) at weeks 4 and 12. Secondary endpoints encompass a range of measures such as changes in finger joint pain, grip strength, and use of analgesics, assessed at multiple time points throughout the study. The trial will also monitor adverse events and serious adverse events to ensure participant safety. Participants may be withdrawn from the study if they experience significant adverse events or if they choose to discontinue participation for any reason.

The clinical trial involves the administration of two primary treatments for patients with painful inflammatory osteoarthritis in the first carpometacarpal joint. The first treatment is **Natriumklorid Fresenius Kabi 9 mg/ml**, a solvent for parenteral use, containing the active substance **sodium chloride**. This solution is administered via intra-articular injection. The maximum daily dose is 0.5 ml, with a total maximum dose of 4 ml over the treatment period. The administration is conducted under controlled conditions to ensure precise dosing and participant compliance is monitored throughout the trial.

The second treatment is **Kenacort-T 40 mg/ml**, an injection suspension containing the active substance **triamcinolone acetonide**. This corticosteroid is also administered via intra-articular injection. The maximum daily dose is 20 mg, with a total maximum dose of 160 mg over the treatment period. As with the sodium chloride solution, the administration of Kenacort-T is carefully monitored to ensure adherence to the dosing schedule and to assess participant compliance. Both treatments are provided in a non-paediatric formulation and are not classified as orphan drugs. The trial aims to compare the efficacy of these treatments, alongside a multimodal occupational therapy intervention, over a 12-week period.

Efficacy in the clinical trial titled "Painful Inflammatory Carpometacarpal-1 Osteoarthritis treated with intraarticular Steroids, Saline or an Occupational therapy intervention: the PICASSO trial" will be assessed using both primary and secondary endpoints. The primary endpoints focus on the change in thumb base joint pain during activities over the last 24 hours, measured on a Numeric Rating Scale (NRS) after 4 weeks and 12 weeks. Secondary endpoints include a variety of measures such as changes in finger joint pain, the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain, stiffness, and function subscales, and the number of OMERACT-OARSI criteria responders. Additional assessments will be conducted using the Measure of Activity Performance of the Hand (MAP-Hand), patient-reported and assessor-reported overall disease activity, grip strength, and the use of analgesics and NSAIDs. Other secondary endpoints involve changes in arthritis self-efficacy, patient satisfaction, EuroQol 5 dimensions 5-levels (EQ-5D-5L), and the number of tender and swollen hand joints. Imaging techniques such as ultrasound and MRI will be used to evaluate synovitis and bone marrow lesions in the CMC-1 joint. Structural progression will be assessed by the Kellgren-Lawrence scale, and changes in osteophytes and joint space narrowing will be evaluated using the OARSI atlas. The trial will also monitor the number of adverse events, serious adverse events, and withdrawals due to adverse events. Efficacy parameters will be collected and analyzed at multiple timepoints, including weeks 0, 4, 12, 24, and 104, with some assessments occurring at the time of injection (INJ). The trial aims to determine the superiority of intraarticular corticosteroid injections over saline injections after 4 weeks and to compare the efficacy of these treatments with a multimodal occupational therapy intervention after 12 weeks in patients with painful inflammatory **osteoarthritis** in the first carpometacarpal joint.