Randomized, Double-Blind, Multicenter Trial Comparing Prednisolone and Colchicine for Acute Gout Attack Management in Primary Care

The primary objective of this clinical trial is to evaluate the **most severe pain** experienced in the last 24 hours, as measured by an 11-point numerical rating scale, on day 3 after baseline in patients experiencing an acute gout attack. This is clinically relevant as it directly assesses the efficacy of the treatment in alleviating the acute pain associated with gout, which is a critical aspect of patient care and management.

Secondary objectives include:

• The average response to treatment from day 1 to 6 of follow-up.
• Assessment of swelling and tenderness of the joint, measured with a 4-point Likert scale, on day 3 after baseline.
• Evaluation of physical function on day 6 compared to baseline.
• Overall assessment of treatment success by patients, measured with a 5-point Likert scale, on day 6 after baseline.
• Frequency of taking additional pain medication per treatment group.
• Frequency of use of non-drug pain therapies in the treatment groups.

The clinical trial focuses on adult patients experiencing an **acute gout attack**, specifically targeting those with acute pain in the hand or foot, known as podagra or chiragra. The study population includes both male and female participants aged 18 years and over. Participants were selected based on the onset of pain being no more than two calendar days prior to enrollment and a clinical diagnosis of an acute gout attack. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants' willingness to participate and ability to provide written informed consent were also considered. No specific lifestyle considerations such as diet or physical activity were highlighted in the selection process.

The clinical trial is a **randomized**, **double-blind**, controlled study designed to evaluate the efficacy of **prednisolone** versus **colchicine** in the treatment of acute gout attacks. The trial is conducted in a multicentric setting and aims to assess the most severe pain experienced by participants in the last 24 hours, measured on an 11-point numerical rating scale, on day 3 after baseline. The study involves adult patients aged 18 years and over, who have experienced acute pain in the hand or foot, with the onset of pain occurring no more than two calendar days prior to enrollment. Participants must have a clinical diagnosis of an acute gout attack and be willing to provide written informed consent.

The trial is expected to run until January 31, 2026, with recruitment having started on January 18, 2023. Participants will be involved in the study for a maximum treatment period of 5 days. The trial includes several study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the inclusion criteria. Follow-up visits will occur from day 1 to day 6 to monitor the average response to treatment, swelling and tenderness of the joint, physical function compared to baseline, and the overall assessment of treatment success by patients. The end-of-study visit will evaluate the primary and secondary endpoints, including the frequency of additional pain medication use and non-drug pain therapies.

Participants will be randomly assigned to receive either prednisolone, colchicine, or a placebo. The maximum daily dose for prednisolone is 30 mg, with a total dose not exceeding 150 mg over the treatment period. For colchicine, the maximum daily dose is 1.5 mg, with a total dose not exceeding 5.5 mg. Placebo groups will receive a maximum daily dose of 3 mg for placebo colchicine and 1 mg for placebo prednisolone. The trial is designed to ensure that neither the participants nor the investigators know which treatment the participants are receiving, maintaining the double-blind nature of the study.

Participant involvement may be terminated early if they experience adverse effects, withdraw consent, or if the investigator deems it necessary for the participant's safety. The trial's primary endpoint is the assessment of the most severe pain in the last 24 hours, while secondary endpoints include the average response to treatment, joint swelling and tenderness, physical function, and the overall success of the treatment as assessed by the participants. The study aims to provide valuable insights into the comparative effectiveness of prednisolone and colchicine in managing acute gout attacks.

The clinical trial involves the administration of **PREDNISOLONE**, a glucocorticosteroid, in the form of tablets. The active substance, prednisolone, is of chemical origin. The maximum daily dose is 30 mg, with a total maximum dose of 150 mg over a treatment period of 5 days. The medication is administered orally, and participant compliance is monitored to ensure adherence to the dosing schedule.

**COLCHICINE** is used as a comparator treatment in this study. It is also administered in tablet form, with the active substance being colchicine, derived from a chemical origin. The maximum daily dose is 1.5 mg, and the total maximum dose is 5.5 mg over a 5-day treatment period. The route of administration is oral, and compliance is monitored to maintain the integrity of the trial.

The study includes a **Placebo** group for both prednisolone and colchicine. The placebo for colchicine, referred to as Placebo Colchicin, and the placebo for prednisolone, referred to as Placebo Prednisolon, are administered orally. The maximum daily dose for Placebo Colchicin is 3 mg, with a total maximum dose of 11 mg over 5 days. For Placebo Prednisolon, the maximum daily dose is 1 mg, with a total maximum dose of 5 mg over the same period. These placebos are used to maintain the double-blind nature of the trial, ensuring unbiased results.

Efficacy in the clinical trial titled "Pragmatic, randomized, multicentric, double-blind, controlled clinical trial on the treatment of acute gout attacks with prednisolone versus colchicine in primary care (COPAGO)" will be assessed using both primary and secondary endpoints. The primary endpoint is the evaluation of the **most severe pain** experienced in the last 24 hours, measured on an 11-point numerical rating scale, specifically on day 3 after baseline. Secondary endpoints include the average response to treatment from day 1 to day 6 of follow-up, swelling and tenderness of the joint, physical function on day 6 compared to baseline, overall assessment of the success of treatment by patients, the most severe pain in the last 24 hours, frequency of use of additional pain medication per treatment group, and frequency of use of non-drug pain therapies in the treatment groups.