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Study on Colchicine for Patients with Knee or Hip Osteoarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Colchicine on individuals with osteoarthritis of the knee or hip. Osteoarthritis is a common joint condition that causes pain and stiffness, often leading to the need for joint replacement surgery. The study will compare the effects of taking Colchicine tablets, which are taken orally, to a placebo. The purpose of the study is to see if Colchicine can reduce the need for knee or hip replacement surgery in people with this condition.

Participants in the study will be randomly assigned to receive either Colchicine or a placebo. The study will last for a period of time, during which participants will take the medication daily. Throughout the study, researchers will monitor the participants to see if there is a difference in the number of knee or hip replacements needed between those taking Colchicine and those taking the placebo. Additionally, the study will observe changes in pain levels, physical function, and quality of life over the course of the trial.

The study will also look at other factors, such as the progression of osteoarthritis in other joints, the use of pain medication, and any new cardiovascular events that may occur. By the end of the study, researchers hope to gather valuable information on whether Colchicine can be an effective treatment option for reducing the need for joint replacement surgery in people with knee or hip osteoarthritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age between 45 and 80, a clinical diagnosis of knee or hip osteoarthritis, and documented radiographic changes typical for advanced osteoarthritis.
Step 2
Randomization
Participants are randomly assigned to receive either Colchicine Tiofarma 500 microgram Tablets or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
Step 3
Medication administration
The assigned medication, either colchicine or placebo, is taken orally once daily. The dosage for colchicine is 0.5 mg per day.
Step 4
Monitoring and assessments
Throughout the trial, various assessments are conducted to monitor the course of pain, physical function, and quality of life. Radiological progression and changes in low-grade inflammation are also evaluated at one year and at the end of the study.
The onset of new joint issues or cardiovascular events is tracked, along with the use of pain medication and related costs.
Step 5
Completion of the trial
The trial is expected to conclude by April 30, 2029. The primary endpoint is the time from randomization to the first incident of knee or hip replacement. Secondary endpoints include various health and quality of life measures over the trial period.

Who can join the trial?

6 criteria

You must have a clinical diagnosis of knee or hip osteoarthritis (OA). This means a doctor has confirmed you have this condition.
Your age must be between 45 and 80 years old.
You need to have documented radiographic changes typical for advanced knee or hip OA. This means X-ray or similar imaging shows changes in your joints that are common in advanced OA. The changes should have a Kellgren & Lawrence score of 2 or higher, which is a way to measure the severity of OA.
If you don't have the radiographic changes, you should have at least a 2-year history of complaints due to OA in the hip and/or knee. This means you have been experiencing symptoms related to OA for at least two years.
Both men and women can participate in the study.
The study is not for vulnerable populations, which means it is not designed for groups who might need special protection or care.

Who cannot join the trial?

7 criteria

Patients who have a known allergy or sensitivity to colchicine or any of its ingredients cannot participate. Colchicine is a medication used to treat certain conditions.
Individuals who are currently taking medications that interact negatively with colchicine are excluded. This means if the medicine you are taking could cause harmful effects when combined with colchicine, you cannot join the study.
Patients with severe liver or kidney disease are not eligible. The liver and kidneys are important organs that help process and remove substances from the body.
Women who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Individuals who have participated in another clinical trial within the last 30 days are excluded. This is to avoid any interference from other treatments or medications.
Patients with a history of alcohol or drug abuse are not eligible. This is because such conditions can affect the study results and the patient's health.
Anyone with a serious medical condition that could interfere with the study or pose a risk to the patient is excluded. This includes conditions that might make it unsafe for the patient to participate.

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Verified sites

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Reade revalidatie & reumatologie centrum te Amsterdam
Amsterdam, The Netherlands
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Rijnstate Ziekenhuis Stichting
Arnhem, The Netherlands

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Investigated drugs

Colchicine is a medication used in this trial to see if it can reduce the need for knee or hip replacements in patients with osteoarthritis. It is taken once daily and is being compared to a placebo to determine its effectiveness in managing symptoms and delaying surgery.

Colchicine

What is already known about the treatment

Colchicine – Colchicine is administered orally in the form of tablets, typically at a dose of 0.5 mg once daily. It is currently being studied in clinical trials for its potential to reduce the need for knee or hip replacements in patients with osteoarthritis. The main therapeutic indication for colchicine in this context is to manage symptoms and potentially delay surgical interventions in osteoarthritis of the knee or hip. At the molecular level, colchicine works by disrupting microtubule formation, which can reduce inflammation and alter immune responses. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Osteoarthritis – Osteoarthritis is a common joint disorder that primarily affects the cartilage, which is the protective tissue at the ends of bones. As the cartilage wears down over time, it can lead to pain, swelling, and reduced motion in the affected joints. The condition often progresses slowly, with symptoms worsening over the years. It most commonly affects joints in the hands, knees, hips, and spine. As the disease advances, bone spurs may develop, and the joint may become stiff and painful. Osteoarthritis can significantly impact daily activities and quality of life due to joint discomfort and limited mobility.