The ‘wear-and-tear’ effect and knee pain

Is knee osteoarthritis slowing you down? Do you find it difficult to walk long distances or climb stairs? Do you suffer from knee pain regularly?

If you answered yes to these questions, you’re not alone. Knee osteoarthritis is a common condition for millions of people1.

Daily walking, bending and standing can be hard on joints and may cause damage. Cartilage in your joints does not heal itself very well when it is damaged or injured. Once joint cartilage is damaged, it cannot repair itself as well as skin or bone can. This is why some people with osteoarthritis experience progressive worsening of their joints.

Current treatments available for knee osteoarthritis only focus on symptomatic relief. In some cases, knee replacement surgery is required. However, these options don’t target the root cause of osteoarthritis, so a different approach to treating the condition is needed. This program of clinical trials includes investigational drugs that will target cartilage regeneration and preservation, as well as pain and inflammation reduction.  
 

How might we be able to treat knee osteoarthritis?

Knee close up

Cartilage is a tough tissue found in many areas of the body. It has several functions.

Legs with bones

It covers the surface of joints, helping them move smoothly and without pain.

people with osteoarthritis

In people with osteoarthritis, this cartilage is damaged which can lead to pain and restricted movement.

Different investigational drugs will be researched during this program of clinical trials, targeting:

Regeneration and Preservation

Some participants will receive an investigational drug intended to help the body repair and re-grow healthy cartilage in the areas of your knee that have been damaged. The clinical trial team will investigate whether the cartilage in your knee is re-growing in response to the treatment. This will be measured using a magnetic resonance imaging (MRI) machine. Doctors and scientists will use an MRI machine to see the structure in your knee in precise detail.

Pain Reduction and Anti-Inflammation

Some participants will receive an investigational drug designed to work by reducing the inflammation, pain and cartilage degeneration associated with knee osteoarthritis.

 

What will taking part involve?

Participation in the clinical trial will last for a minimum of 19 weeks, and a maximum of 62 weeks. The length of your participation will depend on which trial you join. Each trial consists of three parts, as outlined below:

If you choose to take part, you will first be screened to confirm you are eligible for the trial.

If the trial is right for you, you will enter a treatment period. Depending on which clinical trial you join, you will be randomly assigned to receive either an investigational drug, an approved drug or a placebo. You will receive your assigned study treatment as an oral tablet or an injection.

After you have completed your study treatment, the clinical trial team will continue to monitor your health during clinic visits.

Who can take part?

Trial eligibility Yes checkbox in blue square icon

 

To take part in one of these clinical trials, in addition to other criteria, potential participants must:

  • Be between 35 and 80 years old
  • Have a diagnosis of tibiofemoral knee osteoarthritis
Trial Eligibility No cross mark in blue square icon

 

In addition to other criteria, potential participants must not:

  • Be pregnant or nursing (or planning to become pregnant or nurse during the trial)
  • Have a known autoimmune disease with associated joint inflammation, infection of the joint, Lyme disease involving the knee, systemic cartilage disorder or known systemic connective tissue disease
  • Be unable to undergo magnetic resonance imaging (MRI) scans

For full eligibility criteria of each trial, please visit: clinicaltrials.gov

Participation in clinical trials is completely voluntary.

See if you’re eligible

How will each participant’s health be monitored?

Participants will need to visit the study clinic regularly. This is so that we can administer their assigned trial treatment and monitor their general health and knee osteoarthritis with assessments such as:

Blood tests, blue syringe icon

Blood samples

Urine tests, blue test tube icon

Urine tests

Skin prick testing, blue microscope icon

Magnetic resonance imaging (MRI)

Vital signs, blue heart icon

Vital signs

Electrocardiograms (ECGs), blue heartbeat icon

Electrocardiograms (ECGs)

Stethoscope Icon

Knee OA assessment

Questionnaires, blue writing on sheet icon

Questionnaires

About Clinical Trials

Smiling female doctor reassuring a smiling male clinical trial participant by patting him on the shoulder in a supportive manner.

What is a clinical trial?

Every year, hundreds of thousands of people take part in clinical trials (also known as clinical studies). These are carefully controlled scientific investigations that help us improve medicine all around the world. They help us discover:

  • Alternative ways to diagnose conditions
  • Alternative ways to treat conditions
  • Alternative ways to track the progress of conditions

Clinical trials must be approved by regulatory boards before they can begin. Regulatory boards work to protect the safety and rights of clinical trial participants. They do this by reviewing and approving the trial’s protocol – a plan that explains the need for the trial, what participants will need to do and how their health will be monitored throughout.

Different types of clinical trials

Clinical trials help us answer scientific questions, but different types of trials help us do this in different ways, as described below.

Female doctor taking the blood pressure of a male clinical trial participant.

Interventional trials

Participants are asked to change their care somehow. For example, they may be asked to take an investigational drug or change their diet.

A female healthcare professional sits at a computer as she and two male healthcare professionals review the information on a screen.

Observational trials

Participants are asked to continue their usual healthcare regimen while healthcare professionals monitor their condition. For example, the level of a certain substance (e.g. an antibody) in the blood could be monitored.

Different phases of clinical trials

An investigational drug must pass through several stages of clinical trials before it can be submitted for approval for general use by the public. Each stage helps us answer different questions. Only once an investigational therapy has been shown to be safe in one phase may it progress to the next.

Investigators study the effects of an investigational drug in about 20 - 80 people. This phase is important for ensuring that an investigational drug is safe and helps us learn which doses may have a therapeutic effect.

These trials are conducted in a slightly larger group of about 100 - 300 people. The investigational drug may be compared with a placebo (a ‘dummy drug’) to help us learn whether it is an effective treatment and learn more about any potential side effects.

These usually involve up to 3,000 people to help us understand more about the safety and efficacy of an investigational drug, as well as how well it compares to existing treatments for a particular condition.

Medication approved for general use

These trials help us learn how the treatment affects people in the long-term. They only take place once a drug has been approved for general use.

Frequently asked questions

We’ve compiled answers to some of the most common questions about clinical trials, as well as any specific questions related to this particular program of clinical trials. If you have any other questions, please contact the trial team, who will be more than happy to assist you.

About clinical trials

A placebo looks just like an investigational drug and is given in the same way. However, it contains no active ingredients. Placebos are used to be sure that any treatment effects seen are due to an investigational drug and not some other factor, such as increased visits with the trial doctors. But that doesn’t mean people in the placebo group receive no care. The health of every participant will be closely monitored throughout their participation in a trial.

Participation in clinical trials is voluntary. This means that you are under no obligation to take part and you are free to leave at any time without penalty.

No. You do not need medical insurance to take part in clinical trials.

Every clinical trial must be approved by regulatory boards (such as the US Food and Drug Administration) before it can begin. It is the job of these boards to protect the safety and rights of a trial’s participants. They do this by reviewing the trial’s protocol. A protocol is a plan that explains the need for the trial, what participants will need to do, and how their health will be monitored.

Before a person can be enrolled into a clinical trial, they must meet eligibility criteria specific to that trial.

Trial-related medications and tests are provided at no cost and insurance is not required. The trial’s sponsor may pay for travel and accommodation-related expenses too.

This will depend on the trial. You will be provided with a detailed visit schedule before you enroll.

You may well have to take time off work to make appointments at the trial’s site. Before you enroll, you will be given a detailed visit schedule so you can consider this commitment before you decide to volunteer.

Many clinical trials are ‘randomized’ and ‘double-blind’. Randomized means a participant will be allocated to a treatment group by chance, like the flip of a coin. Double-blind means that neither the participant nor the trial team will know which group the participant is in until after the trial is complete. This is to ensure that any effects seen are due to the investigational drug alone. Some clinical trials offer ‘open-label’ treatment. This means participants and the trial doctor will know that they are receiving the investigational drug. If you pass the pre-screener, the study coordinator at the clinical trial site will be able to provide you with more information.

About our knee osteoarthritis program of clinical trials

We understand that walking and standing might be painful or uncomfortable for you because of the knee pain arthritis creates. Therefore, the site team will try to make your visits as comfortable as possible by providing physical assistance, enhanced mobility support and ensuring that clinic areas are accessible where possible. 

Benefits to taking part in one of these clinical trials include:

  • Access to knee osteoarthritis medical care
  • Access to an investigational drug which may improve your condition and quality of life
  • The opportunity to help researchers find out more about your condition and contribute to medical knowledge that may help other people in the future 

Depending on which trial you join, you will be randomly assigned to receive either an investigational drug, placebo, or an approved drug. Your study doctor will explain this in more detail, should you take part.

The trial you join may be ‘double-blind’. This means that neither you nor the trial team will know which group you’re in until after the trial is complete. This is to ensure that any effects seen are due to the investigational drug alone.

If the trial you join has an ‘open-label’ treatment, this means you and the trial doctor will know that you’re receiving the investigational drug. The trial doctor will explain what the chances are of receiving either the investigational drug, an approved drug or the placebo before you join the trial.

References:

  1. Arthritis Foundation: https://www.arthritis.org/diseases/osteoarthritis