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Illustration only. No efficacy or safety is implied.

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

Do you suffer with pain every day? Do you find it difficult to walk long distances or climb stairs? Does cold weather and rain make your pain worse?

If you answered yes to these questions, you’re not alone. Knee osteoarthritis is a common condition for millions of people1. But what makes our knees so vulnerable to this disease?

Daily walking, bending and standing is hard on our joints and can cause damage. Most of the time, our body repairs this damage before it affects the cartilage. But once the cartilage is damaged, it cannot repair itself. This is why people with osteoarthritis experience progressive worsening of their joints.

Damaged cartilage results from the ‘wear-and-tear’ effect and causes the pain and stiffness that many experience with osteoarthritis.

ONWARDS is a clinical trial researching an investigational drug which could help people with osteoarthritis of the knee.

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Can we regenerate cartilage?

Cartilage image 1

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

Cartilage image 2

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

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

Cartilage image 4

When cartilage is damaged, the number of stem cells within it increases.

The investigational drug is designed to work by targeting these stem cells. This trial is researching if these stem cells will then develop into different cells that will help repair and regenerate the damaged cartilage. 

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What will this trial involve?

ONWARDS is a phase 2 interventional clinical trial that will last for approximately 5 years and will include visits to the study clinic and telephone visits, as outlined below:

Screening period

2 visits over a period of approximately 2 months

We’ll carry out some tests to see if potential participants are eligible for the study. 

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Treatment period

Approximately one visit a month over 2 years

Participants will be randomly assigned to receive either:

20mg of the investigational drug
OR
40mg of the investigational drug
OR
A placebo (1 in 5 chance)

One cycle consisting of 3 intra-articular injections into the knee will be administered into the affected knee each every 6 months over a period of 2 years.

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Extension period

Approximately 4 in-office visits and 6 telephone visits

Participants will continue to receive the same study drug they received in the treatment period.

One intra-articular injection will be administered into the affected knee every 6 months over 2 years.

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Follow-up period

Approximately 5 visits over 1 year (2 in-office and 3 telephone visits)

We’ll continue to monitor participants’ health and condition.

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Who can take part?

If you have knee osteoarthritis, consider joining this new clinical trial.

To take part in the trial, in addition to other criteria, potential participants must:

  • Be between 40 and 75 years old
  • Have a body mass index (BMI) under 40 at the time of screening
  • Have a diagnosis of tibiofemoral osteoarthritis in one knee

People who fulfill any of the following, in addition to other criteria, will not be eligible for this trial:

  • Women who are (or are likely to become) pregnant or nursing
  • Patients with a known autoimmune disease, infection of the joint, Lyme disease involving the knee, systemic cartilage disorder or known systemic connective tissue disease
  • Patients unable to undergo magnetic resonance imaging (MRI) scans

For the full inclusion and exclusion criteria, please visit: clinicaltrials.gov

Participation in this clinical trial is completely voluntary.

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How will each participant’s health be monitored?

During this trial, participants will attend about 42 study visits over the course of 5years. Half of these will be at the study clinic and the other half will be over the phone. For some participants, the number of visits might be higher.

Various health checks will take place during visits, like:

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Physical examinations*

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MRI (Magnetic Resonance Imaging) scans

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Electrocardiogram (ECG)

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Questionnaires

Walking assessments

Walking assessments (optional, at selected sites)

Activity assessments

Activity assessments

e-Diaries

e-Diaries

*For example, examination of general appearance, skin, neck, eyes, ears, nose, throat, lungs, heart and abdomen.

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How is the investigational treatment given?  

The study drugs (both the investigational drug and placebo) are injected intra-articularly (directly into the joint) in the affected knee. The trial team will do everything they can to make participants feel comfortable during their treatment.

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About Clinical Trials

What is a clinical trial?

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

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Alternative ways to diagnose conditions

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Alternative ways to treat conditions

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Alternative ways to track the progress of conditions

Clinical trials must be approved by institutional review boards before they can begin. These boards work to protect the safety and rights of trial participants. They do this by reviewing and approving the trial’s protocol – a plan that explains the need for the trials, 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. For example: 

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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. 

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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 drug has been shown to be safe in one phase may it progress to the next.

Phase 1

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.

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Phase 2

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 recorded side effects.

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Phase 3

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.

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Medication approved for general use

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Phase 4

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.

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Frequently Asked Questions

We’ve compiled answers to some of the most common questions about clinical trials. If you have specific questions about a clinical trial you are considering, please contact the trial’s study team, who will be more than happy to assist you. 

I can’t walk very far or it’s painful for me to walk. What support will I receive during trial visits?

We understand that walking and standing might be painful or uncomfortable for you because of the knee pain this 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.

What health measures have you put in place with regards to COVID-19?

The safety of all participants, the trial team and their families is our main priority. Therefore, we have put in place a number of strict safety precautions to minimize the risk of COVID-19 spreading between individuals involved in this clinical trial. All participants will be asked to comply with these measures which include:

  • Socially distanced clinic visits (i.e. staggered appointments, reduced contact in waiting rooms and communal areas) 
  • Enhanced cleaning of clinics
  • The provision of full PPE where appropriate
  • Hand sanitization points

What is a placebo and why is it used? 

A placebo looks just like the 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 the 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 the trial. 

What are the benefits of taking part?

Benefits to taking part in 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

What will happen if I change my mind part-way through the trial and decide to leave?

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. However, we would encourage all potential participants to stay in a trial for its duration, if possible.

Do I need medical insurance to take part?

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

Are clinical trials safe?

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.

Will I have to pay for anything?

There is no cost to participate in the trial, and insurance is also not required. Study clinic visits, the investigational drug, and all study-related tests and examinations are provided at no cost.

Will I need to take time off work to take part in the study?

You may 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.

Why won’t I know which group I’ll be in?

Many clinical trials are ‘randomized’ and ‘double blind’. Randomized means you will be allocated to a treatment group by chance, like the flip of a coin. Double-blind means that neither the participant nor the study 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

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References: 
1. World Health Organization (WHO) website: https://www.who.int/chp/topics/rheumatic/en/
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