Extract

Background and study aims Osteoarthritis (OA) is the most prevalent form of arthritis and is an increasingly common problem in our aging society. In the UK an estimated 8.5 million people are affected by OA, causing an enormous burden to health authorities, as well as considerable pain and disability to these individuals. A recent study by Arthritis Care reported that 81% of people with OA experience constant pain and 72% have important related conditions, such as high blood pressure or depression. Hand OA is generally considered to be less important and less disabling than knee or hip OA, but 8% of the UK population are estimated to be effected by painful hand OA, with a large proportion reporting significant difficulties with common day-to-day tasks, leading to reduced capacity to work and impacting on both quality of life and general health. However, despite the prevalence of hand OA, there are still limited treatment options. Current treatments for hand OA are limited since they have been shown to only work for short periods and are not effective for all patients. In addition, many of these treatments have side effects that restrict their use. Hydroxychloroquine is commonly used to treat inflammatory arthritis, such as rheumatoid arthritis, to great effect. It has very few side effects. Recent studies suggest that inflammation is also important in OA, and that by reducing inflammation pain will also be reduced. We believe that hydroxychloroquine may be an effective treatment for reducing inflammation in hand OA and that this reduction in inflammation will lead to a reduction in pain. The primary aim of this study is to determine whether hydroxychloroquine is effective at relieving pain in people with painful hand OA. The secondary aim of the study is to determine whether hydroxychloroquine is able to slow or stop the damage to joints caused by OA. The third aim of the study is to determine whether people with more arthritis-related inflammation in their hand (detected by ultrasound imaging) respond better to treatment with hydroxychloroquine. Who can participate? People with hand OA from across England. Participants must have moderate to severe painful hand OA that is not responding to their current treatment. In addition, they must have evidence of damage to their joints that is typical of OA – which is detected using an X-ray. There are no age restrictions. What does the study involve? Participants will be randomly allocated to one of two groups – the first group will take hydroxychloroquine tablets for 12 months and the second group will take a placebo (dummy) tablet for 12 months. Participants and the researchers running the study will not know which group they are allocated to. Both groups will be allowed to continue taking any other medication for their hand OA that they are using at the start of the study. During the 12 months of the study participants will be asked to attend a special clinic three times for about 1 hour (in addition to a screening visit during which eligibility is assessed) and will be asked to fill in a number of questionnaires and complete a number of hand function tests. At the end of the study we will analyse the change in pain scores between the two groups to determine whether hydroxychloroquine is effective at reducing the painful symptoms of hand osteoarthritis. We will also assess whether hydroxychloroquine improves hand function and slows down the structural damage to the hand joints which is associated with OA. What are the possible benefits and risks of participating? You may not benefit directly from this study. However, the trial will give us useful information which may be of benefit to others in the future and aid the development of treatment for OA. The main risk involved in taking part is potential side-effects associated with hydroxychloroquine. Hydroxychloroquine has been used for many years and is relatively safe, with side effects being unlikely. In a small minority of people it can be associated with skin rashes, indigestion, diarrhoea, headaches or blurred vision. Very rarely hydroxychloroquine may damage the retina (part of the eye), but it is important to note that damage to the eye is associated with a cumulative dose of more than 500 g, equivalent to taking the trial medication for 3.4 years. In the duration of this study, the total hydroxychloroquine dose will remain well below this level. To minimise any risk of visual complications participants will be asked about visual impairment (not corrected by glasses) and their eyesight (with glasses where appropriate) will be recorded using a standard reading chart. It is standard practice for all patients taking hydroxychloroquine to have regular blood tests. These are to check that there are no changes to your liver or kidney function during the study. This is not because taking hydroxychloroquine will damage your liver or kidney, but because if you develop liver or kidney problems during the study for another reason, we would need to stop your study medication. We will therefore ask participants to have a blood test before the study, and at 6 and 12 months. There is also a very small risk associated with having hand x-rays for the study. Having an X-ray of each hand will expose you to a small amount of radiation (roughly comparable to the amount of background radiation received in the UK every month). Participants will have an X-ray of each hand at the start and end of the study. The lifetime risk of inducing a fatal cancer in a healthy individual with this dose of radiation is low, about 1 in 500,000. Where is the study run from? University of Leeds, Leeds Institute of Rheumatic Musculoskeletal Medicine, Chapel Allerton Hospital (UK) When is the study starting and how long is it expected to run for? The study is expected to start in September 2012 and will run for about two and a half years. The trial will recruit participants for about a year and a half. Who is funding the study? Arthritis Research UK Who is the main contact? Dr Sarah Kingsbury [email protected]

Inclusion criteria

• Hand Osteoarthritis

Links

• isrctn
• ictrp