Patient story: Brenda from Chatham is taking part in rheumatoid arthritis research
Brenda Balcombe, 64 from Chatham in Kent has taken part in rheumatoid arthritis research at Maidstone Hospital.
Rheumatoid arthritis is an autoimmune disease where the immune system attacks the cells that line joints by mistake, making joints of hands, feet, and wrists swollen, stiff and painful. Over time, this can damage the joints, cartilage and nearby bone.
There's no cure for rheumatoid arthritis. Methotrexate is usually the first medicine given often with another disease-modifying anti-rheumatic drug and a short course of steroids to relieve any pain.
Brenda shares her experience of being in a clinical trial
Brenda says: “In 2015 I was diagnosed with rheumatoid arthritis. It should be called rheumatoid disease, as my consultant calls it because the immune system thinks there is something wrong with you and attacks the cells in your joints and they become inflamed.
“Before I had any treatment I would wake up and my hands would not work properly, I would have to stretch them and then it would take an hour before I felt up and running. After doing some tests with doctors, I was referred to the rheumatology department at Maidstone Hospital and saw Dr. Batley who diagnosed me with the condition.
“I was given an intensive course of steroids then I started the methotrexate treatment. The treatment worked and I started to feel better. Eventually, I came off the steroids and only took the methotrexate. It worked for three years until unfortunately last year I caught pneumonia and the methotrexate stopped working.
“Dr. Batley knew the methotrexate had stopped working and because it had, he asked me if I would join a trial run at the hospital. Dr. Batley gave me the paperwork and two nurses came to explain everything to me. I was under no pressure to agree to take part and I was able to go away, read the information, talk to family and friends and then decide whether or not to sign up. I decided to say yes to the trial after doing my homework, I had nothing to lose but everything to gain.”
The trial Brenda took part in was CREDO-2. The purpose of CREDO-2 was to determine how effective the study drug Olokizumab is in patients with rheumatoid arthritis who are already receiving but not fully responding to treatment with methotrexate.
Patients were randomised to one of four treatment groups. Patients either took Olokizumab 64mg every four weeks, Olokizumab 64mg every two weeks, Adalimumab 40mg every two weeks, or a placebo injection every two weeks. The patients who were randomised to Olokizumab every four weeks also received a placebo injection every two weeks to keep the treatment fully blinded.
Brenda continues: “After Christmas, I started on the trial. Before starting on a trial you are given an extensive medical. I had my heart checked and had blood tests and chest x-rays. Because I’d had pneumonia I had extensive x-rays to make sure my lungs were ok.
“I came to the hospital every two weeks for six months to have the injection and be examined. I saw the research nurses Cath and Ruby and Dr. Batley. On each day I was given the injection I had my blood pressure checked and had blood tests. I had to answer a series of questions on an iPad, questions asked what activities I could do, for example, can you get out of the car without being helped? Can you walk upstairs quickly? Can you open a jar? At the beginning of the trial I had difficulty with these activities and now they are not so much a problem.
“I do not know which treatment I received but now I have almost no rheumatoid arthritis symptoms. The six months went so well that the company asked if I would continue to the longer-term open-label extension study.”
The second trial Brenda is a part of is the CREDO-4 study. This study evaluates how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with rheumatoid arthritis who have previously taken part in and completed 24 weeks of blinded treatment in one of the core studies - CREDO 1, 2 or 3.
Patients are randomised to one of two treatment groups and either take Olokizumab 64mg every four weeks or Olokizumab 64mg every two weeks. This time the patient and the study team are aware of which group they are randomised to.
For this trial, Brenda and her husband were taught how to inject the medication themselves, with training from research nurses Cath and Ruby, as well as two supervised injections in the clinic. After this training Brenda’s visits are now eight or 12 weeks apart with Brenda injecting at home between each visit as well as at clinic visits. Brenda will receive treatment for a year and a half as part of CREDO-4 as well as a six month follow up period, which means that she will have spent a total of two and a half years as a rheumatology trial patient.
Brenda continues: “Being on this trial has been life-changing. Having rheumatoid arthritis stops you from doing so much. Before I started the trial the pain was horrendous. Last year I was not able to work on my garden or allotment, but this year I cleared all the weeds in the garden and our garage is full of vegetables from my allotment. Friends and family have noticed the difference in me. Before I could not lift my three-year-old granddaughter, now when I see her, the first thing I do is pick her up.
“Excitedly I would say to others that they must take part in research, you do not have anything to lose but a lot to gain. If the treatment being investigated does not work, it does not work but you need to try.”
Dr. Mike Batley said: “Brenda was offered the opportunity of trial medication and has done really well with this therapy. It is a pleasure to have such a great partnership between the pharmaceutical industry, the NHS and most of all our patients.”