Ulcerative Colitis Clinical Trial
MAC Clinical Research are currently conducting a trial to test a potential new treatment for moderate to severe ulcerative colitis (UC).
Improving quality of life
Key Information
Reimbursement
Appropriate compensation will be provided, plus reasonable travel expenses
Gender and Age
Males and Females, aged 18 and over
Clinics
Merseyside
Health Check
Receive a free comprehensive health check
Register Your Interest
What Happens Next?
1. Sign Up
Register your interest on our website or over the phone
2. We'll Call You
Our study specialists will speak with you to discuss your health and check if the trial is suitable for you
3. Eligible?
If eligible, you will be booked in for a Chat where you'll receive a Patient Information Sheet (PIS)
4. Medical History
If you decide to take part, our medical team will obtain a copy of your medical history from your GP
5. Health Check
You will attend a free comprehensive health check with a MAC doctor and your eligibility will be confirmed
6. Enrollment
You will be enrolled onto the clinical trial and attend scheduled visits (Travel expenses or transport to clinic provided)
About this Ulcerative Colitis Clinical Trial
MAC Clinical Research are currently conducting a clinical trial to test a potential new treatment for ulcerative colitis (UC). UC is a chronic inflammatory disease of the rectal & colonic mucosa which is characterised by periods of remission and relapse, or ‘flare-ups’. Autoimmune and inflammatory diseases such as UC can happen when a person’s immune system becomes unbalanced.
The investigational medicine, is a monoclonal antibody (antibodies that act like human antibodies in your immune system) that may reduce inflammation associated with ulcerative colitis.
– Male or female aged 18 and over
– Diagnosis of ulcerative colitis, as confirmed by a GP or specialist
– Active ulcerative colitis – currently passing at least some blood during bowel movements
– An inadequate response or intolerance to at least one previous UC treatment (additional criteria may apply), OR currently receiving oral corticosteroids, Azathioprine, or 6-mercaptopurine for the treatment of UC (minimum dose levels will apply)
Eligible patients will receive a health screen and study participation will be in collaboration with your treating physician.
– Diagnosis of Crohn’s disease or indeterminate colitis
– Any previous bowel removal for UC or planned UC surgery (including colostomy, ileostomy, proctocolectomy or total colectomy)
(Further restrictions may apply depending on your medical history).
Eligible participants will enter a 12-week Induction Period where they will receive the study medication or placebo by intravenous (into the vein) infusion and have a 50% chance of receiving either the study medication or placebo (a ‘dummy drug’). Following the Induction Period participants will enter an Open Label Extension Period (on completion of the trial, patients may be invited to continue taking the investigational medication for a further period) of up to 38 weeks, where there will be no further placebo administered.
There will be up to 25 outpatient visits, including endoscopies with biopsies and a chest x-ray, over a period of approximately 67 weeks. Dosing will take place every 4 weeks on average.
Appropriate compensation will be provided, plus reasonable travel expenses.
