Timed Release Tablet Prednisone in Polymyalgia Rheumatica
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
Polymyalgia Rheumatica (PMR) is a disease that usually affects older people. Patients
complain of stiffness and pain around the shoulders and hips. The stiffness is more severe in
the morning.
Research in Rheumatoid Arthritis (RA), which is also much worse in the mornings, has shown
that IL-6 (a chemical messenger) peaks in the morning with very low levels in the evening.
This may explain why stiffness is most severe in the morning. The investigators have recently
shown that timed release tablet (TRT) prednisone reduced morning IL-6 levels close to normal
in RA patients.
In PMR, IL-6 levels are high. Given that both RA and PMR have the same variation of symptoms
(worse in the morning); it's likely that PMR patients have the same variation in IL-6 levels.
In a pilot study of 4 patients conducted within our department, IL-6 levels did, indeed, show
a pattern similar to that found in RA patients, but the number of patients is small and the
results need to be confirmed.
PMR is treated with moderate doses of glucocorticoid for about 2 years. While generally
abolishing symptoms, these doses are very likely to cause adverse effects such as high blood
pressure, weight gain and diabetes. These side effects are much less frequent when lower
doses are used but these are not sufficient to control PMR using traditional dosing regimes.
Therefore, the investigators wish to investigate whether TRT prednisone in PMR will reduce
IL-6 and morning symptoms similar to those in RA. The investigators think that it will do so,
and will achieve symptomatic relief at a lower dose. If this is the case, then treating
patients with lower doses may mean reduced risk of glucocorticoid induced side effects in the
future.
Patients will be recruited through the outpatient clinics at the University Hospitals
Bristol, NHS Foundation Trust, Rheumatology Centre. Each patient will give fully informed
consent after being given details of the study and a patient information sheet. The research
doctor will take the consent 2-5 days after this information has been provided and with the
presence of a witness. The study will consist of the collection and analysis of sequential
blood samples over a 24 hour period on 2 occasions 2 weeks apart, taking TRT prednisone 7 mg
/ standard release prednisolone 7 mg for the intervening period. The investigators will aim
to recruit 12 patients in each arm. A single blood sample will be taken when the patient
comes for a routine review 2 weeks later.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University Hospitals Bristol and Weston NHS Foundation Trust University Hospitals Bristol NHS Foundation Trust