Polymyalgia Rheumatica MedDRA version: 9.1 Level: LLT Classification code 10036099 Term: Polymyalgia rheumatica
Conditions
Interventions
Trade Name: Lodotra
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of PMR by standard criteria (Bird criteria, see below) -Patients are over 50 but less than 85 years old. -No or stable NSAID or analgesic therapy for at least 7 days. -Currently active disease (defined by checking acute phase response in the blood) Bird Criteria will be used. 3 criteria or more are required to make the diagnosis: • Bilateral shoulder pain/stiffness • Duration onset 40 mm/h, CRP >10 or Plasma viscosity >1.72 • Stiffness >1 h • Age >65 years • Depression and/or weight loss • Bilateral upper arm tenderness Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Currently on oral glucocorticoid treatment or taken within 2 months • Parenteral glucocorticoid treatment with the last 2 months • Pregnancy and lactation • Inflammatory diseases such as inflammatory bowel disease, colitis, asthma • Co-existent giant cell arteritis • Other auto-immune diseases • Cancer • Hypothalamic pituitary adrenal disease • Infections, treatment with antibiotics within the past 6 weeks • Significant renal disease (creatinine >150 µmol/L) • Significant hepatic impairment • Participation in a clinical trial within the past 30 days • Working shift employee • Jet lag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To look for circadian variations in IL-6 in 24 patients with newly diagnosed Polymylagia Rheumatica (PMR) who have not received glucocorticoid treatment. 2. To compare within individual patients the relationship between 24 hour variations in the concentrations of pro- and anti-inflammatory cytokines IL-6, IL-1ß, IL-4, TNF-a and IL-10 and in HPA axis (cortisol) in 12 patients with newly diagnosed PMR before and after treatment with TRT prednisone 7mg for 2 weeks and 12 patients treated with standard release prednisolone 7mg. Our hypothesis is that night time administration will result in a significantly greater reduction in overnight IL-6 with a concomitant substantial reduction in morning stiffness compared to morning administration. ;Secondary Objective: The secondary aim of this study will be to compare the response to TRT prednisone with the clinical and cytokines changes after 2 weeks of the standard treatment with prednisolone 15mg in the morning.;Primary end point(s): Circadian variaton in serum IL-6. | — |
Countries
United Kingdom
Outcome results
None listed