Rheumatoid arthritis
Conditions
Interventions
Product Name: Prednisone
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration
Sponsors
United Bristol Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have rheumatoid arthritis by the criteria of the American College of Rheumatology: Are over 50 but less than 80 years old (over 50 avoids hormonal changes due to the menopause). Have active disease as evidenced by; three or more swollen joints; three or more tender joints; morning stiffness at least 45mins; pain at least 30mm on a 100mm VAS ESR at least 29mm in 1st h or CRP at least 15mg/L Stable DMARD therapy (or no therapy) for at least 28 days Stabel NSAID/analgesic therapy for at least 7 days (These are the same criteria as used in a large randomised controlled trial of this medication currently being conducted in Germany) 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: The following criteria exclude patients who might develop adverse reactions from even small doses of glucocorticoid, or who have other conditions which might affect the things being measured in the study: Pregnancy and lactation Participation in a clinical trial within the past 30 days Presence of contraindication of corticosteroids Known hypersensitivity to prednisone/prednisolone Parenteral treatment with corticosteroids or crystalloid injection into joints within the past 3 months Other diseases which require corticoid treatments Inflammatory diseases, such as IBD, Collitis, Crohn's disease, Asthma Other auto-immune diseases Cancer Infections, treatment with antibiotics in the past 6 weeks Requirement of non-permitted concomitant medication Consumption or Benzodiazepines, Antidepressants, Antipsychotic drugs, Antihistaminic drugs TNF inhibitors Working shift emplotee Jet lag Significant renal disease (creatinine>150 micro mol/L) Significant hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out if overnight variations in blood levels of chemicals (called cytokines) which cause or reduce inflammation in rheumatoid arthritis are changed by taking a new timed release tablet that provides a dose of the steroid prednisone in the middle of the night.;Secondary Objective: To find out if blood cytokine levels are related to the hormones of the hypothalamic-pituitary-adrenal axis, which is the body's natural system for making and controlling steroid production.;Primary end point(s): Changes in the pattern of cytokines and HPA axis constituents before and after patients have been taking nightime prednisone. The principle measures will be Interleukine-6 and cortisol. The main analytical outcome will be the relative size and timing of the rise in levels of these measures between 2am and 9am. | — |
Countries
United Kingdom
Outcome results
None listed