Rheumatoid Arthritis (RA) Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
The study uses a delayed (timed) release formulation of prednisone which will release the full dose of the active drug during sleep after a lag time of 4 hours, allowing the patient to take the medica
Sponsors
United Bristol Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have rheumatoid arthritis by the criteria of the American College of Rheumatology 2. Are over 50 but less than 80 years old 3. Have active disease as evidenced by: 3.1. Three or more swollen joints 3.2. Three or more tender joints 3.3. Morning stiffness at least 45 minutes 3.4. Pain at least 30 mm on a 100 mm Visual Analogue Scale (VAS) 3.5. Erythrocyte Sedimentation Rate (ESR) at least 29 mm in first hour or C-Reactive Protein (CRP) at least 15 mg/L 4. Stable Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy (or no therapy) for at least 28 days 5. Stable Non-Steroidal Anti-Inflammatory Drug (NSAID)/analgesic therapy for at least seven days It is anticipated that the ratio of female to male patients will be approximately 2:1, in accordance with the pattern of disease occurrence. To be safe, we will invite women of childbearing potential to take part in the study only if they are using contraception.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation 2. Participation in a clinical trial within the past 30 days 3. Presence of contraindication of corticosteroids 4. Known hypersensitivity to prednisone/prednisolone 5. Parenteral treatment with corticosteroids or crystalloid injection into joints within the past three months 6. Other diseases which require corticoid treatments 7. Inflammatory diseases, such as Irritable Bowel Disease (IBD), Colitis, Crohn's Disease, Asthma 8. Other auto-immune diseases 9. Cancer 10. Infections, treatment with antibiotics within the past six weeks 11. Requirement of non-permitted concomitant medication 12. Consumption of benzodiazepines, antidepressants, antipsychotic drugs, antihistaminic drugs 13. Tumour Necrotising Factor - alpha (TNFa) inhibitors 14. Working shift employee 15. Jet lag 16. Significant renal disease (creatinine greater than 150 µmol/L) 17. Significant hepatic impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in overnight pattern of plasma cortisol and interleukin-6 concentrations, determined at baseline and two weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard assessment tools will be used to assess the state of the patient's arthritis. These assessments will be: 1. Swollen and tender joint counts 2. Pain (visual analogue scale) 3. Morning stiffness (minutes) 4. Patient's opinion of condition 5. Clinician's opinion of condition 6. Health Assessment Questionnaire 7. The Multidimensional Assessment of Fatigue scale 8. Hospital Anxiety and Depression Scale The secondary outcome measures are determined at baseline and two weeks. | — |
Countries
United Kingdom
Outcome results
None listed