Circadian variations in cytokines and the effect of timed release tablet prednisone in rheumatoid arthritis

Completed

Conditions: Rheumatoid Arthritis (RA)
Musculoskeletal Diseases
Rheumatoid arthritis

Registration Number: ISRCTN17552423

Lead Sponsor: nited Bristol Healthcare NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 12

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in overnight pattern of plasma cortisol and interleukin-6 concentrations, determined at baseline and two weeks.

Secondary Outcome Measures

Name	Time	Method
Standard assessment tools will be used to assess the state of the patient's arthritis. These assessments will be: <br>1. Swollen and tender joint counts <br>2. Pain (visual analogue scale) <br>3. Morning stiffness (minutes) <br>4. Patient's opinion of condition <br>5. Clinician's opinion of condition <br>6. Health Assessment Questionnaire <br>7. The Multidimensional Assessment of Fatigue scale <br>8. Hospital Anxiety and Depression Scale <br><br>The secondary outcome measures are determined at baseline and two weeks.