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| Circadian variations in cytokines and the effect of timed release tablet prednisone in rheumatoid arthritis |
| Source of record | UK Trials |
| ISRCTN | ISRCTN17552423 |
| Date ISRCTN assigned | 04/10/2007 |
| Local reference number(s) | ME/2005/2073 |
| Public title | Circadian variations in cytokines and the effect of timed release tablet prednisone in rheumatoid arthritis |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Rheumatoid Arthritis (RA) |
| Study hypothesis | Rheumatoid Arthritis (RA) is a systemic, inflammatory condition causing joint pain and swelling, disability, and psychological distress. To document overnight variations of serum pro-inflammatory and anti-inflammatory cytokines in 12 volunteers with rheumatoid arthritis on one night before and one night during treatment with a Timed Release Tablet (TRT) containing 5 mg prednisone, and to relate blood cytokine levels to biogenic amines and the hormones of the hypothalamic-pituitary-adrenal axis. |
| Design/methodology | Non-randomised, non-controlled interventional single centre study of patients before and after two weeks treatment with night time prednisone |
| Research ethics review | Approval received from the North Somerset and South Bristol Research Ethics Committee (REC) on the 28th November 2005 (ref: 054/Q2006/185). |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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 (TNFα) inhibitors 14. Working shift employee 15. Jet lag 16. Significant renal disease (creatinine greater than 150 µmol/L) 17. Significant hepatic impairment |
| Patient information material | |
| Anticipated start date | 15/06/2006 |
| Anticipated end date | 14/06/2008 |
| Status of trial | Ongoing |
| Target number of participants | 12 |
| 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 medication at a convenient point in time, namely at 22:00 hours +/- 30 minutes. Intervention: Timed-Release Tablet (TRT) prednisone 5 mg, one tablet taken at 22.00 each evening for 12 - 16 nights (depending on the convenience of the final study night for the patient). There is no study follow-up after the end of medication. |
| Primary outcome measure(s) | Changes in overnight pattern of plasma cortisol and interleukin-6 concentrations, determined at baseline and two weeks. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | Nitec Pharma AG (Switzerland) |
| Sponsor name | United Bristol Healthcare NHS Trust (UK) |
| Sponsor details | Marlborough Street Bristol United Kingdom BS2 8HW |
| Sponsor telephone | +44 (0)117 928 3473 |
| Sponsor fax | +44 (0)117 928 3524 |
| Sponsor email | Maria.Palmer@ubht.swest.nhs.uk |
| Sponsor website | http://www.ubht.nhs.uk/R&D/ |
| Contact name | Prof John Kirwan |
| Contact details | Academic Rheumatology Unit Bristol Royal Infirmary Bristol United Kingdom BS2 8HW |
| Contact telephone | +44 (0)117 928 2904 |
| Contact fax | +44 (0)117 928 3841 |
| Contact email | John.Kirwan@Bristol.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17552423 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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