E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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) |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial will be when the last patient completes the last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |