E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 relate clinical response in RA patients treated with prednisolone, with defined biochemical markers of inflammation |
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E.2.2 | Secondary objectives of the trial |
•To determine pharmacokinetics of oral prednisolone in RA patients, and its relationship to the clinical response measures and pharmacodynamic measure of LPS-induced cytokine release. •To evaluate the effect of prednisolone on whole blood gene expression in RA patients, as measured by microarray analysis and quantitative RT PCR. •To relate exposure to prednisolone in RA patients to levels of biochemical markers of bone formation and resorption (serum CTX I, NTX I, osteocalcin, P1NP). •To evaluate the effect of prednisolone on protein expression in RA patients as measured by protein array.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients between 25 and 75 years of age who meet the ACR criteria for diagnosis of rheumatoid arthritis, and in whom treatment with prednisolone is clinically indicated. 2. Active rheumatoid arthritis. 3. Currently on a stable treatment regimen. 4. The subject is capable of giving informed consent. 5. Willingness to continue on their current treatment regimen for the 2 weeks duration of the study with no change in dosage. 6. Women of childbearing potential willing to use dual barrier method contraception during the study period.
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E.4 | Principal exclusion criteria |
1. Any clinically relevant abnormality identified on the screening medical assessment (including medical history) that is considered by the investigator to represent a risk to the patient's safety during the study 2. Currently diagnosed with osteoporosis or on bisphosphonate therapy, or prior history of vertebral or compression fracture. 3. Diabetes or heart failure 4. Myocardial infarction within 6 months prior to dosing 5. Renal insufficiency (serum creatinine greater than 1.8) 6. History of untreated gastric or duodenal ulcer within 6 months prior to dosing 7. Use of Remicade (infliximab) or Humira (adalimumab) within 90 days prior to first dose of study medication. Use of Enbrel (etanercept) within 4 weeks prior to first dose of study medication. Use of Kineret (anakinra) within 1 week prior to first dose of study medication 8. Use of investigational biological therapies within 90 days prior to dosing and during the study 9. History of HIV disease, immunodeficiency, or use of immunosuppressants cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, or azathioprine within 30 days prior dosing and during the study 10. Daily use of opiate analgesics in excess of: 180 mg codeine /day, propoxyphene 400 mg /day, oxycodone >30mg/day, morphine >60mg/day, or hydrocodone >30mg/day, are not permitted. 11. An acute systemic infection within 14 days prior to dosing 12. Pregnant or nursing women |
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E.5 End points |
E.5.1 | Primary end point(s) |
•DAS28 score (composed of swollen and tender joint counts at 28 sites, General Health VAS score, and ESR). •The levels of selected markers of inflammation, which may include (but are not limited to) ESR, C-reactive protein, IL-6, Rheumatoid factor and soluble TNF-R
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |