E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
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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 |
The primary objective of this study is to evaluate if 12 weeks of treatment with 5 mg Lodotra® administered in the evening is superior to placebo in terms of the ACR20 responder rate. |
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E.2.2 | Secondary objectives of the trial |
The key secondary objective of this study is to evaluate if 12 weeks of treatment with 5 mg MR prednisone (Lodotra®) administered in the evening is superior to placebo in terms of the relative reduction of morning stiffness. Additional secondary objectives of this study are to compare 12 weeks of treatment with 5 mg Lodotra® administered in the evening with placebo in terms of efficacy, quality of life and safety.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Provide written informed consent •Have a documented history of RA (sero-negative or sero-positive) in agreement with the ACR criteria including the symptoms morning stiffness, joint pain, tender and swollen joints, inflammatory state with elevated erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) •Be on disease modifying anti-rheumatic drugs (DMARD) treatment for RA for at least 6 months, with a stable dose for at least 6 weeks prior to screening visit (Visit 0) •Have duration of morning stiffness of at least 45 minutes •Have swollen joint count of 4 or more out of 28 •Have tender joint count of 4 or more out of 28 •Aged 18 to 80 years •Female patients of childbearing potential must be using a medically accepted contraceptive regimen •Able to perform the required study procedures including handling of medication containers and diaries
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E.4 | Principal exclusion criteria |
The presence of any of the following will exclude a patient from study enrolment: •Suffering from another disease, which requires glucocorticoid treatment, e.g. asthma, neurodermatitis •Synovectomy within 4 months prior to study start •Use of glucocorticoids (by any route) within 6 weeks prior to screening visit (Visit 0) •Prior use of biologicals: TNFα inhibitors within 3 months prior to screening visit (Visit 0) or other compounds within 1 year prior to screening Visit 0 •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation •Pregnancy or nursing •Participation in another clinical study (use of an investigational product) within 30 days preceding visit (Visit 0) •Re-entry of patients previously enrolled in this trial •Suspected inability or unwillingness to comply with study procedures •Alcohol or drug abuse •Requirement of nonpermitted concomitant medication •Known hypersensitivity to prednisone or predniso(lo)ne •Any contraindication for low dose prednisone treatment •Significant renal impairment (serum creatinine > 150 µmol/L) •Significant hepatic impairment (investigator’s opinion) •Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable will be the ACR20 responder rate after 12 weeks of double-blind treatment with the study medication. Responders will be defined as those whose improvement from baseline to endpoint (12 weeks) fulfill all three of the following criteria: •= to or >20% reduction in the tender joint count (0–28) •= to or >20% reduction in the swollen joint count (0–28) •= to or >20% reduction in 3 of 5 of the following additional measures: -Patient assessment of pain (VAS) -Patient’s global assessment of disease activity (VAS) -Physician’s global assessment of disease activity (VAS) -HAQ-DI -CRP or ESR as acute-phase reactant. CRP will be used if the CRP value at baseline (Visit 1; Week 0) is above the ULN; otherwise the ESR value will be used to calculate the ACR20 responder status.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 | No |
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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End of trial is May 2009. |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 15 |