E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
lupus nephritis ( as part of the disease "Systemic Lupus Erythematosus") |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess, in patients with lupus nephritis, the steroid use of a regimen with myfortic® versus continuation of previous therapy, by assessing the daily steroid doses while maintaining efficacy. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to determine the efficacy and safety of an MPA based, steroid free regimen. This will be evaluated by: • Impact on renal function as assessed by serum creatinine and creatinine clearance • Impact on proteinuria (protein: creatinine ratio) • Maintenance of remission (renal and extra-renal flares) • Incidence of infection • Incidence of adverse events • Evaluation of BILAG (British Isles Lupus Assessment Group) and Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) activity indices Evaluation of organ damage, utilizing the Systemic Lupus Erythematosus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR) Damage Index Assessment of HRQL using MOS SF-36
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The following inclusion criteria must be present at Screening visit 1, prior to randomization 1. Males or females, aged 18 years and over 2. Patients meeting the diagnostic criteria for SLE (Appendix 3), according to ACR guidelines (including screening for anti-dsDNA (antibody to native DNA in abnormal titer) 3. Histological diagnosis of proliferative lupus nephritis (WHO III,IV, or V+III or V + IV). This can be a historical classification, from any timepoint before inclusion into the study 4. Patients treated with standard maintenance therapy (e.g. prednisone 0.5mg/kg or less/day, azathioprine, or cyclophosphamide). Patients who received therapy with mycophenolic acids (MPAs) greater than 12 months prior to inclusion in the study, and who did not discontinue due to MMF side effects, can also be included 5. Patients with persistent proteinuria (>0.5g/day) 6. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
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E.4 | Principal exclusion criteria |
1. Creatinine clearance of < 20ml/min 2. Patients with any clinically significant infection 3. Patients with known hypersensitivity to myfortic® or to drugs with similar chemical structures 4. Patients who have received therapy with mycophenolic acids (MPAs) within 12 months prior to inclusion in the study 5. Patients who have received an investigational drug within four weeks prior to study entry 6. Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin 7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. 8. Patients with active SLE CNS manifestations or a past history of SLE CNS complications ( eg psychosis, grandmal seizures) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable will be the daily dose of corticosteroids over 24 months, measured in mg/kg/day |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
comparator arm is standard maintenance therapy according to local practice |
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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 | Yes |
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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Patients who withdraw for reasons other than withdrew consent, LTFU or death, will be contacted at the end of 24 months following start of study medication, to obtain information on : - current treatment regimen, including steroid dose at the end of the normal study period - number of flares occurring from time of study medication discontinuation - occurrence of malignancies - serum creatinine measurement - urine protein: creatinine ratio HRQL (SF-36)" |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |