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 |
The primary objective is to explore in non-inferior efficacy of Myfortic administered at a dose of 2160mg/day in combination with reduced corticosteroid regimen compared to the combination with a standard corticosteroid regimen where efficacy measure is defined as the proportion of patients in complete remission after 24 weeks of treatment |
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E.2.2 | Secondary objectives of the trial |
To assess/evaluate the following main (not complete list) secondary objectives: - Proportion of patients in complete remission at 12 weeks and partial remission of lupus flares at 12 weeks and at 24 weeks. - The corticosteroid use as cumulative dose until 12 and 24 weeks of treatment, also doses at baseline, 12 and 24 weeks - Overall disease activity using BILAG and SLEDAI activity indices at week 24 - Proportion of patients with mild SLE flare at 12 and 24 weeks and with moderate/severe SLE flare at 12 and 24 weeks - Organ damage, utilising the SLICC/ACR Damage Index at 24 weeks - Renal function (serum creatinine, creatinine clearance, GFR and the urine protein/ creatinine ratio - Patients with no therapeutic response at 12 and 24 weeks - Patients with treatment failure at 12 and 24 weeks - Proportion of patientswith AEs, SAEs and infections during the course of the study
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female with SLE (at least classification 4 of ACR) - Aged >/ 18years - Proliferative lupus nephritis cassified as ISN/RPS class III or IV - Renal biopsy must be performed during the last 12 mont preceding the lupus nephritis flare -Proteinuria defined as >0.5gm urine protein per gram urine creatinine - Clinical activity defined by one or more of the following changes in renal function: serum creatinine>1mg/dl / microscopic haematuria defined as > 5 rbcs per high power field / presence of cellular casts |
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E.4 | Principal exclusion criteria |
- patients with serum creatinine on repeated testing >3mg/dl or calculated creatinine clearance of < 20ml/mn - Patients having received an iv corticosteroid bolus during the last 3m - Patients having received MMF within the preceding 6m -Use of monoclonal antibody therapy within the past 30 days - Pregnant or nursing women - women of child-bearing potential who are planning to become pregnant - Use of other investigational drugs within im of enrollment - History of hypersensitivity to study drugs - History of malignancy within the past 5 years |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study is to explore the non-inferior efficacy of Myfortic® administered at a dose of 2160 mg/day in combination with reduced CS regimen compared to the combination with standard CS regimen where efficacy measure is defined as the proportion of patients in complete remission after 24 weeks of treatment. |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
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) | 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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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 | Yes |
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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Study completed 7 days after the last patient has completed Visit 7. Investigator provides follow-up medical care. Study Completion CRF completed at Week 24 Patients who prematurely discontinue complete the Premature Discontinuation CRF with a subsequent follow-up evaluation form completed at Week 24, except patients prematurely discontinuing due to death, lost to follow-up or patient withdrew consent. Follow-up visit at Week 52 will be performed in all patients. |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |