E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erithematosus (SLE) patients with a history of renal disease. |
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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 | 10042945 |
E.1.2 | Term | Systemic lupus erythematosus |
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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 determine whether Abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a hostory of SLE renal disease. |
|
E.2.2 | Secondary objectives of the trial |
To determine whether treatment with Abetimus sodium is more effective than placebo in reducing proteinuria and in delaying time to all mejor SLE flares. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males or females between 12 and 70 years old inclusive. Female patients must have a negative pregnancy test. Diagnii'osis of SLE established when > or equal 4 of the 11 criteria are met based on the classification of the American College of Rheumatology. At least one documented episode of active SLE renal disease within 4 years prior to randomization. Elevated anti dsDNA antibody concentration at pre-screening visit as measured by Farr assay. |
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E.4 | Principal exclusion criteria |
Active SLE renal disease in the 3 months prior to randomization. An increase in the anti sdDNA antibody concentration of more than 50% of the former sample. Use of the following therapeutics: prednisone, alkylating agents, TNF inhibitors, cyclosporine, plasmapheresis, intravenous immnoglobulin, prosorba column, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, rituximab. laboratory values: leukocyte count < 2000 cells/mm3, platelet count < 50000 cells/mm3, hemoglobin < 8.5 gr/dl transaminases > 3X the upper limit of normal, serum creatinine > 3.5 mg/dL. Immunodeficiency syndrome within 5 years. Evidence of current abuse of drugs or alcohol. Serious cardiac disease. Patients has previously undergone organ transplantation. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the time to first renal flare. Safety and tolerability endpoints are the collections of adverse experiences, laboratory parameters, reasons for premature study termination and cause of death. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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 | 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
|
I pazienti arruolati nello studio devono essere seguiti dopo 30, 60 e 90 giorni l'ultima dose di farmaco al fine di registrare tutti i SAE che si sono verificati nel frattempo. I SAE verranno seguiti fino alla loro risoluzione o stabilizzazione. |
|
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 | 10 |
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 | 10 |