Tolerance and Efficacy of Rituximab in Sjogren's Disease
Parole chiave
Astratto
Descrizione
TARGET POPULATION Inclusion criteria : Patients will be eligible if :
they fulfill the new American-European Consensus Group criteria for pSS and have :
- a recent (less than 10 years) and active disease as assessed by :
- values > 50 mm on 2 of 4 visual analogue scales (VAS) (0-100mm) that evaluated global scores of the disease (activity of the disease including extra glandular manifestations), pain, sicca syndrome and fatigue over the last week.
- Rheumatoid factor or SSA>1.5N or cryoglobulinemia or hypergammaglobulinemia or high level of beta2 microglobulinemia or hypocomplémentemia.
- and/or at least one of the following severe signs: parotidomegaly, arthritis, purpura, pulmonary involvement, tubulopathy, neurological involvement, thrombocytopenia.
Additional inclusion criteria will be as follows:
- informed consent
- age 18-80 years,
- stable non-steroidal anti-inflammatory drugs
- and no prescription of immunosuppressive agents for at least 4 weeks prior to inclusion
- Use of a reliable mean of contraception (for patients of reproductive potential)
Exclusion criteria :
Patients should be excluded if they have a secondary SS, if they received cytotoxic drugs during the previous 4 months, if they have severe renal or haematological failure, a history of cancer, hepatitis B or C, HIV, tuberculosis, severe diabetes or any other chronic disease or evidence of infection, if they have had severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or if they are unable to understand the protocol. Other : neutrophil count < 1.5 x 103/L, live/attenuated vaccine within 28 days prior to baseline, pregnancy, breast feeding,
Date
| Ultimo verificato: | 02/28/2015 |
| Primo inviato: | 08/21/2008 |
| Iscrizione stimata inviata: | 08/21/2008 |
| Primo pubblicato: | 08/24/2008 |
| Ultimo aggiornamento inviato: | 03/03/2015 |
| Ultimo aggiornamento pubblicato: | 03/04/2015 |
| Data di inizio effettiva dello studio: | 02/29/2008 |
| Data di completamento primaria stimata: | 12/31/2011 |
| Data stimata di completamento dello studio: | 12/31/2012 |
Condizione o malattia
Intervento / trattamento
Drug: 1
Drug: 2
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Experimental: 1 Rituximab | Drug: 1 2 * 1g of Rituximab at the 1st day and at the 14th day. |
| Placebo Comparator: 2 Placebo | Drug: 2 2* 250ml of NaCl 0.9% or Glucose 5% at the 1st day and at the 14th day. |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion Criteria: - they fulfill the new American-European Consensus Group criteria for pSS and have : - a recent (less than 10 years) and active disease as assessed by : - values > 50 mm on 2 of 4 visual analogue scales (VAS) (0-100mm) that evaluated global scores of the disease (activity of the disease including extra glandular manifestations), pain, sicca syndrome and fatigue over the last week. - Rheumatoid factor or anti SSA>1.5N or cryoglobulinemia or - hypergammaglobulinemia or high level of beta2 microglobulinemia or - hypocomplémentemia. - and/or at least one of the following severe signs: - parotidomegaly, - arthritis, - purpura, - pulmonary involvement, - tubulopathy, - neurological involvement, informed consent age 18-80 years, stable non-steroidal anti-inflammatory drugs and no prescription of immunosuppressive agents for at least 4 weeks prior to inclusion Use of a reliable mean of contraception (for patients of reproductive potential) Exclusion Criteria: - Patients should be excluded if they have a secondary SS, - if they received cytotoxic drugs during the previous 4 months, - if they have severe renal or haematological failure, a history of cancer, hepatitis B or C, HIV, tuberculosis, severe diabetes or any other chronic disease or evidence of infection, - if they have had severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - or if they are unable to understand the protocol. - Other : neutrophil count < 1.5 x 103/L, live/attenuated vaccine within 28 days prior to baseline, pregnancy, breast feeding, |
Risultato
Misure di esito primarie
1. 30% improvement between in the values on 2 of the 4 VAS measuring global scores of the disease (activity of the disease), joint pain, fatigue, and dryness. [24 weeks]
Misure di esito secondarie
1. Variations from baseline to week 24 of clinical, biological and histological data [24, 36 and 48 weeks]
