Tolerance and Efficacy of Rituximab in Sjogren's Disease
キーワード
概要
説明
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,
日付
| 最終確認済み: | 02/28/2015 |
| 最初に提出された: | 08/21/2008 |
| 提出された推定登録数: | 08/21/2008 |
| 最初の投稿: | 08/24/2008 |
| 最終更新が送信されました: | 03/03/2015 |
| 最終更新日: | 03/04/2015 |
| 実際の研究開始日: | 02/29/2008 |
| 一次完了予定日: | 12/31/2011 |
| 研究完了予定日: | 12/31/2012 |
状態または病気
介入/治療
Drug: 1
Drug: 2
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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, |
結果
主な結果の測定
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]
二次的な結果の測定
1. Variations from baseline to week 24 of clinical, biological and histological data [24, 36 and 48 weeks]
