EUCTR2015-005749-30-SE进行中（未招募）1 期
A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with oculo bulbar, bulbar or generalized MG = 18 years of age and not more than 12 months ago estimated the onset of symptoms of generalized symptoms or neurophysiological detection of generalized disease.
- •2. The diagnosis of MG should be produced by the following tests:
- •Clinical neurological status with motor effects consistent with MG, and at least two of the following:
- •A positive serological test for anti-acetylcholine receptor antibodies (AChR),
- •b. For MG typical deviation during neurophysiological testing of the neuromuscular transmission with single fiber electromyography (SFEMG) and / or repetitive nerve stimulation (RNS)
- •c Positive choline esterase blocker response, e.g. edrophonium and/or oral cholinesterase inhibitors, as judged by the treating physician.
- •3. MGFA clinical classification Class II to IV at screening.
- •4. Quantitative MG score = 6 at screening
- •5. Women of childbearing potential must have a negative pregnancy test.
- •6. Patients must have given written informed consent.
- •7. Patients must be able and willing to comply with all study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Weakness that only affect ocular or periocular muscles (MGFA class I).
- •2. MG crisis at screening (MGFA Class V)
- •3. Already implemented thymectomy. In order to avoid difficulties to evaluate the effect of the study drug, thymectomy, in cases where it is indicated, should be scheduled to the follow-up period, ie after the first 24 weeks.
- •4. Strong suspicion of thymoma, where a thymectomy is indicated within 24 weeks according to the treating physician.
- •5. Active tumor disease, if not adequately treated.
- •6. Pregnancy and lactation.
- •7. Ongoing acute or chronic viral or systemic bacterial infections including HIV, latent hepatitis B, which is clinically significant, according to the study doctor's opinion and not treated with appropriate antibiotics / antiviral drug.
- •8. Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.
- •9. 9. Previously use of immunosuppressive drugs, including rituximab, azathioprine, cyclosporine and MMF. Prednisolone at a dose of =40mg / d within 3 months and IVIG and PLEX 12 months of the screening date is not an exclusion criterion. Also note that this does not apply to treatment with immunosuppressive drugs / corticosteroids (except rituximab) in another indication than MG, provided that it is > 12 months since the treatment ended.10. Hypersensitivity to the active substance or to murine proteins or to any of the excipients of the study drug
- •11. Participation in another trial to study drug or exposure to any other study drugs, study product or study procedures within 30 days prior to screening.
- •12. Any medical condition which, according to the study physician's opinion, may interfere with the patient's participation in the study, pose any additional risk to the patient, or that complicate the assessment of patients
研究者
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