EUCTR2021-001973-21-SE进行中（未招募）1 期
A long-term extension of Study GNC-401 with temelimab in patients with Relapsing forms of Multiple Sclerosis (RMS) under treatment with rituximab - ProTEct-MS Extension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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. The patient has given written informed consent to participate in the study;
- •2. Current diagnosis of RMS, based on the McDonald 2017 criteria;
- •3. Patients must have completed study GNC-401. Completion is defined as having performed the Week 48 assessments of study GNC-401;
- •4. Have no clinical (relapses) or MRI signs (=2 new T2 lesions of >10 mm diameter) of acute MS disease activity, based on the Week 48 MRI of study GNC-401, or, if yes, been retreated prior to study entry with rituximab;
- •5. Have a B-cell count =0.05 x 10E9 CD19 cells/L (assessed at the end of study GNC-401, or before inclusion in this study GNC-402 (available result from routine clinical practice); if not retreated with rituximab before entering study GNC-402, monthly B-cell count
- •will be executed and retreatment will be considered by the treating physician when B-cells are >0.05 x 10E9 CD19 cells/L);
- •6. Be willing and able to follow all study procedures and assessments according to the study protocol.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The emergence of any disease diagnosis during the course of study GNC-401 that is not due to MS and could better explain the patient’s neurological signs and symptoms;
- •2. Body weight =40 kg;
- •3. Contraindication to continue rituximab therapy;
- •4. Has received rituximab less than 12 days prior to study entry;
- •5. Use of any of the following medications since Week 48 of the GNC-401 study:
- •a. IFN-ß, glatiramer acetate, IVIG, dimethyl fumarate or teriflunomide;
- •b. Natalizumab, mitoxantrone, cladribine, alemtuzumab, cyclophosphamide,
- •systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation;
- •c. Highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine;
- •d. Any experimental drugs for the treatment of MS;
- •6. CTCAE Grade 2 or greater lymphopenia (based on Week 48 of study GNC-401);
- •7. Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study, including:
- •a. Diagnosis or history of schizophrenia;
- •b. Current diagnosis of moderate to severe bipolar disorder, major depressive disorder, major depressive episode, history of suicide attempt, or current suicidal ideation;
- •c. Current or past (within the last 2 years) alcohol or drug abuse;
- •8. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4);
- •9. Known inability to undergo an MRI scan;
- •10. Contraindications to the use of 5% glucose solution for infusion;
- •11. Inability to follow study instructions, or complete study assessments, as defined by the protocol;
- •12. Any history of cancer with the exceptions of basal cell carcinoma and/or carcinoma in situ of the cervix, and only if successfully treated by complete surgical resection, with documented clean margins and any medically unstable condition as determined by the Investigator;
- •13. Legal incapacity or limited legal capacity;
- •14. Pregnant or breastfeeding women;
- •15. Abnormal liver function tests: AST or ALT >2 times ULN, or conjugated bilirubin >2 times ULN, or AP or GGT >3 times ULN;
- •16. FPCBP or PMP, not willing to use highly effective contraceptive methods throughout the study duration and for at least 5 months after the last study treatment. The Investigator must inform the participant about the risks of not using an effective method of birth control during the course of the study and they should discuss with
- •the participant the most appropriate method.
研究者
相似试验
终止
2 期
A Long-term Extension of Study GNC-401Multiple SclerosisNCT05049161GeNeuro Innovation SAS33
进行中（未招募）
不适用
Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2012-002760-27-HUovartis Pharma AG345
进行中（未招募）
不适用
Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisRheumatoid arthritisEUCTR2012-002760-27-SKovartis Pharma AG345
进行中（未招募）
不适用
Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisRheumatoid arthritisEUCTR2012-002760-27-ESovartis Farmaceutica, S.A.345
进行中（未招募）
不适用
Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritisRheumatoid arthritisEUCTR2012-002760-27-BGovartis Pharma Services AG345