2024-512506-25-00招募中3 期
Rituximab-induced remission in CIDP (ReCIX study)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Remission at 52 weeks after start of RTX, i.e., no need of additional treatment after RTX treatment.
研究概览
简要总结
The main goal of this study is to assess whether adding RTX to a limited period of IVIg treatment leads to long-term remission and discontinuation of IVIg, reducing the inconvenience of regular Ig infusions and related health care costs
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Observational, single arm, prospective study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria Group 1 (new patients): - CIDP according to the EAN/PNS criteria (According to the guideline, symptoms should be developing for at least eight week, mainly to distinguish CIDP from acute polyneuropathy (Guillain Barre syndrome, GBS). However, in some cases, symptoms progress rapidly and lead to severe disability, rendering early treatment necessary. To this end, patients with progressive symptoms for at least four weeks who are strongly suspected of having CIDP may also be included in this trial, provided there are no signs of a different disease (such as GBS or vasculitis neuropathy) - Untreated - Men and women aged between 18 and 80 years - Sufficient CIDP-related disability, as judged by treating physician to warrant IVIg and RTX treatment - Capable of giving signed informed consent
- •Inclusion criteria Group 2 (patients on maintenance treatment IVIg or SCIg): - CIDP according to the EAN/PNS criteria on maintenance treatment (stable dose/interval of at least 4 infusions or 3 months), including one of the following categories: a) patients with wear-off symptoms before next IVIg infusion captured by at least the minimal clinical important difference (MCID) on at least one outcome measure b) patients with a failed withdrawal attempt in the last 12 months captured by at least an MCID on at least one outcome measure c) patients with an increase of IVIg/SCIg dose/interval in the last 12 months leading to improvement by at least the MCID on at least one outcome measure, see below. We will use the most commonly used MCID criteria, namely: 1) one point on the INCAT disability score (1-10); 2) 4 points on a centile score on I-RODS (disability, 1-100); 3) 2 points on the MRC sum score (muscle strength, 0-60) and 4) 8 kPa on Vigorimeter (grip strength, single or both arms, variable range). - Men and women aged between 18 and 80 years - Capable of giving signed informed consent.
排除标准
- •Use of drugs associated with a demyelinating neuropathy in the last six months
- •IVIg interval of once every 6 weeks or more than 6 weeks (applies to Group 2 only)
- •Obesity (BMI > 35)
- •Known active malignancy, (not in remission), currently treated with chemotherapy or immunomodulatory drugs, or with a life expectancy of less than 1 year.
- •History of recurrent/chronic infections
- •Active, severe infections (such as tuberculosis, sepsis and opportunistic infections)
- •Patients in a severely immunocompromised state
- •Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.
- •Serious co-morbidity as judged by treating physician.
- •Pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for the entire duration of the study.
- •No written informed consent
- •Known serious adverse events with previous IVIg or RTX treatment. Hypersensitivity to RTX or any component of the formulation. Hypersensitivity to the human immunoglobulins or to any of the excipients. Known selective IgA deficiency patients who developed antibodies to IgA.
- •Paranodopathy with demonstrated (paranodal) antibodies, previously considered part of CIDP spectrum (in these cases rituximab is preferred treatment)
- •Positive hepatitis B and C serology suggesting active/untreated infection (HBsAg, anti-HB core en anti-HBs and HCV antistof (IgG))
- •Ongoing immunosuppressive treatment for other indications.
- •Immunosuppressive treatment other than (already discontinued) corticosteroids in last 6 months.
结局指标
主要结局
Remission at 52 weeks after start of RTX, i.e., no need of additional treatment after RTX treatment.
Remission at 52 weeks after start of RTX, i.e., no need of additional treatment after RTX treatment.
次要结局
- Stability on treatment at 104 weeks of follow-up.
研究者
Filip Eftimov
Scientific
Amsterdam UMC Stichting
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
Rituximab-induced remission in CIDP (ReCIX study)CTIS2024-512506-25-00Amsterdam UMC Stichting102
招募中
不适用
Real-World Efgartigimod Effectiveness in CIDP: A Prospective StudyCIDPNCT07264426argenx200
招募中
2 期
Evaluation of the efficacy and safety of Rituximab in patients with Amyotrophic Lateral Sclerosis (ALS)2022-502743-35-00Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.52
招募中
4 期
REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in relapsing PolyMyalgia RheumaticaPolymyalgia rheumatica2024-513545-37-00Sint Maartenskliniek Stichting174
招募中
3 期
Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without
Selinexor in Patients with Diffuse Large B-Cell Lymphoma2024-513616-95-00Karyopharm Therapeutics Inc.60