Dendritic cells therapy combined with immunomodulatory treatment in multiple sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- EFFICACY - Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). A CUA lesion is defined as a new or persisting gadolinium-enhancing (Gd+) lesion on T1 MRI or a new or enlarging lesion on T2. Lesions identified in both scans were only counted once.
研究概览
简要总结
To evaluate the radiological efficacy and safety of TolDec therapy in combination with first line immunotherapy in RRMS patients.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age between 18-65 years old.
- •Patients diagnosed with RRMS according to 2017 McDonald criteria (see Appendix 1).
- •MS disease duration < 10 years.
- •Expanded disability status scale (EDSS) from 0 to < 5.
- •Patients eligible to start or already are in on treatment with first line immunomodulatory treatment (interferon beta 1a, interferon beta 1b, glatiramer acetate, teriflunomide or dymethyl-fumarate).
- •One or more documented relapses within the 2 years before the screening with either: a) one relapse which occurred within the last year prior the screening of the study; b) the presence of ≥ 1Gd+ T1 lesion or ≥ 2 new T2 lesion within 12 months prior the screening of the study (i.e, compared with an cerebral MRI in the last 12 months).
- •Able to sign informed consent.
- •Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogenonly hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.
排除标准
- •Presence of a relapse or use of steroids 30 days prior to screening visit.
- •Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at screening.
- •Ongoing known bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests at screening.
- •Patients with a known history of syphilis or tuberculosis or test positive for syphilis (positive rapid plasma reagin, RPR) or tuberculosis (positive skin test) at screening. Active or latent tuberculosis (TB).
- •Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol.
- •Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study.
- •Participation in other experimental studies within the previous 90 days prior to screening visit.
- •Concomitant use of any type of immunomodulatory / immunosuppressive therapy.
- •Use of previous immunosuppressive or cytotoxic therapy in the last 6 months. Use of previous alemtuzumab, cladribine or bone marrow or stem cell transplant at any time.
- •Patients unable or unwilling to undergo MRI scans.
- •Severe systemic diseases or history of cancer or hereditary familiar cancer.
- •Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease.
- •Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access).
- •Pregnant or breastfeeding women.
- •Drug or alcohol abuse.
结局指标
主要结局
EFFICACY - Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). A CUA lesion is defined as a new or persisting gadolinium-enhancing (Gd+) lesion on T1 MRI or a new or enlarging lesion on T2. Lesions identified in both scans were only counted once.
EFFICACY - Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). A CUA lesion is defined as a new or persisting gadolinium-enhancing (Gd+) lesion on T1 MRI or a new or enlarging lesion on T2. Lesions identified in both scans were only counted once.
SAFETY: - Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period. - Proportion of patients with any Grade 3 -4 adverse events related to study product.
SAFETY: - Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period. - Proportion of patients with any Grade 3 -4 adverse events related to study product.
次要结局
未报告次要终点
研究者
Dra. Yolanda Blanco
Scientific
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer