Meta AnalysisID 1817
关于鞘氨醇-1-磷酸受体调节剂（阿米塞利莫德、奥扎莫德、珀奈莫德、西尼莫德）有效性和安全性的随机临床试验（安慰剂对照或阳性对照）系统评价和Meta分析方案
CRD42020199697
1. Does the sphingosine-1-phosphate (SIP) receptor modulators (amiselimod, ozanimod, ponesimod, siponimod) prove non-inferiority or superiority over placebo or comparators in subjects with any type/stage of multiple scle
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 1817
- Evidence Id
- 10375
- Core Evidence Id
- 10375
- Source Meta Analysis Id
- 1762
- Herb2 Meta Analysis Id
- HBMA001762
- Crd Id
- CRD42020199697
- Title
- Protocol for systematic review and meta-analysis on Randomized clinical trials (placebo-controlled or comparator) on the efficacy and safety of sphingosine-1-phosphotase receptor modulators (amiselimod, ozanimod, ponesimod, siponimod)
- Review Question
- 1. Does the sphingosine-1-phosphate (SIP) receptor modulators (amiselimod, ozanimod, ponesimod, siponimod) prove non-inferiority or superiority over placebo or comparators in subjects with any type/stage of multiple sclerosis (MS)? 2. Does the phingosine-1-phosphate receptor modulator prove a safety profile as compared to other drug classes used in MS? 3. Is there any differences aligned between the members (amiselimod, ozanimod, ponesimod, siponimod) of the class (SIP).
- Study Type Included
- Randomized clinical trials (placebo-controlled or comparator)
- Condition Being Studied
- Subjects with any type/stage or multiple sclerosis; adult; using sphingosine-1-phosphate receptor modulator versus comparator; placebo in the randomized clinical trial
- Participant
- adult; both gender, MS, intervention, comparator; placebo; randomized clinical trial, using sphingosine-1-phosphate receptor modulator (Subjects receiving one of the following interventions: amiselimod, ozanimod, ponesimod, siponimod.) versus comparator
- Animal
- Human Disease Modelled
- Intervention
- sphingosine-1-phosphate receptor modulator (amiselimod, ozanimod, ponesimod, siponimod)
- Comparator Control
- placebo or any other drug used in MS other than (aniselimod, ozanimod, ponesimod, siponimod)
- Main Outcome
- Types of outcome measures Primary outcome measure improvement in any of the folloing: 1. SPMS 2. Walk 3. Disability 2. or the composite of any of the above. 3. time to 3-month complete disability progress (CDP) 4. percentage reduction in the monthly number of combined unique active lesions at 3 months In summary, the primary outcome measure will be the clinical improvement in the clinical improvement in disability and prognosis at the end of treatment in the ITT population (outcomes). The differences in treatment (effect size) between the intervention drug (S1P) and placebo/comparators as non-inferiority or superiority will be reported. Measures of effect number in intent-to-treat NITT The measures of effect will be the reduction on the disease markers and/or improvement of disability. The magnitude of difference between S1P and the placebo or the comparator will be of high priority.
- Outcome Measure
- Additional Outcome
- Safety assessments included: 1. reporting of adverse events 2. regular monitoring of the physical condition 3. vital signs, optical coherence tomography electrocardiographic, 4. Holter monitoring for cardiac adverse events 5. monitoring of clinical laboratory parameters Measures of effect The measures of effect will be the reduction on the disease markers and/or improvement of disability. The magnitude of difference between S1P and the placebo or the comparator will be of high priority.
- Study Method
- Intervention, Meta-analysis, Systematic review
- Keyword
- Humans; Meta-Analysis as Topic; Randomized Controlled Trials as Topic; Sphingosine; Systematic Reviews as Topic; amiselimod; ozanimod; ponesimod; siponimod
- Contact
- Asim Elnour [email protected]
- Organisational Affiliation
- Al Ain University
- Funding Source
- None Grant number(s) <span style=font-size: 14px>State the funder, grant or award number and the date of award</span> None
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- United Arab Emirates
- Review Stage
- Review Ongoing
- First Submission Date
- 2020-08-14
- Registration Date
- 2020-09-13
- Anticipated Start Date
- 2020-07-15
- Anticipated Completion Date
- 2020-09-30
- Title Cn
- 关于鞘氨醇-1-磷酸受体调节剂（阿米塞利莫德、奥扎莫德、珀奈莫德、西尼莫德）有效性和安全性的随机临床试验（安慰剂对照或阳性对照）系统评价和Meta分析方案
- Title En
- Protocol for systematic review and meta-analysis on Randomized clinical trials (placebo-controlled or comparator) on the efficacy and safety of sphingosine-1-phosphotase receptor modulators (amiselimod, ozanimod, ponesimod, siponimod)
- Bilingual Status
- complete