UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052846 |
|---|---|
| Receipt number | R000060307 |
| Scientific Title | Usefulness of belimumab in adult patients with systemic lupus erythematosus evaluated using single indexes: a meta-analysis and systematic review. |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2024/06/07 17:02:39 |
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Basic information
Public title
Usefulness of belimumab in adult patients with systemic lupus erythematosus evaluated using single indexes: a meta-analysis and systematic review.
Acronym
Usefulness of belimumab in adult patients with systemic lupus erythematosus evaluated using single indexes: a meta-analysis and systematic review.
Scientific Title
Usefulness of belimumab in adult patients with systemic lupus erythematosus evaluated using single indexes: a meta-analysis and systematic review.
Scientific Title:Acronym
Usefulness of belimumab in adult patients with systemic lupus erythematosus evaluated using single indexes: a meta-analysis and systematic review.
Region
| Japan |
Condition
Condition
Systemic Lupus Erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying whether the effectiveness of belimumab treatment in SLE patients can be evaluated using single indexes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients who achieved a >= 4-point reduction in SLE Disease Activity Index (SLEDAI) score.
Key secondary outcomes
Number of patients whose BILAG score did not worsening, Number of patients whose PGA score did not worsening, Short Form 36 health survey (SF-36) score, and SLICC/ACR damage index (SDI), Number of adverse events.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinical studies are included if they meet the following criteria: 1) randomized controlled trial; 2) adult patients (18 years or older) diagnosed with SLE; 3) belimumab was the intervention drug (Regardless of route of administration); 4) improvement in SLE symptoms and safety were evaluated.
Key exclusion criteria
We exclude clinical studies that meet the following exclusion criteria: 1) not interventional studies; 2) non-original research articles such as reviews, case reports, letters, and research protocols; 3) no data description; 4) studies in children; 5) patients with lupus nephritis; 6) single-dose studies.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Ohno |
Organization
Meiji Pharmaceutical University
Division name
Department of Medication Use Analysis and Clinical Research
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose, Tokyo
TEL
042-495-8611
k-kato@my-pharm.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Suzuki |
Organization
Meiji Pharmaceutical University
Division name
Department of Medication Use Analysis and Clinical Research
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose, Tokyo
TEL
042-495-8611
Homepage URL
y-suzuki@my-pharm.ac.jp
Sponsor or person
Institute
Meiji Pharmaceutical University
Institute
Department
Personal name
Chisato Yoshijima
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable.
Address
Not applicable.
Tel
-
-
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0011393X24000080?via%3Dihub
Number of participants that the trial has enrolled
8197
Results
Patients treated with belimumab were significantly in favor of achieving more than 4-point reduction in SLEDAI score compared with patients receiving placebo.
Results date posted
| 2024 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 18 | Day |
Baseline Characteristics
adult patients (18 years or older) diagnosed with SLE
Participant flow
Adverse events
Adverse Events (AEs), SAEs, withdrawals due to AEs, and infections were not significantly different between belimumab and placebo.
Outcome measures
Number of patients who achieved a >= 4-point reduction in SLE Disease Activity Index (SLEDAI) score, Number of patients whose BILAG score did not worsening, Number of patients whose PGA score did not worsening, Short Form 36 health survey (SF-36) score, and SLICC/ACR damage index (SDI), Number of adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
completed
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060307
