BElimumab corticoSteroids Sparing Treatment in Systemic L... | NCT05624437

Studies
BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus

NCT05624437

Sponsor

Centre Hospitalier de Niort

Status

Completed

Last Update Posted

Nov 22, 2022Actual

Enrollment

33Actual

Phase

Not provided

Conditions

SLE (Systemic Lupus)

Interventions

data record

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2021Actual

Primary Completion Date

Nov 19, 2021Actual

Completion Date

Aug 31, 2022Actual

First Submitted Date

Nov 29, 2021

First Submission Date that Met QC Criteria

Nov 17, 2022

First Posted Date

Nov 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2022

Last Update Posted Date

Nov 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

BELIMUMAB, anti-BLyS human monoclonal antibody, is the first immunotherapy used for the treatment of systemic lupus erythematosus (SLE) which was licensed in 2011 in France.

Currently, Belimumab is reimbursed for the treatment of active SLEwith autoantibody-positive after intolerant or initial failure of first-line traitment (anti malaria, non-steroidal anti-inflammatory drugs, glucocorticoids and/ou immunomodulatory agents).

EUropean League Against Rheumatism (EULAR) suggest the following terminology of "low dose" when steroids are less than 7.5 mg/day (prednisone equivalent) because this dose range is often used for maintenance therapy for many rheumatic diseases requiring glucocorticoids and it is relatively few adverse effects.

In patients with SLE, a significant proportion of the damage could be attributed to corticosteroid therapy, and this damage accumulated over time.

Thanks to randomised and subgroups trials, post-hoc analysis , BELIMUMAB seems to be interesting in the maintain of lowest possible dose of glucocorticoids. However, these studies were not design with this aim, so it is impossible to conclude.

Thus, BELIMUMAB seems to be very interesting treatment to redcuce glucocorticoids level.

We conduce a multicentric French study in real-life settings, to assess the ability of belimumab to achieve low-dose of steroids.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Name	Type	Description	Arm Group Labels	Other Names
data record	Other	data record

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients whith low dose of steroids at six months after BELIMUMAB	number of patients whith low dose of steroids at six months after BELIMUMAB	at six months after BELIMUMAB

Secondary Outcomes

Measure	Description	Time Frame
number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB	12, 18 and 24 months after BELIMUMAB
cumulative dose of steroids at 6, 12, 18, 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

person aged ≥ 18 years
with SLE according to ACR/EULAR criteria 2019
started treatment by BELIMUMAB between 13 / July / 2011 to 13 / July / 2020
following in an hospital center in Poitiers, La Rochelle, Rochefort, Niort, Angoulême, Nantes, Rennes, Tours, Angers
affiliate or beneficiary of a social security scheme

Exclusion Criteria:

Persons Under guardianship or curatorship or without civil law
Pregnant and breastfeeding
Persons who refused to participate
Patients who stoppped BELIMUMAB before 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

person aged ≥ 18 years

with SLE according to ACR/EULAR criteria 2019
started treatment by BELIMUMAB between 13 / July / 2011 to 13 / July / 2020
following in an hospital center in Poitiers, La Rochelle, Rochefort, Niort, Angoulême, Nantes, Rennes, Tours, Angers
affiliate or beneficiary of a social security scheme

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CH Niort		Niort		79021	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057286	Electronic Health Records

Ancestor Terms

ID	Term
D016347	Medical Records Systems, Computerized
D008499	Medical Records
D011996	Records
D003625	Data Collection

Browse Leaves

Not provided

Browse Branches

Not provided