Rituximab-Induced Hypogammaglobulinemia in Multiple Scler... | NCT04283747

Studies
Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

NCT04283747

Sponsor

Mazandaran University of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 10, 2020Actual

Enrollment

170Estimated

Phase

Not provided

Conditions

Multiple Sclerosis
Hypogammaglobulinemia

Interventions

Serum immunoglobulin titer

Countries

Iran

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

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2020Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Feb 22, 2020

First Submission Date that Met QC Criteria

Feb 22, 2020

First Posted Date

Feb 25, 2020Actual

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

Jul 8, 2020

Last Update Posted Date

Jul 10, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Athena Sharifi Razavi, Assistant Professor in Nerology, Mazandaran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mazandaran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab is being increasingly utilized as an off-label treatment option across MS patients .

In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including MS and related neuroinflammatory disorders.

Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated MS adult patients and to assess the correlation with vaccination response during the treatment.

Detailed Description

This is a prospective study which will be conducted in an educational medical hospitals in Sari, Iran.Adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and history of treatment with rituximab at least 3 times( 18 month) , enrolled to this study.Demographic patients' characteristics, including age, sex, vital sign, past medical history, drug history, will be recorded. Disease duration prior to rituximab, total rituximab dose, prior immunomodulatory drugs, Adverse drug reactions, the time interval between the last rituximab infusion and need for intravenous immunoglobulin replacement therapy and infections are recorded. Moreover, we will assess IgG and IgM levels, VZV titer at before rituximab administration and 6, 12, 18, months following the initiation of next dose of rituximab.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum immunoglobulin titer	Diagnostic Test	Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of hypogammaglobinemia	serum IgG concentration lower than g/L,	every 6 month until 18 month

Secondary Outcomes

Measure	Description	Time Frame
severity of hypogammaglobinemia	serum IgG concentration: mild (at risk) 5- 6.9 g/L, moderate 3- 4.9 g/L and severe < 3 g/L	every 6 month until 18 month
immunization response to VZV vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of multiple sclerosis compatible with 2017 McDonald criteria
history of treatment with ritximab at least for 18 month
written informed consent

Exclusion Criteria:

history of IVIG intake in 3 past month
history of plasmapheresis in 3 past month
unknown vaccination history
any indication for concurrent use of immunomodulator or immunosuppressor drug

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

Any adult patients with diagnosis of multiple sclerosis compatible with 2017 McDonald criteria and meet the inclusion and exclusion criteria from January 2020 until sample size will be reach, that refer to MS clinic of Bu Ali Sina Hospital, Sari,Iran.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Athena Sharifi Razavi	Contact	00989113510136		athena.sharifi@yahoo.com

Overall Officials

Name	Affiliation	Role
monireh ghazaeian	mazandaran university of medical science	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bu Ali Sina hospital	Recruiting	Sari			Iran

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD will be shared with other researchers if asked

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D000361	Agammaglobulinemia

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided