Multiple SclerosisNCT04283747
Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis
An observational study of Multiple Sclerosis and Hypogammaglobulinemia, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Hypogammaglobulinemia
- What is being tested?
- Serum immunoglobulin titer
- How many people
- 170 participants
- Where
- 1 siteIran
- Study dates
- 28 Feb 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- diagnosis of multiple sclerosis compatible with 2017 McDonald criteria
- history of treatment with ritximab at least for 18 month
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Bu Ali Sina hospital
Sari
athena sharifi razavi
About this study
Official title: Hypogammaglobulinemia and Immunization Responses to Measles in Rituximab-treated Multiple Sclerosis Patients
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Hypogammaglobulinemia
- Being tested
- Serum immunoglobulin titer
- Keywords
- Rituximab, Varicella Zoster, Hypogammaglobulinemia
- Medical subject headings
- Multiple Sclerosis, Agammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum immunoglobulin titerDiagnostic test
Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hypogammaglobinemia
serum IgG concentration lower than g/L,
Measured: every 6 month until 18 month
Secondary outcomes (5)
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
Measured: every 6 month until 18 month
immunization response to VZV vaccination
change of VZV antibody titre
Measured: every 6 month until 18 month
Rate of infection
number of all infection events
Measured: during 18 month of fallow up
type of infection
infections in different organs
Measured: During 18 month of study
severity of infection events
need for hospitalization, oral or intravenous antibiotic therapy
Measured: During 18 month of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start28 Feb 2020
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athena Sharifi Razavi, Mazandaran University of Medical Sciences
- Investigators
- monireh ghazaeian, Study director, mazandaran university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283747
- Sponsor's protocol ID
- 6217
- Status last verified
- Jul 2020
- First submitted
- 22 Feb 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD will be shared with other researchers if asked
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypogammaglobulinemia and Immunization Responses to Measles in Rituximab-treated Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04283747
- Acronym / sponsor ID
- 6217
- Conditions
- Multiple Sclerosis, Hypogammaglobulinemia
- Keywords
- Rituximab, Varicella Zoster, Hypogammaglobulinemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- diagnosis of multiple sclerosis compatible with 2017 McDonald criteria
- history of treatment with ritximab at least for 18 month
- written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum immunoglobulin titerSerum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times | Diagnostic test | – |
Primary outcome
Rate of hypogammaglobinemia
Time frame: every 6 month until 18 month
serum IgG concentration lower than g/L,
5 secondary outcomes
severity of hypogammaglobinemia
Time frame: every 6 month until 18 month
immunization response to VZV vaccination
Time frame: every 6 month until 18 month
Rate of infection
Time frame: during 18 month of fallow up
type of infection
Time frame: During 18 month of study
severity of infection events
Time frame: During 18 month of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers if asked
Related trials for Multiple Sclerosis
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Recruiting
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
monireh ghazaeian study director
mazandaran university of medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Hypogammaglobulinemia, run by Mazandaran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athena Sharifi Razavi (00989113510136, athena.sharifi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hypogammaglobinemia (time frame: every 6 month until 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.