Autoimmune DiseasesEXPRIMENCT03778840
Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab
An observational study of Autoimmune Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2019to 31 May 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: The patients included in the study will be the patients beginning a cure of RTX prescribed within the framework of the treatment of their inflammatory disease or dysimmunitaire chronic.
Who may be able to join
- Patient initiating treatment with RTX, delivered by the central pharmacy of Lille University Hospital
- Inpatient or outpatient at Lille University Hospital (in one of the following departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and monitored every three months as part of routine care (as part of the surveillance of induction of RTX treatment)
- Patient with one of the following autoimmune diseases, defined by international criteria
Who cannot join
- Treatment with rituximab for a malignancy or a transplant reject
- Pregnant or lactating women
- People in emergency
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
- Persons deprived of their liberty
- People unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.
The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.
- Conditions
- Autoimmune Diseases
- Keywords
- Infections, immunoglobulins, secondary immunodeficiency, rituximab
- Medical subject headings
- Autoimmune Diseases, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab
A serious infection event [SIE] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs
Measured: Within 12 months after inclusion
Secondary outcomes (3)
Hypogammaglobulinemia
defined by immunoglobulin (Ig) G <6g / L.
Measured: Within 12 months after inclusion
Replacement therapy with immunoglobulins
Start of an immunoglobulins therapy to replace gammaglobulins
Measured: Within 12 months after inclusion
Hypersensitivity skin reaction secondary to RTX injection.
Attack rate of cutaneous hypersensitivity reactions after RTX injection in patients with dysimmune disease.
Measured: Within 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start29 May 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Sponsor
- Investigators
- Vincent SOBANSKI, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778840
- Sponsor's protocol ID
- 2018_06
- Other IDs
- 2018-A00188-47
- Acronym
- EXPRIME
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2018
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab
- ClinicalTrials.gov ID
- NCT03778840
- Acronym / sponsor ID
- EXPRIME / 2018_06
- Conditions
- Autoimmune Diseases
- Keywords
- Infections, immunoglobulins, secondary immunodeficiency, rituximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- 29 May 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Dec 2018 (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.
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.
The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.
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
- The patients included in the study will be the patients beginning a cure of RTX prescribed within the framework of the treatment of their inflammatory disease or dysimmunitaire chronic.
Key inclusion criteria (3 listed)
- Patient initiating treatment with RTX, delivered by the central pharmacy of Lille University Hospital
- Inpatient or outpatient at Lille University Hospital (in one of the following departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and monitored every three months as part of routine care (as part of the surveillance of induction of RTX treatment)
- Patient with one of the following autoimmune diseases, defined by international criteria
Key exclusion criteria (6 listed)
- Treatment with rituximab for a malignancy or a transplant reject
- Pregnant or lactating women
- People in emergency
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
- Persons deprived of their liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab
Time frame: Within 12 months after inclusion
A serious infection event [SIE] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs
3 secondary outcomes
Hypogammaglobulinemia
Time frame: Within 12 months after inclusion
Replacement therapy with immunoglobulins
Time frame: Within 12 months after inclusion
Hypersensitivity skin reaction secondary to RTX injection.
Time frame: Within 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
Vincent SOBANSKI, MD, PhD principal investigator
University Hospital, Lille
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 Autoimmune Diseases, run by University Hospital, Lille at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 7 Apr 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab (time frame: Within 12 months after inclusion). 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 7 Apr 2026.