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
Study on Infections in Autoimmune Disease Patients on Rituximab
Plain English Summary
Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab is a Not Applicable clinical trial sponsored by University Hospital, Lille studying Autoimmune Diseases. This study observes patients with autoimmune diseases who are starting treatment with rituximab. It aims to understand the rate and causes of infections and the need for immunoglobulin replacement therapy in these patients. Participation involves routine monitoring as part of standard care. There are no alternative treatments being tested in this observational study. The trial aims to enroll 73 participants.
Official 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. 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients starting rituximab treatment at Lille University Hospital for an autoimmune disease. Patients must be treated and monitored at Lille University Hospital. Must be diagnosed with specific autoimmune diseases based on international standards. Cannot have received rituximab for cancer or transplant rejection, be pregnant or breastfeeding, or be unable to consent or participate. This trial is studying Autoimmune Diseases, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the occurrence of serious infections within 12 months, helping to identify how often patients on rituximab develop significant infections. The specific primary outcome measures are: Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab (Within 12 months after inclusion). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because rituximab, while effective for autoimmune diseases, can increase infection risk, and this study seeks to better understand and manage this risk. This research targets Autoimmune Diseases, where improved treatment options are needed.
Investor Insight
This observational study provides data on infection rates in a specific patient population, which can inform future treatment guidelines and potentially the market for supportive therapies like immuno
Is This Trial Right for Me?
Ask your doctor about the specific risks of infection with rituximab and how they will be monitored. Participation involves attending regular check-ups as you normally would for your condition and treatment. The study collects data from your routine medical care, so no extra procedures are typically required. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 73 participants
Primary Outcomes
- Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab (Within 12 months after inclusion)
Secondary Outcomes
- Hypogammaglobulinemia (Within 12 months after inclusion)
- Replacement therapy with immunoglobulins (Within 12 months after inclusion)
- Hypersensitivity skin reaction secondary to RTX injection. (Within 12 months after inclusion)
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
- Hôpital Claude Huriez, CHU, Lille, France
Frequently Asked Questions
What is clinical trial NCT03778840?
NCT03778840 is a Not Applicable OBSERVATIONAL study titled "Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab." It is currently completed and is sponsored by University Hospital, Lille. The trial targets enrollment of 73 participants.
What conditions does NCT03778840 study?
This trial investigates treatments for Autoimmune Diseases. The primary condition under study is Autoimmune Diseases.
What does Not Applicable mean for NCT03778840?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03778840?
This trial is currently "Completed." It started on 2019-05-29. The estimated completion date is 2022-05-31.
Who is sponsoring NCT03778840?
NCT03778840 is sponsored by University Hospital, Lille. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03778840?
The trial aims to enroll 73 participants. The trial status is completed.
How is NCT03778840 designed?
This is a observational study.
What are the primary outcomes being measured in NCT03778840?
The primary outcome measures are: Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab (Within 12 months after inclusion). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03778840 being conducted?
This trial is being conducted at 1 site, including Lille (France).
Where can I find official information about NCT03778840?
The official record for NCT03778840 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03778840. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03778840 testing in simple terms?
This study observes patients with autoimmune diseases who are starting treatment with rituximab. It aims to understand the rate and causes of infections and the need for immunoglobulin replacement therapy in these patients.
Why is this trial significant?
This trial is important because rituximab, while effective for autoimmune diseases, can increase infection risk, and this study seeks to better understand and manage this risk.
What are the potential risks of participating in NCT03778840?
The main risk is developing serious infections due to rituximab's effect on the immune system. Other potential side effects include low levels of antibodies (hypogammaglobulinemia) and reactions to rituximab infusions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03778840?
Ask your doctor about the specific risks of infection with rituximab and how they will be monitored. Participation involves attending regular check-ups as you normally would for your condition and treatment. The study collects data from your routine medical care, so no extra procedures are typically required. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03778840 signal from an investment perspective?
This observational study provides data on infection rates in a specific patient population, which can inform future treatment guidelines and potentially the market for supportive therapies like immuno This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves routine monitoring as part of standard care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.