Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab (NCT03778840) | Clinical Trial Compass
CompletedNot Applicable
Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab
France73 participantsStarted 2019-05-29
Plain-language 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
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study was specifically tracking serious infection events in autoimmune disease patients treated with rituximab, what did the findings show about the infection risks I might face if rituximab is part of my treatment plan?
2This trial has already been completed — is there published data from it that you've reviewed, and does it change how you'd monitor me for infections if I were to take rituximab?
3Given that this study focused on autoimmune disease patients broadly, does the infection risk data apply to my specific autoimmune condition, or is my situation different enough that the findings might not directly translate?
4If serious infections were a measurable concern worth studying in rituximab patients, what warning signs of infection should I watch for, and how quickly should I contact you if something comes up?
5Are there alternative treatments for my condition that carry a lower infection risk than rituximab, and how do you weigh that tradeoff given what studies like this one have found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab