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Belimumab + Rituximab for Systemic Sclerosis
Study Summary
This trial will test whether a combination of Belimumab & Rituximab, given on top of standard Mycophenolate Mofetil therapy, can improve fibrosis in early diffuse cutaneous systemic sclerosis (dcSSc) patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have any health conditions that would make it unsafe for me to take a new drug.I have been diagnosed with diffuse cutaneous systemic sclerosis.My condition has been diagnosed for over 3 years.I haven't taken any anti-fibrotic drugs like colchicine or tyrosine kinase inhibitors in the last month.My condition is linked to exposure to certain toxic substances.I have used Belimumab, Rituximab, or similar treatments before.I haven't had IV or IM antibiotics in the last 60 days.Your IgG level is below 400 mg/dL.I have severe lung disease requiring extra oxygen or have low lung function.I have a severe deficiency in my immune system's antibodies.I have not been hospitalized for an infection in the last 60 days.I have not used specific biologic drugs within their required washout periods.I am on medication for a long-term infection like TB or herpes.I have had or currently have Hepatitis B.You have had a severe allergic reaction to certain medications given by injection.I am not pregnant and will use birth control during the study.I do not have any severe health conditions that would make me unsuitable for this study.My first non-Raynaud's symptom appeared less than 3 years ago.I have been diagnosed with limited scleroderma.You have struggled with drug or alcohol abuse in the past year.I am between 18 and 80 years old.I have not received any live vaccines in the last 30 days.Your neutrophil count is less than 1.5X10E9/L.Your skin score is higher than 14.You have very low levels of IgA in your body.You have tested positive for HIV in the past or test positive for HIV during the screening.I am unable to understand or sign the consent form.I haven't had a serious infection or been on strong antibiotics recently.You have shown serious signs of wanting to harm yourself, such as attempting suicide in the past 6 months or thinking about it in the past 2 months.I haven't had cancer in the last 5 years, except for certain skin cancers or early cervical cancer.You have a positive test for Hepatitis C antibody.You have any other important abnormal test results, according to the doctor.I have not taken more than 10 mg of prednisone daily in the last month.My main condition is diffuse systemic sclerosis, not mixed connective tissue disease.My condition is officially diagnosed as systemic sclerosis.You have a history of a weak immune system from birth.
- Group 1: MMF + Rituximab + Belimumab
- Group 2: MMF + Placebo + Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment still available for this clinical trial?
"Indeed, clinicaltrials.gov attests to this trial's active recruitment status. This medical experiment was initially posted on July 29th 2019 and subsequently revised on September 8th 2022. A total of 30 patients are needed across a single site for the completion of this research effort."
Does this research endeavor include participants above the age of twenty?
"This medical trial is accepting individuals who are of legal age and not older than 80 years old."
Has the FDA issued a sanction for Rituximab's utilization?
"Due to the fact that Rituximab is in its second stage of clinical trials, our team has allocated a score of 2 which denotes some data backing safety yet no proof for efficacy."
What objectives are researchers hoping to fulfill through this experiment?
"This 12 month clinical trial will measure the proportion of participants who experience at least one Grade 3 or higher adverse event. Additionally, it will consider injection site reactions, infusion reactions, and any untoward medical occurrences that occur in a patient while using the medication as part of this experiment."
Could you enumerate other experiments conducted using Rituximab?
"Presently, 535 research projects on Rituximab are underway with 105 trials in the final phase. Philadelphia pa is the epicentre of many of these studies but other sites across 14931 locations are actively conducting investigations into Rituximab."
Is it feasible for me to participate in this experiment?
"In order to meet the criteria for entry into this trial, individuals must be between 18 and 80 years of age with a diagnosis of scleroderma diffuse. So far, 30 participants have been accepted."
What is the utmost number of individuals involved in this research?
"Indeed, clinicaltrials.gov attests to the ongoing recruitment of this medical trial which was initially posted on July 29th 2019 and recently updated on September 8th 2022. The study is expecting 30 patients from a single center."
What medical conditions are commonly treated through the use of Rituximab?
"Rituximab is commonly used to treat diffuse large b-cell lymphoma (DLBCL) and can also be a viable solution for other conditions, namely B-cell lymphomas, polyangiitis, rejection of organ transplantation, and liver disorders."
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