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Belimumab for Early Lupus
Study Summary
This trial will study the effects of the drug belimumab on patients with early lupus. Half the patients will receive the drug, while the other half will receive a placebo. The trial will last two years.
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.Side effects data
From 2017 Phase 3 trial • 106 Patients • NCT01663623Trial Design
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Who is running the clinical trial?
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- I have taken drugs like azathioprine or cyclophosphamide before.I have been treated with medications like rituximab or belimumab for lupus.I agree to use birth control during and for 4 months after treatment.I have been diagnosed with lupus according to ACR criteria.I have a history of serious, recurring infections.I have not received a live vaccine in the last 30 days or while on belimumab.I do not have any health conditions that would make it unsafe for me to take a new drug.I do not have active kidney or nervous system disease.I have not taken high doses of steroids in the last 4 weeks.My kidney function is low, with a creatinine clearance of 25ml/min or less.I am on medication for a long-term infection like TB or herpes.My methotrexate dose has been the same for the last 4 weeks.I am taking hydroxychloroquine or cannot tolerate it.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.My daily corticosteroid dose has been stable and ≤ 30mg for the last 4 weeks.I haven't had IV or IM antibiotics in the last 60 days.I do not have serious heart or lung conditions.I have tested positive for anti-ds DNA antibodies.My ANA test result is positive with a high level.I was hospitalized for an infection within the last 60 days.My doctor expects I'll need a new cancer drug within a year.I've needed steroids twice or more in the last year for my health conditions.I was diagnosed with lupus less than 2 years ago.
- Group 1: Belimumab
- Group 2: Belimumab/Placebo
- Group 3: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any opportunities to enroll in this exploration?
"Affirmative. The information on clinicaltrials.gov shows that recruitment is still ongoing for this medical trial, which was initially published on September 15th 2020 and modified most recently in December 2nd 2021. This research seeks to include 30 patients at a single site."
Has a comparable medical trial been conducted before this one?
"Currently, 17 trials for Belimumab/Placebo are taking place in 15 countries and 36 cities. Originally sponsored by Human Genome Sciences Inc., a GSK Company, the first trial launched in 2012 with 93 participants and successfully completed Phase 2 drug approval. Since then, 18359 studies have been conducted on the subject."
Have any other research initiatives compared Belimumab to a placebo?
"At present, 17 studies assessing the effects of Belimumab/Placebo are ongoing with two in Phase 3. These clinical trials are being conducted at 88 different sites across Beijing and beyond."
What is the aggregate size of the participants in this research project?
"Confirmed. Information posted on clinicaltrials.gov affirms that this research endeavour is still actively seeking participants, which was initially launched on September 15th 2020 and most recently updated December 2nd 2021. A total of 30 people are required to be recruited from a single medical centre."
What potential risks exist with Belimumab/Placebo use?
"The safety of Belimumab/Placebo has been assessed as a 3 on the 1 to 3 scale, indicating that it is an approved treatment due to its Phase 4 clinical trial status."
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