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Upadacitinib for Lupus (SELECT-SLE Trial)
SELECT-SLE Trial Summary
This trial will assess if upadacitinib is a safe and effective treatment for SLE. 500 people will take part in this trial globally, taking either upadacitinib or a placebo in 3 sub-studies. Regular visits & assessments to check the effect of the treatment will be done.
SELECT-SLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSELECT-SLE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 613 Patients • NCT03086343SELECT-SLE Trial Design
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Who is running the clinical trial?
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- I was diagnosed with lupus more than 24 weeks ago.My lupus is active with a score of 6 or more, mainly from symptoms, not lab tests.I've been on the same treatment for at least 30 days, except for oral steroids which I've had at a stable dose for 14 days.I am taking no more than one of the specified medications at or below the listed doses.I have tested positive for anti-dsDNA.I am taking 20 mg or less of prednisone daily.I have tested positive for anti-Smith antibodies.I am taking antimalarial medication within the specified daily limits.
- Group 1: Study 3- Open Label Upadacitinib Dose B
- Group 2: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
- Group 3: Study 1- Placebo
- Group 4: Study 3- Open Label Upadacitinib Dose A
- Group 5: Study 3- Low Disease Activity Upadacitinib Dose B
- Group 6: Study 2- Upadacitinib Dose A
- Group 7: Study 3- Upadacitininb Dose A
- Group 8: Study 2- Placebo
- Group 9: Study 3- No LDA Upadacitinib Dose A
- Group 10: Study 1- Upadacitinib Dose A
- 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
What potential harms could be associated with taking the Upadacitinib Dose A of Study 1?
"Our team has assigned a rating of 3 to Study 1- Upadacitinib Dose A as there is existing evidence for its efficacy and multiple trials have corroborated the medication's safety."
Are additional participants being accepted for this trial?
"According to clinicaltrials.gov, this particular trial is not presently enrolling new patients. Although it was first published on June 30th 2023 and most recently updated April 25th of the same year, there are 142 alternative trials at the moment looking for participants."
Do those who are fifty or over qualify to participate in this clinical trial?
"The entry requirements for this particular trial are restricted to individuals aged 18-63. Separately, there are 22 trials that cater specifically to minors and 122 tailored towards seniors."
How many venues are hosting this investigation?
"This trial has already enrolled 258 patients, such as those at UF Health Rheumatology (ID# 255351) in Jacksonville, Lakes Research LLC (ID# 253621) in Miami, and HMD Research LLC (ID# 253595) in Orlando."
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What portion of applicants met pre-screening criteria?
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