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CFZ533 for Sjögren's Syndrome (TWINSS Trial)
TWINSS Trial Summary
This trial will study a new drug to see if it is safe and effective for treating Sjögren's Syndrome, as well as how the drug works in the body.
- Sjögren's Syndrome
TWINSS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTWINSS 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 2017 Phase 1 & 2 trial • 59 Patients • NCT02217410TWINSS Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
To what extent is enrollment for this trial being extended?
"Unfortunately, this clinical trial has ceased recruiting patients. The study was initially posted on October 1st 2019 and the most recent update occurred November 22nd 2022. If you are searching for additional studies, there are 1386 trials presently admitting participants with sicca syndrome and 3 active CFZ533 investigations actively seeking volunteers."
What potential harm can be caused by administering CFZ533?
"Considering the data from Phase 2 trials, CFZ533 is thought to be moderately safe which corresponds with a score of 2."
What is the primary objective of this clinical investigation?
"This clinical study will gauge its primary outcome, Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo, over a period of approximately two dozen weeks. Secondary objectives include the assessment of adverse events and serious adverse events across both cohorts, as well as an analysis of patients' responses on the Impact of Dry eye on Everyday Life (IDEEL) symptom bother module questionnaire, and change from baseline in ESSDAI scores for Cohort 2 - Efficacy Clinical Outcome Measures."
Is there a widespread presence of this investigation in North America?
"This trial is currently running at 13 sites, located in Indianapolis, Mineola and Philadelphia with other nearby locations. To reduce travel constraints, it would be prudent to select the closest site for participation."
Is this a pioneering or revolutionary trial?
"Presently, CFZ533 has 3 clinical trials running across 47 cities and 26 countries. Novartis Pharmaceuticals' very first trial of this drug began in 2019 with 273 participants; it was successful enough to reach the Phase 2 approval stage. Since then, a total of 18327 studies have been conducted on CFZ533."
Are there still opportunities for individuals to enroll in this experiment?
"At present, this trial is not accepting new participants. The details of the study were posted on October 1st 2019 and have been recently updated as of November 22nd 2022. Alternatively, 1386 trials are actively recruiting patients with sicca syndrome while 3 studies are seeking volunteers to be treated with CFZ533."
What other research endeavors have been conducted regarding CFZ533?
"Presently, three trials are ongoing for CFZ533; none of them being in the third phase. These studies are primarily based out of Boston, Massachusetts but have been extended to 150 locations nationwide."
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