Brentuximab Vedotin for Systemic Sclerosis
Study Summary
This trial is testing a drug, brentuximab vedotin, to see if it is safe and effective for treating Diffuse Cutaneous Systemic Sclerosis (dcSSc), a disease with few treatment options.
- Systemic Sclerosis
- Scleroderma
- Diffuse Cutaneous Systemic Sclerosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 6 Secondary · Reporting Duration: From week 0 (≥first dose of assigned treatment) to week 12, week 24, week 36, and week 48 post-randomization
Trial Safety
Safety Progress
Side Effects for
Trial Design
6 Treatment Groups
Cohort 1: 0.6 mg/kg brentuximab vedotin
1 of 6
Cohort 2: 1.2 mg/kg brentuximab vedotin
1 of 6
Cohort 3: 1.8 mg/kg brentuximab vedotin
1 of 6
Cohort 2: placebo
1 of 6
Cohort 3: placebo
1 of 6
Cohort 1: placebo
1 of 6
Experimental Treatment
Non-Treatment Group
17 Total Participants · 6 Treatment Groups
Primary Treatment: Brentuximab Vedotin · Has Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
California | 100.0% |
How old are they?
18 - 65 | 100.0% |
What site did they apply to?
UCLA Medical Center: Division of Rheumatology | 100.0% |
What portion of applicants met pre-screening criteria?
Met criteria | 100.0% |
Frequently Asked Questions
Are there any opportunities to enroll in this clinical experiment at the moment?
"According to the records found on clinicaltrials.gov, this research endeavour is currently accepting participants. The trial was first uploaded on September 20th 2017 and its details were last modified on May 12th 2022." - Anonymous Online Contributor
In how many different locations can patients access this experiment?
"The University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology in Ann Arbor, the Medical University of South Carolina: Division of Rheumatology & Immunology in Charleston and Georgetown University Medical Center: Division od Rheumatology located in Washington D.C are only some out 8 other medical facilities associated with this clinical trial." - Anonymous Online Contributor
Is this research endeavor open to seniors aged 65 or above?
"According to the prerequisites for this clinical experiment, participants must be aged 18 or above and no older than 70." - Anonymous Online Contributor
Is it possible to partake in this clinical experiment?
"This trial seeks to enrol 24 patients suffering from scleroderma, aged 18-70. Necessary requirements include a 2013 American College of Rheumatology/European Union League Against Rheumatism classification for systemic sclerosis; LeRoy and Medsger criteria for the diagnosis of diffuse cutaneous systemic sclerosis; disease duration not exceeding 60 months, mild or moderate skin thickening in the forearm with minimal rash severity score system rating (mRSS); Methotrexate dosage limited to 25 mg per week, Mycophenolate mofetil consumed at 3 grams daily or mycophenolate sodium no greater than 2." - Anonymous Online Contributor
For what therapeutic purpose is Brentuximab Vedotin typically deployed?
"Brentuximab Vedotin has the potential to help treat various forms of cancer, such as Hodgkin Disease and Systemic Anaplastic Large Cell Lymphoma. It may also be employed for those suffering from previously untreated Peripheral T-Cell Lymphoma." - Anonymous Online Contributor
Is this medical experiment pioneering in its field?
"Since 2011, Seagen Inc. has been researching Brentuximab Vedotin with the earliest study involving 79 patients. This led to Phase 2 approval in the same year. Currently, there are 59 ongoing studies on this medication occurring across 630 towns and cities within 31 nations." - Anonymous Online Contributor
What precedent is there for the use of Brentuximab Vedotin in clinical research?
"Currently, 59 studies involving Brentuximab Vedotin are ongoing. 6 of these trials are in the late-stage phase 3 testing category. The majority of research is based out of Montvale, New Jersey; however there exists 1851 separate sites conducting this clinical trial at present." - Anonymous Online Contributor
What is the current enrollment count for this clinical research project?
"To operate the trial, 24 qualified individuals are required. The sponsor - PPD - is administrating this medical experiment from two locations: University of Michigan Health System's Department of Internal Medicine Division of Rheumatology in Ann Arbor and Medical University of South Carolina's Division of Rheumatology & Immunology in Charleston." - Anonymous Online Contributor