Diffuse Cutaneous Systemic Sclerosis study: Extracorporeal Photopheresis vs UVADEX
Official title Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis
ClinicalTrials.gov ID: NCT04986605
What this study is testing
What is UVADEX?
An investigational drug being studied as a potential treatment for diffuse cutaneous systemic sclerosis. It is designed to bind DNA and, when activated by UVA light during extracorporeal photopheresis, modify immune cells.
Also referred to as 8-mop, methoxsalen.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether extracorporeal photopheresis is safe and shows early signs of working for diffuse cutaneous systemic sclerosis.
- Who it's for
- You may be able to join if you have active diffuse cutaneous systemic sclerosis.
- What's involved
- You will have blood drawn, the blood will be treated with a special light, and then returned to you. You will visit the clinic for the procedure and for safety checks.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet the ACR/EULAR classification criteria for SSc (2013).
- Early dcSSc (within 5 years of first non-Raynaud's phenomenon symptom) or any other dcSSc patients who have at least one of the signs of disease...
- Able to give informed consent.
You likely can't join if
- Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
- Class IV PAH or PH.
- Clinically significant cardiac disease.
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, cardiac, hepatic, pancreatic, hematological...
- Chronic or ongoing active infectious disease requiring systemic treatment, including active tuberculosis (TB) infection.
- Seropositivity for human immunodeficiency virus (HIV) at study entry.
See the full eligibility criteria
- people must meet the ACR/EULAR classification criteria for SSc (2013).
- Early dcSSc (within 5 years of first non-Raynaud's phenomenon symptom) or any other dcSSc patients who have at least one of the signs of disease activity: mRSS of 15 or more, presence of tendon friction rubs, elevated...
- Able to give informed consent.
- Poor pulmonary function (FVC\<40% and/or DLCO\<30%).
- Class IV PAH or PH.
- Clinically significant cardiac disease.
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, cardiac, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric...
- Chronic or ongoing active infectious disease requiring systemic treatment, including active tuberculosis (TB) infection.
- Seropositivity for human immunodeficiency virus (HIV) at study entry.
- Active viral infection with viral replication of hepatitis B or C virus at study entry.
- Thrombophilia.
- Contraindications to heparin including history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITTS), history of thrombocytopenia with pentosan polysulfate, known...
- Low Platelet count (less than 100,000 per mm3).
- Aphakia (absence or loss of the eye's lens and has not been replaced with an artificial lens), because of the significantly increased risk of retinal damage due to the absence of lenses.
- Severe anemia (hemoglobin \<70g/L).
- High white blood cell count (greater than 25000 mm3).
- A history of surgical spleen removal.
- A history of a light sensitive disease state, i.e. lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism.
- Previous idiosyncratic reactions to psoralen compounds.
- Patients who are using photosensitizing drugs such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides...
- Treatment with more than 2 immunosuppressants (including mofetil mycophenolate, methotrexate, cyclophosphamide, biologics) at study entry.
- Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
- Participation in another clinical trial within six weeks before randomization in this study.
- Previous use of Extracorporeal photopheresis.
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.