BridgeMD
Tests treatment safety and results for Rheumatoid Arthritis (RA) and Sjögren's Disease (SjD)
Official title A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of Rapcabtagene Autoleucel in Rheumatoid Arthritis and Sjogren's Disease
ClinicalTrials.gov ID: NCT07048197
What this study is testing
What is Rapcabtagene autoleucel?
Rapcabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rheumatoid arthritis (ra) and sjögren's disease (sjd).
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
- A study to assess safety, cellular kinetics and exploratory efficacy of rapcabtagene autoleucel in rheumatoid arthritis and Sjogren's disease
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study
- Men and women aged ≥ 18 years and ≤ 75 years at Screening For RA only
- Diagnosis of rheumatoid arthritis
- Treatment failure of standard of care therapies
- Active disease For SjD only
You likely can't join if
- BMI at Screening of ≤17 or ≥ 40 kg/m2
- Clinically significant active, opportunistic, chronic or recurrent infection
- Sexually active males unwilling to use a condom during intercourse from the time enrollment
- Women of childbearing potential, unless they are using a highly effective method of contraception starting from the time of enrollment
- Female participants who are pregnant, breastfeeding or intending to conceive during the course of the study
- Inadequate organ function during screening
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study
- Men and women aged ≥ 18 years and ≤ 75 years at Screening For RA only
- Diagnosis of rheumatoid arthritis
- Treatment failure of standard of care therapies
- Active disease For SjD only
- Diagnosis of Sjogren's disease
- Active disease
- BMI at Screening of ≤17 or ≥ 40 kg/m2
- Clinically significant active, opportunistic, chronic or recurrent infection
- Sexually active males unwilling to use a condom during intercourse from the time enrollment
- Women of childbearing potential, unless they are using a highly effective method of contraception starting from the time of enrollment
- Female participants who are pregnant, breastfeeding or intending to conceive during the course of the study
- Inadequate organ function during screening
- History of lymphoproliferative disease or any known malignancy or history of malignancy
- History of bone marrow/hematopoietic stem cell or solid organ transplantation
- Any psychiatric condition or disability making compliance with treatment or informed consent impossible Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Brest, France
- Le Kremlin-Bicêtre, France
- Lille, France
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Göttingen, Lower Saxony, Germany
- Cologne, North Rhine-Westphalia, Germany
- Berlin, Germany
- Ulm, Germany
- Singapore, Singapore
- Barcelona, Spain
- Madrid, Spain
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 - 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Brest, France; Le Kremlin-Bicêtre, France; Lille, France; Freiburg im Breisgau, Baden-Wurttemberg, Germany; Göttingen, Lower Saxony, Germany and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.