Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients
Spain53 participantsStarted 2011-03
Plain-language summary
Phase Ib/IIa clinical trial of a new medicinal product of the somatic cell therapy class (eASCs). This study is designed as a multicenter, single blind, fixed dose escalation, with three treatment groups, controlled with placebo (randomization 3:1) whose target population are patients with rheumatoid arthritis refractory to at least two biologic.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures.
. Subjects with RA under treatment with at least one non-biologic-DMARD and failure to treatment with at least two biologics.
. Of either gender, aged ≥ 18 years at time of consent.
. Able to adhere to the study visit schedule and other protocol requirements.
. Have a diagnosis of RA for ≥6 months.
. EULAR DAS28-ESR activity criteria \>3.2.
. Four tender joints to palpation and four swollen joints, based on a 68/66-joint count.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse Events and Severe Adverse Events
Timeframe: 6 months follow up after the first administration
. Treatment with biologics within the following period prior to the start of treatment:
. Infliximab: 8 weeks
. Etanercept: 2 weeks
. Adalimumab and certolizumab: 4 weeks
. Abatacept, tocilizumab and golimumab: 8 weeks
. Rituximab: 6 months
. Anakinra: 3 days No treatment with biologics is allowed during the first 12 weeks after the start of the study treatment. Thus, the patients should have complied with the periods indicated above, and should not receive any biologics during the period specified.
. Presence of a severe bleeding or thrombotic disorder.