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 range18 Years
SexALL
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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.
✓. Be receiving treatment on an outpatient basis.
Exclusion criteria
✕. 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
What they're measuring
1
Number of Adverse Events and Severe Adverse Events
Timeframe: 6 months follow up after the first administration
. 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.