Status and phase
Conditions
Treatments
About
Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who have had an incomplete response to at least one TNF-alpha inhibitor.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males and Females ages 18-80 years old
Active rheumatoid arthritis (RA) disease as per 2010 ACR/EULAR classification criteria for the diagnosis of RA.
Must be positive for rheumatoid factor and/or anti-cyclic citrullinated peptide (anti-CCP3) but without extra-articular disease or functional limitation
Patient with active RA defined as:
Patient has been taking MTX for at least 4 months with dose and route of administration stable for at least 8 weeks prior to screening
Patient has had an inadequate response to at least one TNFα inhibitor with last dose at least 6 weeks prior to screening
Use of oral DMARD (sulfasalazine, hydroxychloroquine, chloroquine and leflunomide) is permitted but must be stable for at least 3 months prior to screening
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal