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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
Pinnacle Research Group
Anniston, Alabama, United States
Arthrocare Arthritis Care and Research PC
Gilbert, Arizona, United States
Triwest Research Associates
El Cajon, California, United States
UCLA
Los Angeles, California, United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
Arthritis Center
Palm Harbor, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
McIlwain Medical Group
Tampa, Florida, United States
JHU Arthritis Center Baltimore
Baltimore, Maryland, United States
...and 13 more locations
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
To evaluate the safety, tolerability and feasibility of a single intravenous (IV) 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 oral DMARDs for at least 4 months and who have had an incomplete response to at least one course of a TNFα inhibitor. Overall safety will be based on the overall assessment of AE/SAEs, Vital Signs, Physical Examination, clinical laboratory tests, ECGs and Chest x-ray.
Time frame: 12 weeks post IV Infusion
Evaluation of the efficacy of a single intravenous infusion of allogeneic MPCs compared with placebo at 12 weeks post-infusion with MPCs or placebo in the treatment of patients with active RA
To assess the efficacy of a single intravenous infusion of allogeneic MPCs compared with placebo at 12 weeks post-infusion with MPCs or placebo in the treatment of patients with active RA who have received methotrexate +/- other DMARDs for at least 4 months and who have had an incomplete response to least one TNFα inhibitor.
Time frame: 12 weeks post IV infusion with MPCs
Evaluation of long-term safety and efficacy of a singly IV infusion of allogeneic MPCs in patients with active RA
To evaluate the long-term efficacy and safety of allogeneic MPCs over the entire study duration in the treatment of patients with active RA who have received methotrexate +/- other DMARDs for at least 4 months and who have had an incomplete response to at least one TNFα inhibitor Safety will be assessed according to the following: * Adverse events/serious adverse events ("primary endpoint") * Vital signs * Physical examination * Clinical laboratory tests * Electrocardiogram * Chest x-ray (CXR) Efficacy will be assessed according to the following: * ACR20/50/70 * DAS28 (mean changes from baseline as measured by using hsCRP and ESR) * Mean changes from baseline in all components of the ACR core response criteria * Remissions (as defined in the 2011 Joint Statement of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) * Joint erosion of hands and wrists assessed via x-ray * Patient-reported outcomes * SF36v2 * HAQ\_DI
Time frame: 52 weeks post IV Infusion
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