Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments allogeneic mesenchymal precursor cells, normal saline
Phase phase 2
Sponsor Mesoblast, Ltd.
Start date May 2013
End date April 2017
Trial size 48 participants
Trial identifier NCT01851070, MSB-RA001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
allogeneic mesenchymal precursor cells
(Active Comparator)
Mesenchymal Precursor Cells (MPCs), either 1.0 or 2.0 million cells/kg, will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
normal saline

Primary Outcomes

Measure
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
time frame: 12 weeks post IV Infusion

Secondary Outcomes

Measure
Demonstration of efficacy of allogeneic MPCs compared to placebo at 12 weeks post-infusion with MPCs or placebo in the treatment of patients with active rheumatoid arthritis
time frame: 12 weeks post IV infusion with MPCs
Long-term evaluation of safety and efficacy of a singly IV infusion of allogeneic MPCs in patients with active RA who have received methotrexate +/- other DMARDs for at least 6 months and who have had an incomplete response to at least one TNF-alpha inhi
time frame: 78 weeks post IV Infusion

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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: - 4 tender joints (TJC) count (28 joint count) at screening and - 4 swollen joints (SJC) count (28 joint count) at screening - ESR ≥ 28 mm/hr OR hsCRP greater than ULN - 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: - Pregnant women or women who are breastfeeding. - Other investigational therapy received within 8 weeks or five half-lives (whichever is longer) prior to Screening (except as in exclusion #13). - Known or suspected alcohol or drug abuse within three years preceding Screening. - Autoimmune disease other than RA (such as systemic lupus erythematosus (SLE), mixed connective tissue disease, scleroderma, polymyositis/dermatomyositis, vasculitis) - History of or current inflammatory joint disease other than RA (such as tophaceous gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthropathy, Lyme disease). Patients primarily diagnosed with osteoarthritis are excluded. - Bedridden or confined to a wheelchair or patients with > 3 arthroplasties due to RA. - History of diagnosed and/or treated malignancy with no evidence of recurrence in past 5 years - Surgical procedures planned to occur during the trial (these patients may be rescreened following completion of and recovery from the surgical procedure). - Use of TNFα inhibitor for treatment of RA at time of screening or within the 6 weeks prior to screening. - Prior use of biologic agent for treatment of RA within 6 weeks prior to screening

Additional Information

Official title A Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNF Alpha Inhibitor.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mesoblast, Ltd..