A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/17/2018 |
Start Date: | July 2013 |
End Date: | March 2017 |
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 TNFα Inhibitor
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.
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.
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 joint count (TJC) 28 joint count at screening and
- ≥ 4 swollen joint count (SJC) count 28 joint count at screening
- ESR ≥ 28 mm/hr or hsCRP >2.0 mg/L
- 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
We found this trial at
21
sites
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Baltimore, Maryland 21224
Principal Investigator: Grant Louie, MD
Phone: 410-550-0579
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Charlotte, North Carolina 28210
Principal Investigator: Emily Box, MD
Phone: 704-541-9092
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Fair Lawn, New Jersey 07410
Principal Investigator: Ramesh Gupta, MD
Phone: 901-681-9670
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Frederick, Maryland 21702
Principal Investigator: Nathan Wei, MD
Phone: 301-624-1167
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Houston, Texas
Principal Investigator: Philip Waller, MD
Phone: 281-481-8557
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Jackson, Tennessee 38305
Principal Investigator: Jacob Aelion, MD
Phone: 731-951-0249
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Suzanne Kafaja, MD
Phone: 310-825-9682
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Ocala, Florida 34474
Principal Investigator: Stephen Bookbinder, MD
Phone: 352-861-6931
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Oklahoma City, Oklahoma 73103
Principal Investigator: Christine Codding, MD
Phone: 405-702-6770
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Rochester, Minnesota 55905
Principal Investigator: Eric L Matteson, MD
Phone: 507-284-3695
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Upland, California 91786
Principal Investigator: Antony Hou, MD
Phone: 909-296-8701
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