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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

25 juni 2020 bijgewerkt door: Mesoblast, Ltd.

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

48

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • New South Wales
      • Camperdown, New South Wales, Australië, 2050
        • Royal Prince Alfred Hospital
    • Tasmania
      • Hobart, Tasmania, Australië, 7000
        • Southern Clinical Research Pty Ltd
    • Victoria
      • Malvern, Victoria, Australië, 3145
        • Emeritus Research
  • Verenigde Staten
    • Alabama
      • Anniston, Alabama, Verenigde Staten, 36207
        • Pinnacle Research Group
    • Arizona
      • Gilbert, Arizona, Verenigde Staten, 85234
        • Arthrocare Arthritis Care and Research PC
    • California
      • El Cajon, California, Verenigde Staten, 92020
        • TriWest Research Associates
      • Los Angeles, California, Verenigde Staten, 90025
        • UCLA
      • Upland, California, Verenigde Staten, 91786
        • Inland Rheumatology Clinical Trials Incorporated
    • Florida
      • Ocala, Florida, Verenigde Staten, 34474
        • Ocala Rheumatology Research Center
      • Palm Harbor, Florida, Verenigde Staten, 34684
        • Arthritis Center
      • Sarasota, Florida, Verenigde Staten, 34239
        • Sarasota Arthritis Research Center
      • Tampa, Florida, Verenigde Staten, 33614
        • McIlwain Medical Group
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21224
        • JHU Arthritis Center Baltimore
      • Frederick, Maryland, Verenigde Staten, 21702
        • Arthritis Treatment Center
    • Massachusetts
      • Worcester, Massachusetts, Verenigde Staten, 01605
        • Reliant Medical Group
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic
    • New Jersey
      • Fair Lawn, New Jersey, Verenigde Staten, 07410
        • Office of Ramesh C. Gupta, MD
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28210
        • DJL Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73102
        • Health Research of Oklahoma
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15261
        • University of Pittsburgh
    • Tennessee
      • Jackson, Tennessee, Verenigde Staten, 38305
        • West Tennessee Research Institute
    • Texas
      • Houston, Texas, Verenigde Staten, 77034
        • Accurate Clinical Research
      • San Antonio, Texas, Verenigde Staten, 78217
        • Texas Arthritis Research Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Normal Saline Placebo
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
Geneesmiddel: Allogeneic Mesenchymal Precursor Cells
Actieve vergelijker: Allogeneic Mesenchymal Precursor Cells
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.
Geneesmiddel: Normale zoutoplossing

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
Tijdsspanne: 12 weeks post IV 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.
12 weeks post IV Infusion

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 12 weeks post IV infusion with MPCs
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.
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
Tijdsspanne: 52 weeks post IV Infusion

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
52 weeks post IV Infusion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mesoblast, Ltd.

Medewerkers

PPD

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2013

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 maart 2017

Studieregistratiedata

Eerst ingediend

19 april 2013

Eerst ingediend dat voldeed aan de QC-criteria

9 mei 2013

Eerst geplaatst (Schatting)

10 mei 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2020

Laatste update ingediend die voldeed aan QC-criteria

25 juni 2020

Laatst geverifieerd

1 juni 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MSB-RA001

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