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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Normal Saline Placebo
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
Medicin: Allogeneic Mesenchymal Precursor Cells
Aktiv komparator: 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.
Medicin: Normal saltvand

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mesoblast, Ltd.

Samarbejdspartnere

PPD

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2013

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

19. april 2013

Først indsendt, der opfyldte QC-kriterier

9. maj 2013

Først opslået (Skøn)

10. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MSB-RA001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med Normal saltvand

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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