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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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New South Wales
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Camperdown, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital
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Tasmania
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Hobart, Tasmania, Australien, 7000
- Southern Clinical Research Pty Ltd
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Victoria
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Malvern, Victoria, Australien, 3145
- Emeritus Research
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-
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Alabama
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Anniston, Alabama, Förenta staterna, 36207
- Pinnacle Research Group
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Arizona
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Gilbert, Arizona, Förenta staterna, 85234
- Arthrocare Arthritis Care and Research PC
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California
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El Cajon, California, Förenta staterna, 92020
- TriWest Research Associates
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Los Angeles, California, Förenta staterna, 90025
- UCLA
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Upland, California, Förenta staterna, 91786
- Inland Rheumatology Clinical Trials Incorporated
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Florida
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Ocala, Florida, Förenta staterna, 34474
- Ocala Rheumatology Research Center
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Palm Harbor, Florida, Förenta staterna, 34684
- Arthritis Center
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Sarasota, Florida, Förenta staterna, 34239
- Sarasota Arthritis Research Center
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Tampa, Florida, Förenta staterna, 33614
- McIlwain Medical Group
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Maryland
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Baltimore, Maryland, Förenta staterna, 21224
- JHU Arthritis Center Baltimore
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Frederick, Maryland, Förenta staterna, 21702
- Arthritis Treatment Center
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Massachusetts
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Worcester, Massachusetts, Förenta staterna, 01605
- Reliant Medical Group
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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New Jersey
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Fair Lawn, New Jersey, Förenta staterna, 07410
- Office of Ramesh C. Gupta, MD
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28210
- DJL Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73102
- Health Research of Oklahoma
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15261
- University of Pittsburgh
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Tennessee
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Jackson, Tennessee, Förenta staterna, 38305
- West Tennessee Research Institute
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Texas
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Houston, Texas, Förenta staterna, 77034
- Accurate Clinical Research
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San Antonio, Texas, Förenta staterna, 78217
- Texas Arthritis Research Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Normal Saline Placebo
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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.
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12 weeks post IV infusion with MPCs
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Evaluation of long-term safety and efficacy of a singly IV infusion of allogeneic MPCs in patients with active RA
Tidsram: 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:
Efficacy will be assessed according to the following:
|
52 weeks post IV Infusion
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2013
Primärt slutförande (Faktisk)
1 maj 2016
Avslutad studie (Faktisk)
1 mars 2017
Studieregistreringsdatum
Först inskickad
19 april 2013
Först inskickad som uppfyllde QC-kriterierna
9 maj 2013
Första postat (Uppskatta)
10 maj 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 juni 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2020
Senast verifierad
1 juni 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MSB-RA001
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