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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01851070
Registration number
NCT01851070
Ethics application status
Date submitted
19/04/2013
Date registered
10/05/2013
Date last updated
26/06/2020
Titles & IDs
Public title
A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor
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Scientific 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 TNFa Inhibitor
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Secondary ID [1]
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MSB-RA001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Placebo comparator: Normal Saline Placebo - Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
Active comparator: 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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
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Assessment method [1]
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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 TNFa 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.
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Timepoint [1]
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12 weeks post IV Infusion
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Secondary outcome [1]
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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
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Assessment method [1]
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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 TNFa inhibitor.
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Timepoint [1]
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12 weeks post IV infusion with MPCs
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Secondary outcome [2]
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Evaluation of long-term safety and efficacy of a singly IV infusion of allogeneic MPCs in patients with active RA
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Assessment method [2]
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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 TNFa 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
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Timepoint [2]
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52 weeks post IV Infusion
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Eligibility
Key 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 TNFa 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
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Minimum age
18
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 TNFa 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2017
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Southern Clinical Research Pty Ltd - Hobart
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Recruitment hospital [3]
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Emeritus Research - Malvern
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3145 - Malvern
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Florida
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Maryland
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Massachusetts
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Minnesota
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New Jersey
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North Carolina
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Oklahoma
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Pennsylvania
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Tennessee
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United States of America
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mesoblast, Ltd.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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PPD
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT01851070
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Donna Skerrett, MD, MS
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Address
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Mesoblast, Ltd.
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01851070
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