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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

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ClinicalTrials.gov Identifier: NCT01851070
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Mesoblast, Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Allogeneic Mesenchymal Precursor Cells Drug: Normal Saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 TNFα Inhibitor
Actual Study Start Date : July 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : March 2017

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Normal Saline Placebo
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
 Drug: Allogeneic Mesenchymal Precursor Cells
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.
 Drug: Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion [ Time Frame: 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.



Secondary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. Evaluation of long-term safety and efficacy of a singly IV infusion of allogeneic MPCs in patients with active RA [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851070


  Show 23 Study Locations
Sponsors and Collaborators
Mesoblast, Ltd.
PPD
Investigators
Study Director: Donna Skerrett, MD, MS Mesoblast, Ltd.
More Information
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Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01851070     History of Changes
Other Study ID Numbers: MSB-RA001
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases