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

NCT ID: NCT01851070

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-03-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Normal Saline Placebo

Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.

Group Type: PLACEBO_COMPARATOR

Allogeneic Mesenchymal Precursor Cells

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: DRUG

Interventions

Allogeneic Mesenchymal Precursor Cells

Intervention Type: DRUG

Normal Saline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Mesoblast, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donna Skerrett, MD, MS

Role: STUDY_DIRECTOR

Mesoblast, Ltd.

Locations

Pinnacle Research Group

Anniston, Alabama, United States

Arthrocare Arthritis Care and Research PC

Gilbert, Arizona, United States

Triwest Research Associates

El Cajon, California, United States

UCLA

Los Angeles, California, United States

Inland Rheumatology Clinical Trials Incorporated

Upland, California, United States

Ocala Rheumatology Research Center

Ocala, Florida, United States

Arthritis Center

Palm Harbor, Florida, United States

Sarasota Arthritis Research Center

Sarasota, Florida, United States

McIlwain Medical Group

Tampa, Florida, United States

JHU Arthritis Center Baltimore

Baltimore, Maryland, United States

Arthritis Treatment Center

Frederick, Maryland, United States

Reliant Medical Group

Worcester, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Office of Ramesh C. Gupta, MD

Fair Lawn, New Jersey, United States

DJL Clinical Research

Charlotte, North Carolina, United States

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

Accurate Clinical Research

Houston, Texas, United States

Texas Arthritis Research Center

San Antonio, Texas, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Southern Clinical Research Pty Ltd

Hobart, Tasmania, Australia

Emeritus Research

Malvern, Victoria, Australia

Countries

United States; Australia

Other Identifiers

MSB-RA001

Identifier Type: -

Identifier Source: org_study_id