Rheumatoid ArthritisPhase 2NCT01851070
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
A Phase 2 study testing Allogeneic Mesenchymal Precursor Cells and Normal Saline in people with Rheumatoid Arthritis, run by Mesoblast, Ltd. at 23 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Allogeneic Mesenchymal Precursor Cells and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jul 2013to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Pinnacle Research Group
Anniston, Alabama, 36207
JHU Arthritis Center Baltimore
Baltimore, Maryland, 21224
DJL Clinical Research
Charlotte, North Carolina, 28210
Triwest Research Associates
El Cajon, California, 92020
Office of Ramesh C. Gupta, MD
Fair Lawn, New Jersey, 07410
Arthritis Treatment Center
Frederick, Maryland, 21702
Arthrocare Arthritis Care and Research PC
Gilbert, Arizona, 85234
Accurate Clinical Research
Houston, Texas, 77034
West Tennessee Research Institute
Jackson, Tennessee, 38305
UCLA
Los Angeles, California, 90025
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73102
Arthritis Center
Palm Harbor, Florida, 34684
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Mayo Clinic
Rochester, Minnesota, 55905
Texas Arthritis Research Center
San Antonio, Texas, 78217
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
McIlwain Medical Group
Tampa, Florida, 33614
Inland Rheumatology Clinical Trials Incorporated
Upland, California, 91786
Reliant Medical Group
Worcester, Massachusetts, 01605
Australia3 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Southern Clinical Research Pty Ltd
Hobart, Tasmania, 7000
Emeritus Research
Malvern, Victoria, 3145
About this study
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
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
- Being tested
- Allogeneic Mesenchymal Precursor Cells, Normal Saline
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Mesenchymal Precursor CellsDrug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Placebo | Placebo comparator | Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes. Receives: Drug: Allogeneic Mesenchymal Precursor Cells |
| Allogeneic Mesenchymal Precursor Cells | Active comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-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.
Measured: 12 weeks post IV Infusion
Secondary outcomes (2)
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
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.
Measured: 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
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
Measured: 52 weeks post IV Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Donna Skerrett, MD, MS, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851070
- Sponsor's protocol ID
- MSB-RA001
- Status last verified
- Jun 2020
- First submitted
- 19 Apr 2013
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01851070
- Acronym / sponsor ID
- MSB-RA001
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Jul 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Placebo | Placebo comparator | Drug: Allogeneic Mesenchymal Precursor CellsPlacebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes. |
| Allogeneic Mesenchymal Precursor Cells | Active comparator | Drug: Normal SalineMesenchymal 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Mesenchymal Precursor Cells | Drug | Normal Saline Placebo |
| Normal Saline | Drug | Allogeneic Mesenchymal Precursor Cells |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Skerrett, MD, MS study director
Mesoblast, Ltd.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Mesenchymal Precursor Cells and Normal Saline in people with Rheumatoid Arthritis, run by Mesoblast, Ltd. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.