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 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
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Anniston、Alabama、アメリカ、36207
- Pinnacle Research Group
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Arizona
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Gilbert、Arizona、アメリカ、85234
- Arthrocare Arthritis Care and Research PC
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California
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El Cajon、California、アメリカ、92020
- Triwest Research Associates
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Los Angeles、California、アメリカ、90025
- UCLA
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Upland、California、アメリカ、91786
- Inland Rheumatology Clinical Trials Incorporated
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Florida
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Ocala、Florida、アメリカ、34474
- Ocala Rheumatology Research Center
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Palm Harbor、Florida、アメリカ、34684
- Arthritis Center
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Sarasota、Florida、アメリカ、34239
- Sarasota Arthritis Research Center
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Tampa、Florida、アメリカ、33614
- McIlwain Medical Group
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Maryland
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Baltimore、Maryland、アメリカ、21224
- JHU Arthritis Center Baltimore
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Frederick、Maryland、アメリカ、21702
- Arthritis Treatment Center
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Massachusetts
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Worcester、Massachusetts、アメリカ、01605
- Reliant Medical Group
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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New Jersey
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Fair Lawn、New Jersey、アメリカ、07410
- Office of Ramesh C. Gupta, MD
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North Carolina
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Charlotte、North Carolina、アメリカ、28210
- DJL Clinical Research
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73102
- Health Research of Oklahoma
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15261
- University of Pittsburgh
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Tennessee
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Jackson、Tennessee、アメリカ、38305
- West Tennessee Research Institute
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Texas
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Houston、Texas、アメリカ、77034
- Accurate Clinical Research
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San Antonio、Texas、アメリカ、78217
- Texas Arthritis Research Center
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New South Wales
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Camperdown、New South Wales、オーストラリア、2050
- Royal Prince Alfred Hospital
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Tasmania
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Hobart、Tasmania、オーストラリア、7000
- Southern Clinical Research Pty Ltd
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Victoria
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Malvern、Victoria、オーストラリア、3145
- Emeritus Research
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:Normal Saline Placebo
Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes.
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アクティブコンパレータ: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Evaluation of the safety of a single IV infusion of allogeneic MPCs compared to placebo at 12 weeks post-infusion
時間枠:12 weeks post IV Infusion
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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 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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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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
時間枠:12 weeks post IV infusion with MPCs
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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 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
時間枠:52 weeks post IV Infusion
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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 TNFα inhibitor Safety will be assessed according to the following:
Efficacy will be assessed according to the following:
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52 weeks post IV Infusion
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協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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