初期の dcSSc におけるブレンツキシマブ ベドチンの非盲検延長研究
活動性びまん性皮膚全身性硬化症（びまん性強皮症）におけるブレンツキシマブ ベドチン治療の非盲検延長試験
The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.
調査の概要
詳細な説明
Systemic sclerosis (SSc, Scleroderma) is a multisystem autoimmune disease characterized by widespread vascular injury and progressive fibrosis of the skin and internal organs. Internal organ involvement results in increased mortality of SSc patients. There is no effective treatment for the majority of patients with early active diffuse scleroderma (diffuse cutaneous systemic sclerosis; dcSSc). It's possible to reverse immune inflammation and reduce the probability of irreversible fibrosis early in the disease course via significant immune modulation. The preliminary results of the Phase II study of Brentuximab vedotin (Protocol BV201708) in SSc demonstrated the short-term safety and benefits of this treatment as many participants already achieved the primary endpoint at 24 weeks. This study is proposed as an extension of the ongoing protocol for up to 48 weeks to make the treatment available for SSc patients who have significantly improved on Brentuximab vedotin, but relapsed after discontinuation of the treatment. Similar to the ongoing Phase II study, the Health Assessment Questionnaire Disability Index (HAQ-DI), patient and physician global scores, inflammatory markers (ESR, CRP), and combined response index in SSc (CRISS) and changes in CD30-stained cells on skin biopsies with IHC will all be exploratory outcomes.
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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Ontario
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London、Ontario、カナダ、N6A 4V2
- Rheumatology Clinic, St. Joseph's Health Care
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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:
- Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:
- Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).
- Able to give informed consent.
Exclusion Criteria:
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Poor pulmonary function (FVC<40% and/or DLCO<30%).
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Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).
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Clinically significant pulmonary hypertension requiring drug therapy.
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Clinically significant cardiac disease.
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Chronic or ongoing active infectious disease requiring systemic treatment.
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Seropositivity for human immunodeficiency virus (HIV).
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Active tuberculosis (TB) infection.
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Active viral infection with viral replication of hepatitis B or C virus.
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Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.
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Peripheral neuropathy at screening Grade 2 or higher.
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Known or suspected hypersensitivity to components of the treatment
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Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
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Any of the following laboratory abnormalities at screening:
- Absolute neutrophils count <2.0 x 109/L
- Hemoglobin <85 g/L
- Platelet count < 100 x 109/L
- AST/SGOT or ALT/SGPT >2.0 UNL
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Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.
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Use of rituximab within the previous 4 months.
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Immunization with a live/ attenuated vaccine less than 4 weeks prior to the baseline visit.
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Current or history of progressive multifocal leukoencephalopathy (PML).
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Administration of Brentuximab vedotin
Maximum duration of treatment: 48 weeks Maximum dose allowed: 0.6 mg/kg Route of administration: intravenous |
Dose 0.6mg/kg will be given every 3 weeks for 16 cycles (48 weeks), in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil (MMF, cellcept) and mycophenolic acid (myfortic)
他の名前：
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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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Change in skin thickness measured by modified Rodnan Skin Score
時間枠：48 weeks
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Skin improvement is defined as the mean mRSS decrease of ≥8 points modified Rodnan Skin Score (mRSS): is a standard outcome measure for skin disease in SSc and calculated by measuring skin thickness in 17 different body sites (each site scored 0-3, with a total possible additive score of 51). A higher skin score (or a higher "skin thickness") and progression of this score, is predictive of internal organ involvement and mortality. While a lower or improving (lessening) score is associated with favorable outcomes, including better survival. |
48 weeks
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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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Change in skin thickness over time measured by modified Rodnan Skin Score
時間枠：12 weeks and 36 weeks
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modified Rodnan Skin Score (mRSS): is a standard outcome measure for skin disease in SSc and calculated by measuring skin thickness in 17 different body sites (each site scored 0-3, with a total possible additive score of 51). A higher skin score (or a higher "skin thickness") and progression of this score, is predictive of internal organ involvement and mortality. While a lower or improving (lessening) score is associated with favorable outcomes, including better survival. |
12 weeks and 36 weeks
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Change in physician global assessment of disease activity
時間枠：12, 24, 36, and 48 weeks.
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Measured on a Visual Analogue Scale (VAS) from 0-10, with 0 being no disease activity and 10 being the worst possible disease activity. |
12, 24, 36, and 48 weeks.
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Change in physician global assessment of disease severity
時間枠：12, 24, 36, and 48 weeks
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Measured on a Visual Analogue Scale (VAS) from 0-10, with 0 being no disease severity and 10 being the worst possible disease severity. |
12, 24, 36, and 48 weeks
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Change in physician global assessment of disease damage
時間枠：12, 24, 36, and 48 weeks
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Measured on a Visual Analogue Scale (VAS) from 0-10, with 0 being no disease damage and 10 being the worst possible disease damage. |
12, 24, 36, and 48 weeks
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Change in patient global assessment of health status
時間枠：12, 24, 36, and 48 weeks
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Measured on a Visual Analogue Scale (VAS) from 0-100, with 0 being no overall effect of disease on participant, and 100 being the worst possible overall effect of disease on participant. This is a patient reported outcome. |
12, 24, 36, and 48 weeks
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Change in Scleroderma Health Assessment Questionnaire (SHAQ)
時間枠：12, 24, 36, and 48 weeks
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The SHAQ combines the disability and pain scales of the HAQ (HAQ-DI), with five scleroderma-specific Visual Analogue Scales for: digital ulcers, Raynaud's phenomenon, gastrointestinal (GI) symptoms, lung symptoms, and overall disease severity. The HAQ-DI yields a score of 0-3, that indicates the extent of the respondent's functional limitations. Each VAS score is scaled from 0 to 3, with 0 being no symptoms and 3 being the worst possible symptom severity. A composite VAS score is not created nor are the individual VAS scores incorporated into the HAQ DI score. Typically, each VAS score is reported individually. There is a proposed way to obtain a combined score obtained by pooling the 8 domains of the HAQ DI and the 5 VASs; however, this approach has not yet been widely accepted. This is a patient reported outcome. |
12, 24, 36, and 48 weeks
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Change in the diffusing capacity for carbon monoxide (pulmonary function)
時間枠：24 and 48 weeks*
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Change in Pulmonary Function as measured by percentage of Improving or worsening DLCO. The DLCO (diffusing capacity of the lungs for carbon monoxide) measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. % Improving/worsening DLCO. Analyzed as an ordinal outcome. *PFT (pulmonary function test) results will only be analyzed as available under standard of care. |
24 and 48 weeks*
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Change in Forced Vital Capacity (pulmonary function)
時間枠：24 and 48 weeks*
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Change in Pulmonary Function as measured by percentage of Improving or worsening FVC. The FVC (Forced vital Capacity) is the total amount of air exhaled during the FEV (Forced expiratory volume) test. % Improving/worsening FVC. Analyzed as an ordinal outcome. *PFT (pulmonary function test) results will only be analyzed as available under standard of care. |
24 and 48 weeks*
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Combined Response Index in diffuse cutaneous systemic sclerosis score (CRISS)
時間枠：Baseline (week 0), and at 24, 48 weeks
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To define disease progression CRISS score: It is calculated according to changes from the start of a study, compared to an endpoint, by using the modified Rodnan Skin Score (mRSS), the Health Assessment Questionnaire - Disability Index (HAQ-DI), patient and physician global assessment of scleroderma-related health, and forced vital capacity. A CRISS score of ≥ 0.6 indicates likelihood that a patient improved on treatment. |
Baseline (week 0), and at 24, 48 weeks
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Change in serum concentrations C-Reactive Protein
時間枠：12, 24, 36, and 48 weeks
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Change in serum concentrations of the acute phase reactant, CRP CRP aids in the evaluation of stress, trauma, infection, inflammation, surgery & associated diseases. Blood levels of C-Reactive Protein (CRP) are known to rise in acute disease to a level of up to 50 mg/L in the presence of slight to moderate inflammatory process. Values >50 mg/L indicate high and extensive inflammatory activity. |
12, 24, 36, and 48 weeks
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Change in serum concentrations of Erythrocyte Sedimentation Rate
時間枠：12, 24, 36, and 48 weeks
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Change in serum concentrations of the acute phase reactant, ESR Reference ranges: Male: 0-10 mm/h Female: 0-20 mm/h A faster-than-normal rate may indicate inflammation in the body. Inflammation is part of the immune response system. The higher the number, the higher the likelihood of inflammation. |
12, 24, 36, and 48 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Regimen-related toxicities
時間枠：assessed for duration of treatment up to 48 weeks, and up to 12 weeks post-treatment
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Defined as Adverse Events (AEs) >= Grade 3 and assessed by the investigator as 1 of the following: related or unrelated to treatment. |
assessed for duration of treatment up to 48 weeks, and up to 12 weeks post-treatment
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Infectious complications
時間枠：assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment
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Any infectious complication will be tracked under Adverse Event recording |
assessed for duration of treatment up to 48 weeks, and up to 1 month post-treatment
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Change in peripheral levels of T-cell activation marker - sIL-2R
時間枠：12, 24, 36, and 48 weeks
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interleukin 2 receptor (sIL-2R) Serum sIL-2R level is a sensitive and quantitative marker of circulating peripheral blood mononuclear cell activation. Normal range of serum sIL-2R is below 2500 pg/ml. High levels may be found in conditions associated with T-cell activation. |
12, 24, 36, and 48 weeks
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Change in peripheral levels of fibrillogenesis - amino terminal propeptide of type III collagen
時間枠：12, 24, 36, and 48 weeks
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Changes in serum amino-terminal propeptide of type III collagen levels. Amino-terminal propeptide of procollagen type III (PIIINP) is generated during the synthesis of type III collagen. PIIINP is a non-specific marker of soft tissue injury. PIIINP in serum has been shown to correlate with fibrillogenesis, and thus to be a potential direct marker of type III collagen deposition. PIIINP reference range Adult (>19 years): 1.2 - 4.2 ug/L and myofibroblast score in skin biopsies (24 and 48 weeks) if the study looks favorable with respect to potential benefit and safety. |
12, 24, 36, and 48 weeks
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Change in CD30-positive cell count (T-cell marker) in skin biopsies of involved forearm skin
時間枠：Taken at Baseline (week 0), and 24, 48 weeks
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Measured by immunohistochemistry (IHC) as the percentage of CD30-positive cells per total number of cells/mm2. Reference rage not established (there is no range, we are looking for a stat significant change (decrease) from baseline) |
Taken at Baseline (week 0), and 24, 48 weeks
|
協力者と研究者
捜査官
- 主任研究者：Janet E Pope, PhD、University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada
出版物と役立つリンク
一般刊行物
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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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BV202108
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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