EUCTR2014-005323-27-GB进行中（未招募）1 期
A phase II study to evaluate subcutaneous abatacept vs. placebo in diffuse cutaneous systemic sclerosis—a double-blind, placebo-controlled, randomized controlled trial - The Abatacept Systemic SclErosis Trial (ASSET)
niversity of Michigan0 个研究点目标入组 86 人开始时间: 2015年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Signed Written Informed Consent
- •2. Diagnosis of SSc, as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
- •3. dcSSc as defined by LeRoy and Medsger
- •4. Disease duration of = 36 months (defined as time from the first non-Raynaud phenomenon manifestation)
- •For disease duration of = 18 months
- •? = 10 and = 25 mRSS units at the screening visit
- •For disease duration of >18-36 months
- •? = 15 and = 45 mRSS units at the screening visit and one of the following:
- •1. Increase = 3 in mRSS units compared with the last visit within previous 1–6 months
- •2. Involvement of one new body area with = 2 mRSS units compared with the last visit within the previous 1–6 months
- •3. Involvement of two new body areas with = 1 mRSS units compared with the last visit within the previous 1–6 months
- •4. Presence of 1 or more Tendon Friction Rub
- •5. Age = 18 years at the screening visit
- •6. If female of childbearing potential (see 4.2.3), the patient must have a negative pregnancy test at screening and baseline visits
- •7. Oral corticosteroids (= 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for = 2 weeks prior to and including the baseline visit
- •8. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for = 2 weeks prior to and including the baseline visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
- •2. Limited cutaneous SSc or sine scleroderma at the screening visit
- •3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
- •4. Any infected ulcer prior to randomization
- •5. Treatment with any investigational agent within = 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
- •6. Severe (MRSS 3+) skin on the inner aspects of thighs, upper arms, and abdomen
- •7. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA
- •8. Anti-CD20, and cyclophosphamide within 12 months prior to the baseline visit
- •9. Use of Intravenous Immunoglobulin (IVIG) within12 weeks prior to the baseline visit
- •10. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
- •11. Immunization with a live/attenuated vaccine within = 4 weeks prior to the baseline visit
- •12. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, D-penicillamine, within = 4 weeks prior to the baseline visit
- •13. Treatment with etanercept within = 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within = 8 weeks, anakinra within = 1 week prior to the baseline visit
- •14. Pulmonary disease with FVC = 50% of predicted, or DLCO (uncorrected for hemoglobin) = 40% of predicted at the screening visit
- •15. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud’s and digital ulcers.
- •16. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (= 4 weeks).
- •17. Positive for hepatitis B surface antigen prior to the baseline visit
- •18. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit
- •19. Any of the following prior to the baseline visit:
- •? Hemoglobin <8.5 g/dL;
- •? WBC < 3,000/mm3 (<3 x 109/L);
- •? platelets < 100,000/mm3 (<3 x 109/L);
- •? serum creatinine > 2 x ULN; or
- •? serum ALT or AST > 2 x ULN
- •20. Any other laboratory test results that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the study.
- •21. The following medical history and concurrent diseases:
- •Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
- •? Subjects with active va
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