EUCTR2010-018674-20-FI进行中（未招募）不适用
A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 470
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
- 性别
- All
入选标准
- •1/ Signed Written Informed Consent
- •a) Subject is willing to participate in the study and signed the informed consent
- •2/ Target Population
- •a) Subjects have active clinical synovitis of at least 2 joints, 1 of which must be a
- •small joint, for at least 8 weeks at the Screening Visit. Distal interphalangeal
- •joints (DIP)s do not count toward this requirement
- •b) Subjects have had the onset of persistent symptoms for = 2 years prior to the
- •Screening Visit.
- •c) Subjects have a DAS28-CRP = 3.2 at the Screening Visit
- •d) Subjects are positive for anti-CCP2.
- •e) Subjects are MTX naive or have minimum exposure to MTX defined as no more
- •than 10 mg/wk for no more than 4 weeks and no dose for 1 month prior to the
- •Screening Visit.
- •f) Subjects are biologic naive and have not received treatment with an approved or
- •investigational biologic RA therapy (for ex, infliximab, etanercept, anakinra,
- •adalimumab, rituximab, tocilizumab, golimumab, and certolizumab) prior to screening.
- •.g) Subjects receiving chloroquin, hydroxychloroquine and sulfasalazine
- •treatment (wash-out) for a minumum of 28 days prior to randomization.
- •h) Subjects receiving oral corticosteroids must be on a stable dose and
- •at theequivalent of = 10 mg prednisone daily for = 4 weeks or may have
- •received an IM, IV or IA administration of a corticosteroid = 4 weeks
- •prior to randomization
- •3/ Age and Reproductive Status
- •a) Men and women, ages = 18
- •b) Men and women of childbearing potential (WOCBP) must be using an acceptable
- •method of contraception to avoid pregnancy throughout the study for up to
- •10 weeks (14 weeks for EU) after the last dose of abatacept in such a manner that
- •the risk of pregnancy is minimized. See Protocol Section 3.3.4 for the definition of WOCBP.
- •c) Women must have a negative serum or urine pregnancy test (minimum sensitivity
- •25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product.
- •d) Women must not be breastfeeding
- •e) Investigators should follow the manufacturer’s recommendations for MTX.
- •f) Subjects must be able to receive an MRI. See Protocol Section 3.3.4 for contraindications.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1/ Target Disease Exceptions
- •a) Subjects who meet diagnostic criteria for other rheumatic disease (eg, lupus
- •erythematosus).
- •2/ Medical History and Concurrent Diseases
- •a) Subjects who are impaired, incapacitated, or incapable of completing study
- •related assessments.
- •b) Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
- •hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral
- •disease. Concomitant medical conditions that, in the opinion of the investigator,
- •might place the subject at unacceptable risk for participation in this study.
- •c) Female subjects who had a breast cancer screening study that is suspicious for
- •malignancy, and in whom the possibility of malignancy cannot be reasonably
- •excluded following additional clinical, laboratory or other diagnostic evaluations
- •d) Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell
- •cancers must be removed prior to dosing. Subjects with carcinoma in situ, treated
- •with definitive surgical intervention prior to study entry, are allowed.
- •e) Subjects who have clinically significant drug or alcohol abuse.
- •f) Subjects with any serious acute bacterial infection (such as pneumonia or
- •pyelonephritis unless treated and completely resolved with antibiotics).
- •g) Subjects with severe chronic or recurrent bacterial infections (such as recurrent
- •pneumonia, chronic bronchiectasis).
- •h) Subjects at risk for tuberculosis (TB). Specifically, subjects with:
- •i) Current clinical, radiographic or laboratory evidence of active TB.
- •ii) A history of active TB within the last 3 years even if it was treated.
- •iii) 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.
- •iv) Latent TB which was not successfully treated. Subjects with a positive TB
- •screening test indicative of latent TB will not be eligible for the study unless
- •active TB infection has been ruled out and they have initiated treatment for
- •latent TB with isoniazid (INH) for at least 4 weeks prior to dosing of study
- •drug and they have a negative chest x-ray at enrollment. Such subjects should
- •complete 9 months of INH treatment.
- •i) Subjects with herpes zoster that resolved less than 2 months prior to enrollment.
- •j) Subjects with evidence (as assessed by the investigator) of active or latent
- •bacterial or viral infections at the time of potential enrollment, including subjects
- •with evidence of Human Immunodeficiency Virus (HIV) infection
- •3/ Physical and Laboratory Test Findings
- •a) Hepatitis B surface antigen-positive subjects.
- •b) Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR positive.
- •c) Subjects with any of the following laboratory values:
- •i) Hgb < 8.5 g/dL.
- •ii) WBC < 3,000/mm3 (3 x 109/L)
- •iii) Platelets < 100,000/mm3 (100 x 109/L).
- •iv) Serum creatinine > 2 times upper limit of normal.
- •v) Serum ALT or AST > 2 times upper limit of normal.
- •vi) Any other laboratory test results that, in the opinion of the investigator, might
- •place the subject at unacceptable risk for participation in this study.
- •4/ Allergies and Adverse Drug Reaction
- •5/ Prohibited Treatments and/or Therapies
- •a) Subjects who have had prior exposure to abatacept (CTLA4-Ig)
- 另有 1 项未显示
研究者
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