EUCTR2010-020839-39-BE进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056
CB Biosciences, Inc. A Member of the UCB Group of Companies0 个研究点目标入组 220 人开始时间: 2010年11月25日最近更新:
适应症
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
- 220
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
- •To be eligible to participate in this study, all of the following criteria must be met:
- •1. Subject must be able to understand the information provided to them, be given ample time and opportunity to ask questions and to decide whether or not to participate, and provide written informed consent. The subject should also be able to communicate satisfactorily with the Investigator and be willing to participate in the study and to comply with all study requirements.
- •2. Subject must be at least 18 years old at Screening.
- •3. Subject must have a diagnosis of adult-onset RA of at least 6 months’ (24 weeks)
- •duration as defined by the 1987 ACR classification criteria (Arnett et al, 1988) or a score of =6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA (Aletaha et al, 2010).
- •4. Subject must have moderately to severely active RA disease as defined by each of the following:
- •? =6 tender joints (68-joint count) at Screening and Baseline
- •? =6 swollen joints (66-joint count) at Screening and Baseline
- •? CRP =1.2 times the upper limit of normal (ULN) (central laboratory) or ESR
- •>28mm/hour (Westergren)
- •5. Subject must be on a dose of MTX between 15 to 25mg/week, which has been stable for at least 6 weeks prior to Screening with a stable route of administration. Subjects may be dosed with 10 to less than 15mg weekly if they have documented reasons of toxicity.
- •6. Subject must have had intolerance or inadequate response to treatment (ie, TNF-blocker failure) with 1 or more licensed TNF-blocker therapies (etanercept, infliximab,
- •golimumab, certolizumab pegol, or adalimumab) within 2 years of Screening.
- •7. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study. Female subjects of childbearing potential must agree to use adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 dose. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038.
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Rheumatoid arthritis disease-related and other treatment-related exclusions:
- •1. Subjects who have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis, ankylosing spondylitis, or gout, or lupus).
- •2. Subjects who have a secondary, noninflammatory type of arthritis (eg, osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of IMP on the subject’s primary diagnosis of RA.
- •3. Subject who is Steinbrocker IV functional capacity.
- •4. Subjects must be free of the prohibited medications (as detailed in section 6.2 of the study protocol)
- •5. Subjects must be free of biological therapy (as detailed in section 6.2 of the study protocol)
- •6. Participation in any other clinical drug or device study (including a biologic product)
- •within 12 weeks or 5 half-lives, or within protocol-specified durations for specific agents, whichever is longer, prior to Baseline.
- •Medical history-related exclusions:
- •7. Subject has a creatinine level, an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level, platelets or a white blood cell count, or a neutrophil count at Screening in accordance with the protocol parameters (refer to protocol).
- •8. Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks following last dose of IMP.
- •9. Subjects who have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
- •10. Subject with a history of chronic or recurrent infections (refer to protocol).
- •11. Subjects with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
- •12. Subjects at high risk of infection (eg, presence of leg ulcers or an indwelling urinary catheter, bedridden, or wheelchair-bound subjects).
- •13. Subjects with known concurrent acute or chronic viral hepatitis B or C infection.
- •14. Subjects with known human immunodeficiency virus (HIV) infection.
- •15. Subject has known TB disease, high risk of acquiring TB infection, or latent TB infection (refer to protocol).
- •16. Subjects that have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted).
- •17. Concurrent malignancy or a history of malignancy (refer to protocol).
- •18. Subjects with a history of a lymphoproliferative disorder, including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
- •19. Subjects with a history or presence of cardiovascular, respiratory, hepatic, renal,
- •gastrointestinal, endocrinological, dermatological, neurological, psychiatric,
- •hematological (including bleeding disorder), or immunologic/immunodeficiency
- •disorder(s) which are clinically significant enough in the opinion of the Investigator or
- •Sponsor to alter the absorption and disposition of IMP, or constitute a possible
- •confounding factor for assessment of efficacy or safety of the IMP.
- •20. Subjects with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac (including Class IV congestive heart failure according to the New York Heart Association 1964 classification criteria [Criteria Committee of the New York Heart Association, 1964], neurological (including cerebral diseas
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