EUCTR2013-004148-49-PL进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
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
- Pfizer Inc.
- 入组人数
- 614
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. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- •2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •3. Male and female subjects aged 18 years or older at the time of informed consent. Where required by regulations, consent from a legal representative is required for all subjects who are younger than 20 years of age.
- •4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 6 months after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- •Female subjects who are not of childbearing potential must meet at least 1 of the following criteria:
- •a. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum FSH level in the laboratory’s reference range for postmenopausal females.
- •b. Have undergone a documented hysterectomy and/or bilateral oophorectomy.
- •c. Have medically confirmed ovarian failure.
- •All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy or bilateral oophorectomy) will be considered to be of childbearing potential.
- •5. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
- •classification criteria (see Appendix 1) for RA for at least a 4 month duration.
- •6. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA (see Appendix 2).
- •7. Moderately to severely active RA disease as defined by the following criteria:
- •a. = 6 tender joints (of 68 assessed) at both Screening and Baseline, and
- •b. = 6 swollen joints (of 66 assessed) at both Screening and Baseline, and
- •c. Hs-CRP =10 mg/L (=1 mg/dL) at Screening, performed by a central
- •laboratory. Subjects who do not meet this entry criteria but satisfy all other study entry criteria may have serum hs-CRP concentration re-tested once within 14 days and, if the repeat hs-CRP concentration is =10 mg/L
- •(=1 mg/dL), will be eligible to enroll into the study provided all other
- •inclusion/exclusion criteria are met.
- •8. Stable dose of oral or parenteral methotrexate of 10 to 25 mg/week. Subjects who cannot tolerate 10 to 25 mg/week methotrexate may take a lower dose of as low as 7.5 mg/week (as low as 6 mg/week in geographic regions where specified by local guidance). Subjects must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks prior to first dose of study drug.
- •9. Stable dose of oral folic (=5 mg once per week)
- •10. If receiving an oral corticosteroid, subjects must be on a stable dose of
- •= 10 mg/day of prednisone (or equivalent) for 4 weeks prior to the first dose of study drug, without any intramuscular (IM) or intra-articular (IA) corticosteroids within the 4 weeks prior to the first dose of study drug.
- •11. If receiving a NSAID/Cox-2 inhibitor, subject must be on a stable dose of only one NSAID/Cox-2 inhibitor drug for 4 weeks prior to the first dose of study drug at a dosage less than or equal to the maximum recom
排除标准
- •1. Pregnant females and breastfeeding females; males and females of
- •childbearing potential who are unwilling or unable to use a highly
- •effective method of contraception for the duration of the study and for at
- •least 6 months after last dose of investigational product. Females must
- •not breastfeed for at least 6 months after last dose of investigational
- •2. Clinically significant laboratory abnormalities at Screening, including
- •but not limited to inadequate bone marrow, liver, renal and immune
- •system functions.
- •3. Evidence or history of moderate or severe heart failure (NYHA class
- •III/IV, see Appendix 11 for NYHA classification of congestive heart
- •failure) and subjects who are contraindicated for treatment with
- •infliximab in accordance with the approved local label.
- •4. Evidence of current or recent history of uncontrolled, clinically
- •significant infectious, hematological, renal, endocrine, pulmonary,
- •gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
- •allergic disease.
- •5. Evidence or history of seizures, or nervous system demyelinating
- •6. Evidence or history of a malignancy within the past 5 years with the
- •exception of adequately treated or excised non-metastatic basal cell or
- •squamous cell cancer of the skin, or cervical carcinoma in situ with no
- •evidence of recurrence.
- •7. History of any lymphoproliferative disorder.
- •8. History of recurrent (more than one episode) limited herpes zoster or
- •disseminated (a single episode) herpes zoster or herpes simplex. History
- •of disseminated or recurrent infection of EBV or human papilloma virus
- •(HPV) (single, limited episode in the past is not exclusionary)
- •9. Infection requiring hospitalization or parenteral antimicrobial therapy
- •judged clinically significant by the investigator within 6 months prior to
- •first dose of study drug.
- •10. History of an infected joint prosthesis at any time.
- •11. History of recurrent inflammatory joint disease other than RA (eg,
- •post infectious arthritis, gout, etc.) or history of any other autoimmune
- •rheumatic diseases (eg, vasculopathies, spondyloarthropathies, etc.)
- •other than Sjogren's syndrome.
- •12. Evidence of untreated or inadequately treated latent, or inadequately
- •treated or active infection with tuberculosis (TB). Subjects currently
- •receiving treatment for active or latent TB are excluded.
- •13. Chest radiography with evidence of active TB, fungal infections, or
- •other clinically significant abnormalities taken at Screening or within 12
- •weeks prior to first dose of study drug on Day 1.
- •14. Any current or prior treatment for DMARDs within the relevant
- •washout period.
- •15. Current or prior treatment with infliximab or lymphocyte depleting
- •therapies (eg, Rituximab, Campath). Prior exposure to biologic therapy
- •for RA (with the exception of up to 2 doses of one biologic therapy for
- •RA, including anti-TNF therapies(other than infliximab). For prior
- •exposure to a biologic therapy for RA, a washout period of at least 12
- •weeks or 5 half lives(whichever is longer) is required prior to the first
- •dose of study drug.
- •16. Known requirement for treatment with prohibited concomitant
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