EUCTR2014-000358-13-HR进行中（未招募）1 期
A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 个研究点目标入组 1,146 人开始时间: 2015年11月10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
- 1,146
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 legally acceptable representative) has been informed of all pertinent aspects of the study.
- •2. Must be at least 18 years of age or older.
- •3. Specific criterion for administration of the zoster vaccine - details contained in the Protocol
- •4. Has =4 tender/painful joints on motion and =4 swollen joints (28 joint count) at Screening and Baseline/Visit 2
- •5. Screening C-reactive protein (CRP) =3 mg/L in the central laboratory
- •6. Has moderate to severe rheumatoid arthritis inadequately controlled with methotrexate
- •7. Has a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis (Appendix 1 of Protocol)
- •8. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA where usual self-care activities including dressing, feeding, bathing, grooming, and toileting; avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities are subject-desired and age- and sex-specific. (Details re Class I, II, III contained in the Protocol)
- •9. Has been receiving a MTX treatment regimen continuously for at least 4 months prior to the Screening visit and has taken a stable weekly dose of oral methotrexate with supplemental folic or folinic acid for at least 6 weeks prior to the Baseline/Visit 2. (Conversion from parenteral to oral will require stabilization” over this period of time as well). (Further details contained in the Protocol).
- •10. Female subjects of childbearing potential must test negative for pregnancy.
- •11. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for at least 3 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. (Please refer to Appendix 6 for specific requirements for subjects enrolled in Croatia, Czech Republic, Estonia, Germany, Hungary, Lithuania, Latvia, Romania, Spain and the United Kingdom).
- •12. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
- •a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •b. Have medically confirmed ovarian failure or;
- •c. Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females
- •13. Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent) as evidenced by the following:
- •a. Negative QuantiFERON Gold®TM In-Tube test performed at screening
- •- This is required unless the subject has been adequately treated for active or latent tuberculosis or a negative QuantiFERON Gold®TM In-Tube test was
- •previously performed and documented within the 3 months prior to screening.
- •- A negative tuberculin skin test (TST) is one that is <5 mm induration and can be substituted for the QuantiFERON Gold ® TM In-Tube test only if the
- •central laboratory is unable to perform the test or the test is reported as indeterminate after at
排除标准
- •1. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
- •2. Subjects who have an allergy or hypersensitivity to MTX, subjects who have experienced a serious toxicity when administered MTX, or have any contraindication to treatment with MTX according to the local label for treatment of RA with MTX.
- •3. Subjects who have Class III or Class IV heart failure according to the New York Heart Association (NYHA) functional classification system or any other contraindication to treatment with adalimumab.
- •4. Pregnant female subjects; breastfeeding female subjects; males and females of childbearing potential who are unwilling or unable to use two methods of highly effective contraception as outlined in this protocol for the duration of the study and for at least 3 months after last dose of investigational product. (Please refer to Appendix 6 for specific requirements for subjects enrolled in Croatia, Czech Republic, Estonia, Germany, Hungary, Lithuania, Latvia, Romania, Spain and the United Kingdom).
- •5. Subjects with infections or history of infections (additional details in Protocol) .
- •6. Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •7. Subjects with any uncontrolled clinically significant laboratory abnormality or any of the following laboratory abnormalities:
- •a. Evidence of hematopoietic disorder or hemoglobin <9 g/dL
- •b. Absolute lymphocyte count <0.75 x 10^9/L (<750/mm3)
- •c. Absolute neutrophil count <1.2 x 10^9/L (<1200/mm3)
- •d. Platelet count <100 x 10^9/L (<100,000/mm3)
- •e. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (x ULN)
- •f. Estimated glomerular filtration rate (GFR) <40 mL/min using the Cockcroft-Gault formula (Appendix 3 of Protocol).
- •8. Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation, unless further restrictions to class of compound are specified in Section 4.2 and Section 5.8.
- •9. Subjects requiring or have received any prohibited concomitant medication or dietary supplement as outlined in Appendix 2 of the Protocol.
- •10. Subjects with a screening 12-lead electrocardiogram that demonstrates clinically significant abnormalities requiring urgent treatment (eg, acute myocardial infarction, serious tachy- or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads).
- •11. Subjects who had significant trauma or surgical procedure within 1 month prior to the Baseline/Visit 2.
- •12. Subjects with any rheumatic autoimmune disease, other than RA and Sjogren’s syndrome.
- •13. Subjects who are classified Class IV of the ACR 1991 Revised Criteria for Global Functional Status in RA (ie, are limited in their ability to perform usual self-care, vocational, and avocational activities).
- •14. Subjects with lymphoproliferative disorders (eg, Epstein Barr Virus (EBV) related lymphoproliferative disorder), a history of ly
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisModerately to severely active Rheumatoid ArthritisMedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-000358-13-BGPfizer Inc. 235 East 42nd Street, New York, NY 100171,080
进行中（未招募）
1 期
A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisModerately to severely active Rheumatoid ArthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-000358-13-ROPfizer Inc. 235 East 42nd Street, New York, NY 100171,146
进行中（未招募）
1 期
A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisModerately to severely active Rheumatoid ArthritisMedDRA version: 19.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-000358-13-PLPfizer Inc., 235 East 42nd Street, New York, NY 100171,080
进行中（未招募）
1 期
A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisModerately to severely active Rheumatoid ArthritisMedDRA version: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-000358-13-GBPfizer Inc. 235 East 42nd Street, New York, NY 100171,080
进行中（未招募）
1 期
A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritisModerately to severely active Rheumatoid ArthritisMedDRA version: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-000358-13-LVPfizer Inc. 235 East 42nd Street, New York, NY 100171,080