EUCTR2011-003668-55-CZ进行中（未招募）1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDYOF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB (CP-690,550)OR ADALIMUMAB IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS.Paediatric investigation plan numbers - (P/144/2010),(P/162/2011) and(P/0064/2012). - OPAL Broaden
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
- 400
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •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.The subject has signs and symptoms consistent with the diagnosis of PsA for at least 6 months and fulfills CASPAR Criteria17 at screening and has evidence of active arthritis based upon number of tender/painful and swollen joints.
- •4. Ongoing treatment with a stable dose of traditional non-biologic DMARDs (eg, methotrexate, sulfasalazine or leflunomide) (Background DMARDs section, as per protocol).
- •5. Meet all other eligibility criteria described in Sections A3921091 Specific PsA Patient Population, and the Other Inclusion Criteria section, in the Protocol.
- •6. Must have inadequate response to a traditional oral non-biologic DMARD.
- •7. Must be naive to tumour-necrosis factor inhibitor.
- •Please see the Protocol for the full list of the inclusion criteria.
- •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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Currently have non plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis, which is allowed.
- •2. Subjects who are investigational site staff members directly involved in the conduct of the trial 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 trial.
- •3. Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks before the current study begins and/or during study participation. Participation in any observational studies during study participation.
- •4. Pregnant females, breastfeeding females, females of child bearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least one ovulatory cycle after last dose of investigational product or females planning pregnancy. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study. (Further description of the requirements and a list of contraceptives considered highly effective and acceptable for use in this study).
- •5. Current or recent history of a severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholersterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.
- •6. Blood dyscrasias within 3 months prior to the first dose of study drug including confirmed:
- •a. Hemoglobin <10 g/dL;
- •b. White blood cell count <3.0 x 10x9/L (<3000/mm3);
- •c. Absolute neutrophil count =1.5 x 10x9/L(<1500/mm3);
- •d. Absolute lymphocyte count <1.0x10x9/L (<1000/mm3)
- •e. Platelet count <100 x 10x9/L (<100,000/mm3).
- •7. Estimated Creatinine Clearance <40 ml/min based on Cockcroft Gault equation (see Appendix 2).
- •8. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit.
- •9. Have a known immunodeficiency or a first degree relative with a hereditary immunodefiency.
- •10. Also excluded are subjects with history of any autoimmune rheumatic disease other than PsA (including systemic lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or known diagnosis of fibromyalgia, without approval by Sponsor. Prior history of, or current rheumatic inflammatory disease other than PsA (eg, gout, reactive arthritis, chronic Lyme disease) without approval by Sponsor.
- •11. Functional Class IV as defined by the American College of Rheumatology classification of functional status for RA, ie, limited in ability to perform usual self care, vocational and avocational activities.
- •12. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
- •13. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
- •14. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
- •15. History of infection requiring:
- •Hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study medication.
- •Oral antimicrobial therapy within 2 weeks prior to the fi
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