EUCTR2008-000170-20-ES进行中（未招募）1 期
A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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) Subjects must be able to provide informed, written consent.
- •2) Target Population
- •a) Subjects must meet the criteria of the American Rheumatism Association (1987)
- •for the diagnosis of RA (Arnett et al, 1988) (Appendix 3). The disease must have
- •been diagnosed for = 6 months prior to screening.
- •b) Subjects must have been taking MTX for at least 3 months at a weekly dose of 7.5
- •to 30 mg, inclusive, and at a stable dose for 28 days prior to treatment (Day 1).
- •Use of parenteral MTX is acceptable as clinically indicated if subjects cannot
- •tolerate or absorb oral MTX.
- •c) Subjects must be MTX inadequate responders defined as currently having 6 or
- •more swollen joints and 8 or more tender joints at the screening visit (refer to
- •Inclusion number 5, disease activity)
- •3) Age and Sex
- •a) Men and women at least 18 years of age. Men and women of childbearing
- •potential are eligible if they are practicing effective contraceptive measures.
- •Because subjects are taking background therapy such as methotrexate for
- •treatment of RA, which has potential risks associated with its use in pregnancy,
- •subjects will be re-advised on the use of reliable contraceptive methods and on the
- •potential risks to a pregnancy.
- •Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 4 weeks after
- •the last dose of investigational product in such a manner that the risk of pregnancy
- •is minimized.
- •4) Concomitant Medication (Anti-rheumatic Treatment)
- •a) MTX alone: Subjects who are treated only with methotrexate will not require
- •b) MTX plus DMARDs other than sulfasalazine or anti-malarials (eg
- •hydoxychloroquine, chloroquine): Subjects who are treated with MTX in
- •combination with another anti-rheumatic treatment (DMARD) will require
- •washout of the other DMARDs.
- •c) Drug stabilization requirements
- •i) If subjects are taking sulfasalazine and/or anti-malarials, which are allowed as
- •concomitant therapy in this study, they must be on a stable dose for 25 out of
- •28 days prior to treatment (Day 1).
- •ii) All DMARDs (except MTX, sulfasalazine and anti-malarials) must be
- •discontinued at least 28 days prior to treatment (Day 1). In the case of
- •leflunamide, the subject can be washed out with cholestyramine according to
- •manufacturers recommendations.
- •iii) Oral corticosteroid treatment must have been reduced to = 10 mg prednisone
- •or equivalent per day for at least 14 days and stabilized for at least 11 out of
- •14 days prior treatment (Day 1).
- •iv) Subjects who have had previous treatment with any
- •biologic/immunosuppresant therapy for RA require wash-out for a period of at
- •least 28 days or 5 half lives whichever is longer or a minimum of 3 months for
- •any biologic agent with an unknown half life, prior to treatment (Day 1).
- •v) Subjects requiring NSAIDs must be on a stable dose for at least 14 days prior
- •to Day 1 dose.
- •d) Prior treatment with up to two anti-TNFa inhibitors will be allowed.
- •5) Disease Activity
- •a) For subjects receiving MTX alone or MTX plus sulfasalizine and/or antimalarials:
- 另有 7 项未显示
排除标准
- •1) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 4 weeks after the last dose of
- •investigational product.
- •b) Women who are pregnant or breastfeeding
- •c) Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration.
- •d) Men who are unwilling or unable to use an acceptable method of birth control
- •for the entire study period.
- •2) Medical History and Concurrent Diseases
- •a) Any clinically significant acute or chronic illness other than RA that is severe,
- •progressive or uncontrolled at the time of screening. This includes any current
- •signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
- •hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
- •musculoskeletal, genitourinary, or thyroid disease.
- •b) Any major surgery within 4 weeks of screening or planned/scheduled surgery
- •requiring hospitalization during the time of the study.
- •c) Blood transfusion within 4 weeks of screening.
- •d) Donation of blood or plasma to a blood bank or in a clinical study within 4 weeks of screening.
- •e) Any condition that could impact upon the absorption of study drug. (ie, gastric
- •ulcer requiring therapy, gastric stapling, duodenal surgery, malabsorption syndrome).
- •f) Subjects (currently or within 3 months) requiring chronic or intermittent medical
- •therapy or surgical intervention for gastrointestinal disease including
- •gastrointestinal ulceration, chronic heartburn, esophageal reflux, gastric or
- •duodenal ulcer and/or gastritis.
- •g) Any infection requiring systemic anti-microbial treatment that completed within 4
- •weeks of enrollment.
- •h) Major infection requiring hospitalization or receipt of intravenous antibiotics
- •within 2 months prior to enrollment.
- •i) Subjects at risk for tuberculosis (TB).
- •j) Have a history of opportunistic infection and/or evidence of active infection
- •including but not limited to HIV, Hepatitis B or C viruses.
- •k) History of lymphoproliferative disease, including lymphoma, or signs suggestive
- •of possible lymphoproliferative disease, such as lymphadenopathy of unusual
- •size, location, or clinically significant splenomegaly.
- •l) Any known malignancy or history of malignancy within 5 years including
- •carcinoma in situ prior to enrollment, with the exception of basal cell or
- •squamous cell carcinoma of the skin that has been excised with no evidence of
- •recurrence (squamous cell carcinoma of other location is exclusionary).
- •m) Subjects who have received treatment with any investigational drug within the
- •previous 30 days or 5 half-lives of the Day 1 dose, whichever is greater.
- •n) Subjects who have received a live vaccine within 3 months of Day 1 dosing.
- •3) Physical and Laboratory Test Findings
- •a) Subjects at screening with PT and/or aPTT and/or INR values = 1.05 X ULN.
- •b) Subjects at screening with ALT or AST elevations = 1.5 X ULN or with a history
- •of frequent or recent ALT or AST elevations are excluded.
- •c) Subjects at screening with CK elevations = 2 X ULN or with a history of frequent
- •or recent CK elevations are excluded.
- •d) Any clinically significant (as determined by the investigator) vital signs and/or physical examination finding.
- •e) Positive blood screen for hepatitis B surface Ag and hepatitis C antibody.
- 另有 3 项未显示
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