EUCTR2007-002066-35-HU进行中（未招募）不适用
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
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 signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
- •2. Subjects must be at least 18 years of age.
- •3. If the subject is a sexually active woman of childbearing potential, she and any male partner are required to simultaneously use 2 effective contraceptive methods, from the list of effective contraceptives found in Section 4.4
- •4. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an IUD, barrier method with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation, if the woman could become pregnant from the time of the first dose of study medication until completion of follow-up procedures.
- •5. The subject has a diagnosis of RA based upon the American College of
- •Rheumatology (ACR; formerly American Rheumatism Association) 1987 Revised Criteria5, ie, fulfilling at least 4 of the following 7 criteria for at least 6 consecutive months preceding randomization:
- •a. morning stiffness in and around any joint for more than 1 hour;
- •b. soft tissue swelling of 3 or more joint areas;
- •c. swelling of the proximal interphalangeal (PIP), metacarpophalangeal (MCP) or wrist joints;
- •d. symmetrical joint swelling;
- •e. rheumatoid nodules;
- •f. serum rheumatoid factor positive;
- •g. radiographic erosions and/or periarticular osteopenia in hand and/or wrist
- •6. The subject has active disease at both Screening and Baseline, as defined by both:
- •a. =6 joints tender or painful on motion, AND
- •b. =6 joints swollen;
- •and fulfills 1 of the following 2 criteria at Screening:
- •i. Erythrocyte sedimentation rate (ESR) (Westergren method) above the upper limit of normal in the local laboratory
- •ii. C-reactive protein (CRP) >7 mg/L in the central laboratory
- •7. The subject meets ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III (Appendix 1).
- •8. Subjects receiving non-prohibited concomitant medications for any reason must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to first study dose, or as defined in Concomitant Medications (Section 5.5).
- •9. Subjects must have failed an adequate study of therapy with at least 1 DMARD due to lack of efficacy or toxicity. See inclusion criteria 10 and exclusion criteria 1 and 12.
- •10. Subjects having received the following treatment regimens are eligible, provided the following discontinuation periods are observed. Note that none of these therapies should be discontinued by a subject to allow participation in this study if they are currently effective and tolerated.
- •a. Within 4 weeks of first dose of study drug:
- •DMARDS – leflunomide (Arava® ) (see additional washout information for leflunomide in Appendix 10), auranofin (oral gold), injectable gold (aurothioglucose or aurothiomalate), methotrexate, sulfasalazine, and d-penicillamine, minocycline; etanercept (Enbrel®); anakinra (Kineret®);
- •Immunosuppressive/Immunomodulatory therapies -azathioprine,
- •cyclosporine, and PROSORBA® device/column;
- •NSAIDs - any experimental NSAIDs or experimental selective COX-2
- •inhibitors;
- •Other - herbal medications, immunization with any live virus vaccination (eg, FluMist™), intra-articular, intramuscular, or intravenous corticosteroids;
- •b. Within 8 weeks of first dose:
排除标准
- •1. Subjects who discontinued any previous TNFi therapy for either lack of efficacy or adverse events. Subjects who previously received adalimumab therapy for any reason are not allowed in the study.
- •2. Subjects with evidence of hematopoietic disorders:
- •a. Hemoglobin levels <9.0 gm/dL or hematocrit <30% at screening visit or within the 3 months prior to first study dose.
- •b. An absolute white blood cell count of <3.0 x 109/L or absolute neutrophil count of <1.2 X 109/L at screening visit or within the 3 months prior to first study dose.
- •c. Thrombocytopenia, as defined by a platelet count <100 x 109/L at screening visit or within the 3 months prior to first study dose.
- •3. Estimated GFR =50 ml/min based on Cockcroft-Gault calculation.
- •4. Pregnant or lactating women.
- •5. Total bilirubin, AST or ALT more than 2 times the upper limit of normal at screening visit.
- •6. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- •7. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
- •8. Current routine household contact with children who have received varicella or oral polio vaccine within 2 months prior to first study dose, or during the 24 weeks of treatment and for 4 weeks following completion of the study.
- •9. History of any lymphoproliferative disorder, history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
- •10. Evidence of active or latent infection with Mycobacterium tuberculosis, as defined by any of the following:
- •a. A subject has a positive Mantoux Purified Protein Derivative (PPD) skin test result of =5 mm of induration within the 3 months prior to screening, OR
- •b. A subject is immunoreactive for TB using an ex vivo method, OR
- •c. A subject has a chest radiograph that has changes suggestive of active TB infection.
- •11. Subjects with clinically significant infections currently or within 6 months of first dose of study drug (eg, those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), or those with a history of more than one episode of herpes simplex or zoster, a history of disseminated zoster, a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study or any infection requiring antimicrobial therapy within 2 weeks of screening.
- •12. Any prior treatment with lymphocyte-depleting agents/therapies (such as
- •CamPath®[alemtuzab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc). Subjects who have received rituximab or other selective B lymphocyte depleting agents are eligible if they have not received such therapy for at least 1 year prior to first dose (see Appendix 10 for wash out procedure).
- •13. Subjects with any condition possibly affecting oral drug absorption (eg,
- •bariatric/obesity surgery [such as gastric bypass or gastric banding], gastrectomy, or clinically significant diabetic gastroenteropathy).
- •14. History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug.
- •15. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results.
- •16. Donation of blood in excess of 500 mL within 2 months prior to first study dose.
- •17. Subjects
研究者
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