PER-088-11未知未知
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLED-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LY2127399 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (RA) WHO HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF-α INHIBITORS
ELI LILLY AND COMPANY,0 个研究点目标入组 0 人开始时间: 2012年1月5日最近更新:
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 85（—）
入选标准
- •1. AMBULATORY MALES OR FEMALES ≥ 18 YEARS OF AGE.
- •2. DIAGNOSIS OF ADULT-ONSET RA (OF AT LEAST 6 MONTHSDURATION BUT NOT LONGER THAN 15 YEARS PRIOR TO SCREENING) AS DEFINED BY THE ARA 1987 REVISED CRITERIA FOR THE CLASSIFICATION OF RA (APPENDIX 4).
- •3. HAVE ACTIVE RA DEFINED AS THE PRESENCE OF AT LEAST 8/68 TENEDER AND AT LEAST 8/66 SWOLLEN JOINTS, AS DETERMINED BY THE TENDER JOINT COUNT AND SWOLLEN JOINT COUNTASESSMENT FORMS. (APPENDIX 5).
- •4. HAVE A SCREENING GREATER THAN 1.2 TIMES THE UPPER LIMIT OF NORMAL (ULN) OR A SCREENING ERYTHROCYTE SEDIMENTATION RATE (ESR) GREATER THAN 28 mm/hr. THESE TESTS MAY BE REPEATED ONE TIME DURING THE SCREENING PERIOD AT THE DISCRETION OF THE INVESTIGATOR.
- •5. DOCUMENTED HISTORY OF, OR CURRENT, POSITIVE RF AND/OR ANTI-CCP AB TEST.
- •6. PATIENTS MUST HAVE BEEN TREATED AT APPROVED DOSES WITH AT LEAST ONE BIOLOGIC TNF-α INHIBITOR THERAPY (INFLIXIMAB, CERTOLIZUMAB, GOLIMUMAB, ETANERCEPT, ADALIMUMAB) AND IN THE OPINION OF THE INVESTIGATOR EITHER:
- •A. STOPPED DUE TO INSUFFICIENT EFFICACY, OR LOSS OF EFFICACY, AFTER AT LEAST 90 DAYS OF TREATMENT,
- •B. STOPPED DUE TO INTOLERANCE OF SUCH TREATMENT, REGARDLESS OF TREATMENT DURATION.
排除标准
- •1. USE OF AN UNSTABLE DOSE (ie., REQUIRING DOSE ADJUSTMENT) OF NSAIDs (INCLUDING CYCLOOXYGENASE-2 [COX-2] INHIBITORS) WITHIN 6 WEEKS PRIOR TO BASELINE (VISIT 2).
- •2. USE OF ORAL CORTICOSTEROIDS AT AVERAGE DAILY DOSE OF > 10 mg/day OF PREDNISONE OR ITS EQUIVALENT WITHIN 6 WEEKS PRIOR TO THE BASELINE (VISIT 2).
- •3. HAVE RECEIVED ANY PARENTERAL (INCLUDING INTRAARTICULAR) CORTICOSTEROID INJECTION WITHIN 6 WEEKS OF BASELINE (VISIT 2).
- •4. CONCURRENT OR RECENT USE OF ANY BIOLOGIC DMARD (TNF-α INHIBITOR OR NOT). PATIENTS MUST HAVE STOPPED TNF-α INHIBITORS OR ANAKINRA > 28 DAYS; TOCILIZUMAB > 56 DAYS; ABATACEPT > 90 DAYS; RITUXIMAB OR ANY OTHER B CELL BIOTHERAPY > 1 YEAR, OR ANY OTHER BIOLOGICAL DMARD > 5 HALF- LIVES PRIOR TO BASELINE.
- •5. HAVE RECEIVED AN ORAL CALCINEURIN INHIBITOR (eg., CYCLOSPORIN OR TACROLIMUS) AT ANYTIME WITHIN 8 WEEKS OF BASELINE (VISIT 2) OR ANY PREVIOUS TREATMENT WITH ALKYLATING AGENTS SUCH AS CYCLOPHOSPHAMIDE OR CHLORAMBUCIL.
- •6. HAVE SUFFERED A SEVERE REACTION TO ANY BIOLOGICAL TREATMENT THAT, IN OPINION OF THE RESEARCHER, WILL MEANS AN UNACCEPTABLE RISK FOR THE PATIENT IF WILL BE PARTICIPATING IN THE STUDY.
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