A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-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 METHOTREXATE THERAPY

ELI LILLY AND COMPANY,0 个研究点目标入组 0 人开始时间: 2011年8月10日最近更新: 2023年9月4日

试验速览

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•1. AMBULATORY MALES OR FEMALES ≥ 18 YEARS OF AGE.
•2. DIAGNOSIS OF ADULT-ONSET RA (OF AT LEAST 6 MONTHS DURATION 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 TENDER AND AT LEAST 8/66 SWOLLEN JOINTS, AS DETERMINED BY THE TENDER JOINT COUNT AND SWOLLEN JOINT COUNT ASSESSMENT FORMS. (APPENDIX 5).
•4. HAVE A SCREENING CRP 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. REGULAR USE OF MTX FOR AT LEAST 12 WEEKS AND STABLE DOSE (10 TO 25 MG/WEEK) FOR AT LEAST 8 WEEKS PRIOR TO BASELINE. LOCAL STANDARD OF CARE (SoC) SHOULD BE FOLLOWED FOR CONCOMITANT ADMINISTRATION OF FOLIC ACID. IF ON HYDROXYCHLOROQUINE AND/OR SULFASALAZINE IN ADDITION TO MTX, SHOULD HAVE BEEN GETTING A DOSE STABLE AND MUST HAVE BEEN ON A STABLE DOSE AND SHOULD NOT BE ADJUSTED FOR AT LEAST 8 WEEKS PRIOR TO BASELINE.

•1. USE OF AN UNSTABLE DOSE (i.e, 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 BASELINE (VISIT 2).
•3. HAVE RECEIVED ANY PARENTERAL (INCLUDING INTRAARTICULAR) CORTICOSTEROID INJECTION WITHIN 6 WEEKS OF BASELINE (VISIT 2).
•4. HAVE RECEIVED ANY BIOLOGICAL DMARD IN THE PAST AND HAVE STOPPED DUE TO INSUFFICIENT EFFICACY. PATIENTS MUST HAVE STOPPED ANAKINRA >7 DAYS, ETANERCEPT >28 DAYS, INFLIXIMAB, TOCILIZUMAB, OR ADALIMUMAB >56 DAYS, ABATACEPT >90 DAYS; OR ANY OTHER BIOLOGIC DMARD >5 HALF-LIVES PRIOR TO BASELINE (VISIT 2).
•5. HAVE PREVIOUSLY RECEIVED RITUXIMAB OR ANY OTHER B CELL TARGERED BIOTHERAPY.
•6. HAVE HAD A SEVERE REACTION TO ANY BIOLOGIC THERAPY THAT IN THE OPINION OF WOULD POSE AN UNACCEPTABLE RISK TO THE PATIENT IF PARTICIPATING IN THE STUDY.
•7. HAVE HAD AN INADEQUATE RESPONSE TO TREATMENT, BASED ON THE CLINICAL JUDGMENT OF THE TREATING PHYSICIAN OR INVESTIGATOR, WITH 3 OR MORE OF THE FOLLOWING DMARDS PRESCRBED ALONE OR IN COMBINATION AT APPROVED DOSES FOR A MINIMUM OF 90 DAYS: LEFLUNOMIDE, AZATHIOPRINE, CYCLOSPORINE AND SULFASALAZINE.

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