None listed
Conditions
Interventions
APPROXIMATELY 1287 PATIENTS WILL BE SCREENED TO OBTAIN 990 PATIENTS RANDOMIZED 1:1:1 TO ONE OF THE THREE TREATMENT ARMS:
• LY A TREATMENT ARM (n=330): 120 MG LY2127399 Q4W
PATIENTS RECEIVE A 240 MG LOADING DOSE WHEN INITIATING TREATMENT. DURING TREATMENT PERIOD 1, FOR BLINDING PURPOSES, PATIENTS WILL ALTERNATE INJECTIONS OF LY2127399 AND INJECTIONS OF PLACEBO Q2W.
•
PATIENTS RECEIVE A 180 MG LOADING DOSE WHEN INITIATING THE TREATMENT.
• PLACEBO ARM (n=330): Q2W INJECTIONS
PATIENTS RECEIVE TWO INJECTIONS OF PLACEBO WHEN INITIATING TREATMENT.
THERE ARE FOUR PERIODS DURING THIS STUDY (REFER TO FIGURE 1 AND FIGURE 2):
• SCREENING PERIOD (MAXIMAL DURATION OF 28 DAYS
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Australia, Brazil, Bulgaria, Colombia, Croatia, France, Germany, Greece, Hungary, India, Japan, Korea North, Lithuania, Malasya, Mexico, Mozambique, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Ukraine
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed