None listed
Conditions
Interventions
APPROXIMATELY 700 WILL BE SCREENED TO OBTAIN 555 PATIENTS RANDOMIZED 1:1:1 TO ONE OF THREE TREATMENT ARMS:
• LY A TREATMENT ARM (N=185): 120 mg LY2127399 Q4W
PATIENTS RECEIVE A 240 mg LOADING DOSE WHEN INITIATING TREATMENT. DURING THE TREATMENT PERIOD, FOR BLINDING PURPOSES, PATIENTS WILL ALTERNATE INJECTIONS OF LY2127399 AND INJECTIONS OF PLACEBO Q2W.
PATIENTS RECEIVE A 180 mg LOADING DOSE WHEN INITIATING TREATMENT.
• PLACEBO ARM (N=185): Q2W INJECTIONS
PATIENTS RECEIVE TWO INJECTIONS OF PLACEBO WHEN INITIATING TREATMENT.
THERE ARE THREE 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 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, OR B. STOPPED DUE TO INTOLERANCE OF SUCH TREATMENT, REGARDLESS OF TREATMENT DURATION.
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Australia, Brazil, Bulgaria, Colombia, Croatia, France, Germany, Greece, Hungary, India, Japan, Korea North, Lithuania, Malasya, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Ukraine, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed