None listed
Conditions
Interventions
THE FIRST THREE TREATMENT VISITS WILL OCCUR AT A ONE WEEK INTERVALS. VISIT 4 TO VISIT 6 WILL OCCUR AT A 2 WEEK INTERVALS AND EVERY 6 WEEKS THEREAFTER FOR A TOTAL OF 24 WEEKS.
GIVEN THE ADAPTIVE NAT
18 YEARS OF AGE, WITH AT LEAST 3 MONTHS DIAGNOSIS OF ACTIVE RA MAY BE ENROLLED IN THE STUDY. SUBJECTS MUST HAVE BEEN TREATED WITH MTX FOR AT LEAST 3 MONTHS IMMEDIATELY PRIOR TO SCREENING. SUBJECTS WIL
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. SUBJECT MUST BE ≥ 18 YEARS OF AGE ON THE DAY OF SIGNING THE INFORMED CONSENT. RA DIAGNOSIS AND DISEASE ACTIVITY: 2. SUBJECT HAS A DIAGNOSIS OFRA (ACCORDING TO REVISED 1987 CRITERIA OFTHE ARA) FOR AT LEAST 6 MONTHS PRIOR TO SCREENING. (SEE APPENDIX 6.3) 3. SUBJECT HAS ACTIVE RA AS DEFINED BY THE PRESENCE OF 6 SWOLLEN JOINTS (OF 66 JOINT COUNT) AND 6 TENDER JOINTS (OF 68 JOINT COUNT) AT SCREENING (VISIT 1) AND BASELINE (VISIT 2). 4. SUBJECT HAS A C-REACTIVE PROTEIN (CRP) BLOOD LEVEL > 0.9 MG/DL FROM THE CENTRAL REFERENCE LABORATORY AT SCREENING. (SEE APPENDIX 6.3) 5. SUBJECT IS ANTI-CYCLIC CITRULLINATED ANTIBODY POSITIVE AND/OR RHEUMATOID FACTOR POSITIVE AT SCREENING. (SEE APPENDIX 6.3) 6. SUBJECT IS ACR FUNCTIONAL CLASS I, II, OR III. (SEE APPENDIX 6.4) 7. SUBJECTS HAS RECEIVED MTX FOR A MINIMUM OF 3 MONTHS WITH A REGIONALLY APPROPIATE STABLE WEEKLY DOSE (15-25 MG/WK FOR REGIONS OUTSIDE OF ASIA 6-16 MG/WEEK FOR ASIA) FOR AT LEAST 4 WKS PRIOR TO ENTERING STUDY. DOSE OF WEEKLY METHOTREXATE MUST REMAIN STABLE THROUGH WEEK 24. THE INVESTIGATOR MUST ASSESS THE SUBJECT AS HAVING AN INADEQUATE RESPONSE TO MTX.
Exclusion criteria
Exclusion criteria: 1. SUBJECT HAS INFLAMMATORY DISEASE OTHER THAN RA, INCLUDING BUT NOT LIMITED TO PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, OR LYME DISEASE. 2. SUBJECT HAS SIGNS OR SYMPTOMS OF SEVERE, PROGRESSIVE, OR UNCONTROLLED RENAL, HEPATIC, HEMATOLOGIC, ENDOCRINE, PULMONARY, CARDIAC, NEUROLOGIC, OR CEREBRAL DISEASE, THAT AFFECTS THE SUBJECT´S ABILITY TO PARTICIPATE IN THE TRIAL. 3. SUBJECT HAS BEEN HOSPITALIZED DUE TO AN ACUTE CARDIOVASCULAR EVENT, CARDIOVASCULAR ILLNESS OR CARDIOVASCULAR SURGERY WITHIN 6 MONTHS OF SCREENING. 4. SUBJECT HAS SUSTAINED, UNCONTROILED HYPERTENSION (SYSTOLIC BLOOD PRESSURE OF ≥ 160 MM HG AND/OR DIASTOLIC BLOOD PRESSURE OF ≥ 100 MM HG AT BASELINE), OR UNCONTROLLED DIABETES. 5. SUBJECTS HAS A TRANSPLANTED ORGAN, EXCLUDING CORNEAL TRANSPLANT PERFORMED >3 MONTHS PRIOR TO FIRST DOSE OF TRIAL MEDICATION. 6. SUBJECT HAS HAD A PRIOR MALIGNANCY OR CONCURRENT MALIGNANCY (EXCLUDING SUCCESSFULLY TREATED BASAL CELL CARCINOMA, SQUAMOUS CELL CARCINOMA OF THE SKIN IN SITU, SQUAMOUS CELL CARCINOMA WITH NO EVIDENCE OF RECURRENCE WITHIN 5 YEARS, OR CARCINOMA IN SITU OF THE CERVIX THAT HAS BEEN ADEQUATELY TREATED).
Countries
Canada, Chile, Denmark, Germany, Hungary, Japan, Korea North, Lithuania, Peru, Poland, South Africa, United Kindgdom, United States
Contacts
Public ContactRodolfo Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed