None listed
Conditions
Interventions
SUBJECT WHO COMPLETED THE FIRST 24 WEEKS WILL BE EVALUATED OVER A 24 WEEK EXTENSION PERIOD (TOTAL OF 48 WEEKS). FOR ETHICAL REASONS, SUBJECTS IN THE PLACEBO WITH MTX ARM WILL BEGIN TO RECEIVE BMS-9454
SCREENING PROCEDURES SCHEDULED AT OTHER OFFICES) TO ALLOW CLOSE CONTROL OVER THE FINAL NUMBER OF RANDOMIZED SUBJECTS.
UPON OBTAINING THE INFORMED CONSENT, A SUBJECT´S ELIGIBILITY WILL BE DETERMINED
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT A) SUBJECT IS WILLING TO PARTICIPATE IN THE STUDY AND HAS SIGNED INFORMED CONSENT. 2) TARGET POPULATION A) MEN AND WOMEN, AGES ≥ 18 YEARS. B) SUBJECTS HAVE A DOCUMENTED DIAGNOSIS OF ACTIVE RA BY STANDARD CRITERIA (ARA [1987] OR ACR/EULAR [2010]) AT LEAST 16 WEEK PRIOR TO SCREENING (SEE APPENDIX 1 O 2). C) SUBJECTS HAVE AN ACR GLOBAL FUNCTIONAL STATUS CLASS OF 1 TO 3. (SEE APPENDIX 3). D) SUBJECTS MUST BE MTX INADEQUATE RESPONDERS. SUBJECTS MUST HAVE BEEN TAKING MTX FOR AT LEAST 3 MONTHS AT A MINIMAL WEEKLY DOSE OF 15 MG, AND AT A STABLE DOSE FOR 4 WEEKS PRIOR TO RANDOMIZATION (DAY 1). i) A MTX WEEKLY DOSE AS LOW AS 10 MG IS ONLY PERMITTED IF THERE IS VERIFIABLE DOCUMENTATION IN THE MEDICAL RECORD PRIOR TO ENTRY INTO THE STUDY THAT THE SUBJECT DID NOT RESPOND TO AT LEAST 15 MG OR HIGHER DOSE AND THE DOSE IS REDUCED FOR TOXICITY/INTOLERABILITY. E) SUBJECTS HAVE A MINIMUM OF 6 SWOLLEN AND 6 TENDER JOINTS ON A 66/68 JOINT COUNT ON SCREENING VISIT 1 FOR THOSE NOT REQUIRING WASHOUT AND ON SCREENING VISIT 2 FOR THOSE REQUIRING WASHOUT.
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE A) SUBJECTS WITH DOCUMENTED JUVENILE RHEUMATOID ARTHRITIS. B) SUBJECT WHO HAVE PREVIOUSLY RECEIVED OR ARE CURRENTLY RECEIVING AN APPROVED BIOLOGIC THERAPY FOR RA (THE ELIGIBILITY OF OTHER BIOLOGIC THERAPIES INCLUDING EXPERIMENTAL THERAPIES SHOULD BE DISCUSSED WITH THE BMS MEDICAL MONITOR). C) SUBJECTS WHO HAVE BEEN TREATED WITH LEFLUNOMIDE WITHIN 1 YEAR PRIOR TO SCREENING. D) SUBJECTS WHO ARE CURRENTLY RECEIVING CALCINEURIN INHIBITORS. E) SUBJECTS WHO ARE CURRENTLY RECEIVING NIMESULIDE. F) SUBJECT USING PARENTERAL MTX FOR ADMINISTRATION OF THEIR WEEKLY DOSE. G)SUBJECTS WHO HAVE BEEN TREATED WITH IM OR IA GLUCOCORTICOSTEROIDS WITHIN 4 WEEKS OF RANDOMIZATION (DAY 1). 2) MEDICAL HISTORY AND CONCURRENT DISEASES A) SUBJECTS AT RISK FOR TUBERCULOSIS. SPECIFICALLY, SUBJECT WITH: i) CURRENT CLINICAL, RADIOGRAPHIC OR LABORATORY EVIDENCE OF ACTIVE TB. ii) A HISTORY OF ACTIVE TB WITHIN THE LAST 3 YEARS EVEN IF IT WAS TREATED. iii) A HISTORY OF ACTIVE TB GREATER THAN 3 YEARS AGO UNLESS THERE IS DOCUMENTATION THAT THE PRIOR ANTI-TB TREATMENT WAS APPROPIATE IN DURATION AND TYPE. B) LATENT TB WHICH HAS NOT BEEN SUCCESSFULLY TREATED.
Countries
Argentina, Australia, Canada, Czech Republic, France, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, South Africa, Spain, United States
Contacts
Public ContactLarissa Silva
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed