None listed
Conditions
Interventions
A SELECTION PERIOD (SCR) of 4 WEEKS WILL BE USED PRIOR TO RANDOMIZATION TO EVALUATE THE ELIGIBILITY FOLLOWED BY A PERIOD OF 2 YEARS TREATMENT.
IN THE BEGINNING (BSL) PATIENTS WHOSE ELIGIBILITY IS C
20% IMPROVED FROM BASELINE IN COUNTS OF SWOLLEN AND TENDER JOINTS) OR NOT RESPONDING AND BE REASSIGNED / RE-RANDOMIZED IN WEEK 16 IN THE TRL FOR DOUBLE BLIND TREATMENT UNTIL 2 YEARS, IN THE FOLLOWING
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT MUST BE ABLE TO UNDERSTAND AND COMMUNICATE WITH THE INVESTIGATOR AND MEET THE REQUIREMENTS OF THE STUDY AND INFORMED CONSENT TO GIVE A WRITTEN, SIGNED AND DATED BEFORE ANY ASSESSMENT STUDY 2. PATIENTS NOT PREGNANT MEN OR WOMEN, INFANTS NOT AT LEAST 18 YEARS 3. AR CLASSIFIED BY PRESENCE OF REVISED CRITERIA ACR 2010 (SEE APPENDIX 2) FOR AT LEAST 3 MONTHS BEFORE THE SELECTION 4. IN THE BASELINE EVALUATION CRITERIA OF DISEASE ACTIVITY DEFINED ≥ 6 SENSITIVE JOINTS 68 and ≥ 6 SWOLLEN JOINTS OF 66 WITH AT LEAST 1 OF THE FOLLOWING IN THE SELECTION: • ANTI-CCP POSITIVE OR • POSITIVE RHEUMATOID FACTOR AND WITH AT LEAST 1 OF THE FOLLOWING IN THE SELECTION: • PCRhs ≥ 10 mg / l O • VSE ≥ 28 mm/1era. time 5. PATIENTS SHOULD HAVE BEEN GETTING AT LEAST AN AGENT ANTI-TNF-α CORNO ETANERCEPT, ADALIMUMAB, INFLIXIMAB, CERTOLIZUMAB OR ADMINISTERED TO A DOSE GOLIMUMAB APPROVED FOR AT LEAST 3 MONTHS BEFORE AND HAVE EXPERIENCED RANDOMIZATION INADEQUATE RESPONSE TO TREATMENT OR INTOLERANCE AT LEAST ONE MANAGEMENT AGENT ANTI-TNF-α
Exclusion criteria
Exclusion criteria: 1. CHEST X-RAY EVIDENCE OF INFECTIOUS PROCESS WITH OR EVIL IN PROGRESS, OBTAINED WITHIN 3 MONTHS OF THE SELECTION AND EVALUATED BY A QUALIFIED PHYSICIAN 2. AR PATIENTS WITH CLASS IV FUNCTIONAL STATUS IN ACCORDANCE WITH ACR 1991 REVISED CRITERIA (SEE APPENDIX 3) 3. OPIATES PAIN PATIENTS RECEIVING HIGH POWER (FOR EXAMPLE, METHADONE, MORPHINE HYDROMORPHONE O) 4. PRE-EXPOSURE SECUKINUMAB BIOLOGICAL OR OTHER DRUG HEADED DIRECTLY OR IL-17 RECEPTOR IL-1 7 5. ANY USE OF DRUG AND / OR THE RESEARCH WITHIN 4 WEEKS OF RANDOMIZATION, OR A PERIOD OF 5 HALF LIVES OF DRUG RESEARCH, WHICHEVER IS LONGER. 6. BACKGROUND OF HYPERSENSITIVITY TO STUDY DRUG OR DRUG CLASS EXCIPIENTS CHEMICAL OR SIMILAR. 7. INTRAARTICULAR ANY THERAPY (EG STEROIDS, HYALURONAN) REQUIRED FOR THE TREATMENT OF ARTHRITIS IN 4 WEEKS BEFORE THE RANDOMIZATION. 8. INTRAMUSCULAR STEROID INJECTION ANY WITHIN 2 WEEKS BEFORE RANDOMIZATION 9. PATIENTS WHO HAVE RECEIVED EVER IMMUNOMODULATING BIOLOGICAL AGENTS TARGETING EXCEPT TNFα
Countries
Belgium, Canada, Colombia, Guatemala, Hungary, Italy, Japan, Panama, Puerto Rico, Romania, Thailand, Turkey, United Kindgdom, United States
Contacts
Public ContactAlexandra Lopez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed