None listed
Conditions
Interventions
AFTER SCREENING, PATIENTS WILL BE STRATIFIED BY STEROID DOSE AT ENTRY TO EITHER A LOW (0 TO ≥
5 MG PREDNISONE OR EQUIVALENT) OR HIGH (> 5 TO 10 MG) DOSE GROUP, TO BE ALLOCATED EQUALLY ACROSS TREATMENT GROUPS. PATIENTS RECEIVING A STEROID DOSE > 10 MG WILL BE EXCLUDED FROM PARTICIPATING IN THIS
Sponsors
Worldwide Clinical Trials Peru SRL,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.HAVE VOLUNTARILY SIGNED THE INFORMED CONSENT FORM. 2.BE AT LEAST 18 YEARS OF AGE. 3.MEET THE ACR/EULAR CRITERIA FOR CLASSIFICATION OF RA (PLEASE REFER TO SECTION 5.13.2 AND/OR APPENDIX B [SECTION 12.2] FOR ADDITIONAL DETAILS) WHICH INCLUDE: .JOINT INVOLVEMENT .SEROLOGY .ACUTE-PHASE REACTANTS .DURATION OF SYMPTOMS 4.HAVE MODERATE TO SEVERE RA, DEFINED AS INVOLVING A MINIMUM (≥6 TOTAL SWOLLEN AND ≥6 TOTAL TENDER) OF THE 28 JOINTS ASSESSED. 5.HAVE SCREENING CRP LEVELS OF AT LEAST 0.6 MG/DL AND A DAS28-CRP SCORE ≥4.5. 6.HAVE BEEN ON A STABLE DOSE OF CONVENTIONAL DMARD THERAPY FOR AT LEAST 90 DAYS WITHOUT DOSAGE ADJUSTMENT OR MODIFICATION AND SHOULD BE ABLE TO MAINTAIN THE SAME DOSE OF CONVENTIONAL DMARD THERAPY DURING STUDY PARTICIPATION (WITH OR WITHOUT GLUCOCORTICOID THERAPY). STABLE DMARD THERAPY MAY INCLUDE A COMBINATION OF DMARD AGENTS (METHOTREXATE AND AZSULFADINE OR METHOTREXATE AND HYDROXYCHLOROQUINE AS EXAMPLES). 7.FEMALE PATIENTS OF CHILDBEARING POTENTIAL (18 TO 55 YEARS OF AGE, INCLUSIVE) MUST HAVE NEGATIVE URINARY BHCG TESTS AT ENROLLMENT AND STUDY COMPLETION. 8. FEMALE PATIENTS OF CHILDBEARING POTENTIAL (18 TO 55 YEARS OF AGE, INCLUSIVE) MUST USE ACCEPTABLE METHODS OF BIRTH CONTROL (INCLUDING, BUT NOT LIMITED TO, IUD, ORAL OR INJECTABLE CONTRACEPTIVES, OR BARRIER METHODS) WHILE IN THE STUDY. 9. IF CURRENTLY TAKING A STATIN SHE/HE HAS BEEN ON A STABLE DOSE OF THE SAME STATIN FOR AT LEAST 3 MONTHS PRIOR TO ENTERING INTO THE TRIAL AND
Exclusion criteria
Exclusion criteria: 1.FEMALE PATIENT IS PREGNANT OR LACTATING OR OF CHILD BEARING POTENTIAL NOT USING ACCEPTABLE METHODS OF BIRTH CONTROL (INCLUDING, BUT NOT LIMITED TO, IUD, ORAL OR INJECTABLE CONTRACEPTIVES, BARRIER METHODS, OR ABSTINENCE). 2.TREATMENT-REFRACTORY PATIENT ARE EXCLUDED. TREATMENT-REFRACTORY PATIENTS HAVE FAILED TO BENEFIT FROM THERAPY WHICH IS DEFINED BY TREATMENT WITH MULTIPLE DMARDS OR TREATMENT WITH DMARDS PLUS A BIOLOGIC FOR A MINIMUM OF 30 DAYS. 3.HAS ACTIVE CARDIOVASCULAR DISEASE, UNLESS WELL CONTROLLED BY APPROPRIATE TREATMENT FOR A MINIMUM OF 3 MONTHS PRIOR TO SCREENING. 4.IS TAKING ASPIRIN FOR REASON OTHER THAN FOR CARDIOVASCULAR PROPHYLAXIS OR THEIR TOTAL DAILY DOSE IS GREATER THAN 325 MG. 5.IS CURRENTLY TAKING STEROIDS AT A DAILY PREDNISONE DOSE, OR THE EQUIVALENT, OF > 10 MG. 6.INTRAARTICULAR, INTRAMUSCULAR, OR INTRAVENOUS GLUCOCORTICOIDS MUST NOT HAVE BEEN GIVEN AT LEAST 6 WEEKS PRIOR TO ENTERING THE STUDY. 7.THE NEED TO CONTINUE THE USE OF ONE OR MULTIPLE NSAID´S AT THE SAME, OR THE USE OF ACETAMINOPHEN ON A CHRONIC BASIS. ACETAMINOPHEN/PARECETAMOL WILL BE PERMITTED EPISODICALLY FOR PAIN DURING THE TRIAL, NOT TO EXCEED 1.5 GRAMS PER DAY FOR ANY 3 DAYS IN ANY 7 DAY INTERVAL. THERE ARE NO EXCLUSIONS DURING THE 30 DAY FOLLOW-UP PERIOD. 8. ALL OPIATE USE IS PROHIBITED. SUCH AGENTS INCLUDE OXYCODONE, HYDROCODONE, CODEINE, MORPHINE SULFATE, DEMEROL (MEPERIDINE), DILAUDID (HYDROMORPHONR), COMBINATION PRODUCTS INCLUDING PERCOCET (OXYCODONE AND ACETAMINOPHEN),
Countries
United States
Contacts
Public ContactNancy Mercedes Liendo
WorldWide Clinical Trials Peru S.R.L. -W.C.T. Peru S.R.L.
Outcome results
None listed