None listed
Conditions
Interventions
JTE-051 tables of 25 mg or 50 mg strength and matching placebo to be administered orally.
Patients will received 4 tablets per day allowing the following total daily dose (each corresponding to one
Sponsors
Akros Pharma Inc.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: **Please refer to the study protocol for the full list and detailed description of the selection criteria. 1. Males and females, 18 to 75 years of age at Visit 1 2. A diagnosis of RA prior to the Screening Visit, based on Classification Criteria 3. Active disease despite ongoing therapy with up to 2 non-biologic DMARDs, including MTX at both the Screening and Baseline Visits 4. Screening hs-CRP >1.2 x ULN 5. Background treatment with up to 2 non-biologic DMARDs, including MTX (mandatory) and one of the following medications : sulfasalazine, hydroxychloroquine or chloroquine 6. Body Mass Index (BMI): 18 to 40 kg/m2 7. Females must comply with the following: Be surgically sterile, post-menopausal, or of childbearing potential and are compliant with at least 2 acceptable forms of birth control for the duration of the study and for at least 12 weeks after the last dose of study drug. 8. Males with female partners of childbearing potential must agree to practice total abstinence or use a barrier contraceptive method with spermicide for the duration of the study and for at least 12 weeks after the last dose of study drug. Female partners of male subjects randomized in this study must be surgically sterile, postmenopausal, or use an acceptable form of birth control 9. Able and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: **Please refer to the study protocol for the full list and detailed description of the selection criteria. 1. Prior/current exposure to biologic and/or kinase inhibitor therapy; 2. Does not meet all study restrictions 3. White blood cell count of 1.2 x the ULN; AST >1.2 x the ULN or Total Bilirubin >1.5 x the ULN6. Renal impairment or eGFR ≤60 mL/min 7. Serum triglycerides >400 mg/dL 8. Positive viral serology: • HIV • Hepatitis B virus • Hepatitis C virus 9. Positive drug of abuse and alcohol test results 10. Abuse, drug addiction or alcoholism 11. Positive Purified Protein Derivative or quantiFERON®-TB Gold-In-Tube test , positive chest radiography findings for tuberculosis 12. Live vaccination 13. Have donated or received any blood or blood products 14. History of a clinically-significant infection 15. infection requiring hospitalization or parenteral antibiotic, antiviral, antifungal, or antiparasitic therapy 16. Herpes zoster; 17. History of acute inflammatory joint disease of an origin other than RA or subject has any other rheumatic disease other than RA18. Any lymphoproliferative disorder19. Malignancies 20. Organ transplantation; 21. Acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, cerebrovascular accident or transient ischemic attack
Countries
Argentina, Bulgaria, Colombia, Mexico, Peru, Poland, Romania, Russian Federation, Ukraine, United States
Contacts
Public ContactJuanita Aching
PPD Peru S.A.C.
Outcome results
None listed