A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF JTE-051 ADMINISTERED FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (MOVE-RA)
- Conditions
- -M05M05
- Registration Number
- PER-046-15
- Lead Sponsor
- Akros Pharma Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 61
**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.
**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 <3.0 x 109/L, absolute neutrophil count of <1.5 x 109/L or absolute lymphocyte count <0.8 x 109/ 4. Hemoglobin <9 g/dL or platelet count <100,000/mm3
5. ALT >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method