Reumatoidalne zapalenie stawów: badanie fazy II leku AP1189

Kryteria wyłączenia kto nie może wziąć udziału (23)

1. Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.
2. Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.
3. Current inflammatory joint disease other than RA.
4. Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and/or severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.
5. Gastrointestinal diseases known to interfere with the absorption or excretion of medications.
6. Severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
7. Malignancy active during the 12 months preceding the Screening Visit.
8. Acute hepatitis, chronic hepatitis, or detection of any unexplained elevation of serum ALT or AST greater than 1.5-fold ULN, at least twice in the 6 months before the Screening Visit) or HIV infection.
9. History of alcohol or drug abuse during the 12 months preceding the Screening Visit.
10. Vaccination with live vaccines during the 6 weeks preceding the Screening Visit.
11. Haemoglobin <9 g/dL or Haematocrit <30% at the Screening Visit
12. White blood cell (WBC) count <3.0 x 109/L at the Screening Visit.
13. Absolute neutrophil count <1.2 x 109/L at the Screening Visit.
14. Platelet count <100 x 109/L at the Screening Visit.
15. Serum alkaline-phosphatase, or gamma-glutamyl-transferase greater than 3-fold ULN; alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN At the Screening Visit.
16. Estimated creatinine clearance less than 45 mL/min/1.73 m2 (MDRD) at the Screening Visit.
17. 12-lead electrocardiogram (ECG) with abnormal clinically significant findings, as judged by the Investigator, at the Screening Visit.
18. Positive QuantiFERON-in-Tube test (QFG-IT).
19. Use of hydroxychloroquine during the 30 weeks preceding the Screening Visit.
20. Treatment with any systemic or intraarticular corticosteroid within 6 weeks before the Screening Visit.
21. Intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). Use of NSAIDs is allowed if used in a stable dose regimen for at least 4 weeks prior to the Screening Visit.
22. Use of other investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding the Screening Visit.
23. Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.