Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

pregnancy or breast feeding. ongoing or completed mechanical ventilation. in the opinion of the investigator, unlikely to survive for >48 hours from screening. in the opinion of the investigator, expected overall survival due to other comorbidities less than 3 months. severe renal dysfunction egfr < 30 ml/min. medical history including chronic liver disease with inflammation, fibrosis or cirrhosis including underlying diseases such as alcoholic liver disease, non-alcoholic fatty liver disease, chronic viral hepatitis, alcoholic liver disease, autoimmune liver disease, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, or carcinoma. uncontrolled hypertension systolic bp >180 mm hg, diastolic bp > 110 mm hg. history of hypersensitivity to the study drugs presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2 x 109/l, aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 x upper limit of normal (uln), platelets <100 x 109/l treatment with anakinra, anti-il 6, anti-il-6r antagonists, janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day. ongoing acute treatment for covid-19 with any peroral or iv steroid is permitted for up to five days before inclusion. chronic or acute treatment with inhaled steroids is also permitted history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis acute systemic infection; verified by blood cultures systemic bacterial infection, systemic fungi-infection or prosthesis-related infection history of stem-cell or solid organ transplantation known active tuberculosis (tb), history of incompletely treated tb, suspected or known extrapulmonary tb, suspected or known systemic bacterial or fungal infections diagnosis of, or suspicion of hiv infection, acute hepatitis a and/or chronic hepatitis b and/or c previous history of gastrointestinal ulceration or diverticulitis. patients who have received immunosuppressive antibody therapy within the past 3 months, including intravenous immunoglobulin or plans to receive during the study period participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. the use of remdesivir is permitted. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

pregnancy or breast feeding. ongoing or completed mechanical ventilation. in the opinion of the investigator, unlikely to survive for >48 hours from screening. in the opinion of the investigator, expected overall survival due to other comorbidities less than 3 months. severe renal dysfunction egfr < 30 ml/min. medical history including chronic liver disease with inflammation, fibrosis or cirrhosis including underlying diseases such as alcoholic liver disease, non-alcoholic fatty liver disease, chronic viral hepatitis, alcoholic liver disease, autoimmune liver disease, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, or carcinoma. uncontrolled hypertension systolic bp >180 mm hg, diastolic bp > 110 mm hg. history of hypersensitivity to the study drugs presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2 x 109/l, aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 x upper limit of normal (uln), platelets <100 x 109/l treatment with anakinra, anti-il 6, anti-il-6r antagonists, janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day. ongoing acute treatment for covid-19 with any peroral or iv steroid is permitted for up to five days before inclusion. chronic or acute treatment with inhaled steroids is also permitted history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis acute systemic infection; verified by blood cultures systemic bacterial infection, systemic fungi-infection or prosthesis-related infection history of stem-cell or solid organ transplantation known active tuberculosis (tb), history of incompletely treated tb, suspected or known extrapulmonary tb, suspected or known systemic bacterial or fungal infections diagnosis of, or suspicion of hiv infection, acute hepatitis a and/or chronic hepatitis b and/or c previous history of gastrointestinal ulceration or diverticulitis. patients who have received immunosuppressive antibody therapy within the past 3 months, including intravenous immunoglobulin or plans to receive during the study period participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. the use of remdesivir is permitted. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

Feb. 20, 2021, 12:31 a.m. usa

1. pregnancy or breast feeding. 2. ongoing or completed mechanical ventilation. 3. in the opinion of the investigator, unlikely to survive for >48 hours from screening. 4. in the opinion of the investigator, expected overall survival due to other comorbidities less than 3 months. 5. severe renal dysfunction egfr < 30 ml/min. 6. medical history including chronic liver disease with inflammation, fibrosis or cirrhosis including underlying diseases such as alcoholic liver disease, non-alcoholic fatty liver disease, chronic viral hepatitis, alcoholic liver disease, autoimmune liver disease, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, or carcinoma. 7. uncontrolled hypertension systolic bp >180 mm hg, diastolic bp > 110 mm hg. 8. history of hypersensitivity to the study drugs 9. presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2 x 109/l, aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 x upper limit of normal (uln), platelets <100 x 109/l 10. treatment with anakinra, anti-il 6, anti-il-6r antagonists, janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period 11. current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents 12. use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day. ongoing acute treatment for covid-19 with any peroral or iv steroid is permitted for up to five days before inclusion. chronic or acute treatment with inhaled steroids is also permitted 13. history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis 14. acute systemic infection; verified by blood cultures systemic bacterial infection, systemic fungi-infection or prosthesis-related infection 15. history of stem-cell or solid organ transplantation 16. known active tuberculosis (tb), history of incompletely treated tb, suspected or known extrapulmonary tb, suspected or known systemic bacterial or fungal infections 17. diagnosis of, or suspicion of hiv infection, acute hepatitis a and/or chronic hepatitis b and/or c 18. previous history of gastrointestinal ulceration or diverticulitis. 19. patients who have received immunosuppressive antibody therapy within the past 3 months, including intravenous immunoglobulin or plans to receive during the study period 20. participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. the use of remdesivir is permitted. 21. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

1. pregnancy or breast feeding. 2. ongoing or completed mechanical ventilation. 3. in the opinion of the investigator, unlikely to survive for >48 hours from screening. 4. in the opinion of the investigator, expected overall survival due to other comorbidities less than 3 months. 5. severe renal dysfunction egfr < 30 ml/min. 6. medical history including chronic liver disease with inflammation, fibrosis or cirrhosis including underlying diseases such as alcoholic liver disease, non-alcoholic fatty liver disease, chronic viral hepatitis, alcoholic liver disease, autoimmune liver disease, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, or carcinoma. 7. uncontrolled hypertension systolic bp >180 mm hg, diastolic bp > 110 mm hg. 8. history of hypersensitivity to the study drugs 9. presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2 x 109/l, aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 x upper limit of normal (uln), platelets <100 x 109/l 10. treatment with anakinra, anti-il 6, anti-il-6r antagonists, janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period 11. current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents 12. use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day. ongoing acute treatment for covid-19 with any peroral or iv steroid is permitted for up to five days before inclusion. chronic or acute treatment with inhaled steroids is also permitted 13. history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis 14. acute systemic infection; verified by blood cultures systemic bacterial infection, systemic fungi-infection or prosthesis-related infection 15. history of stem-cell or solid organ transplantation 16. known active tuberculosis (tb), history of incompletely treated tb, suspected or known extrapulmonary tb, suspected or known systemic bacterial or fungal infections 17. diagnosis of, or suspicion of hiv infection, acute hepatitis a and/or chronic hepatitis b and/or c 18. previous history of gastrointestinal ulceration or diverticulitis. 19. patients who have received immunosuppressive antibody therapy within the past 3 months, including intravenous immunoglobulin or plans to receive during the study period 20. participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. the use of remdesivir is permitted. 21. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

Oct. 26, 2020, 11:31 p.m. usa

1. pregnancy or breast feeding. 2. ongoing or completed mechanical ventilation. 3. in the opinion of the investigator, unlikely to survive for >48 hours from screening. 4. in the opinion of the investigator, expected overall survival due to other comorbidities less than 3 months. 5. chronic impairment of cardiac function nyha ii or higher. 6. severe renal dysfunction egfr < 30 ml/min. 7. medical history including chronic liver disease with inflammation, fibrosis or cirrhosis including underlying diseases such as alcoholic liver disease, non-alcoholic fatty liver disease, chronic viral hepatitis, alcoholic liver disease, autoimmune liver disease, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, or carcinoma. 8. uncontrolled hypertension systolic bp >180 mm hg, diastolic bp > 110 mm hg 9. history of hypersensitivity to the study drugs 10. presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2 x 109/l, aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 x upper limit of normal (uln), platelets <100 x 109/l 11. treatment with anakinra, anti-il 6, anti-il-6r antagonists, janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period 12. current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents 13. use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day 14. history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis 15. acute systemic infection; verified by blood cultures systemic bacterial infection, systemic fungi-infection or prosthesis-related infection 16. history of stem-cell or solid organ transplantation 17. known active tuberculosis (tb), history of incompletely treated tb, suspected or known extrapulmonary tb, suspected or known systemic bacterial or fungal infections 18. diagnosis of, or suspicion of hiv infection, acute hepatitis a and/or chronic hepatitis b and/or c 19. previous history of gastrointestinal ulceration or diverticulitis. 20. patients who have received immunosuppressive antibody therapy within the past 3 months, including intravenous immunoglobulin or plans to receive during the study period 21. participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. the use of remdesivir in the context of a single-arm remdesivir compassionate use protocol is permitted) 22. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study

1. pregnancy or breast feeding. 2. ongoing or completed mechanical ventilation. 3. in the opinion of the investigator, unlikely to survive for >48 hours from screening. 4. in the opinion of the investigator, expected overall survival due to other comorbidities less than 3 months. 5. chronic impairment of cardiac function nyha ii or higher. 6. severe renal dysfunction egfr < 30 ml/min. 7. medical history including chronic liver disease with inflammation, fibrosis or cirrhosis including underlying diseases such as alcoholic liver disease, non-alcoholic fatty liver disease, chronic viral hepatitis, alcoholic liver disease, autoimmune liver disease, hemochromatosis, wilson's disease, alpha-1 antitrypsin deficiency, cholangitis, or carcinoma. 8. uncontrolled hypertension systolic bp >180 mm hg, diastolic bp > 110 mm hg 9. history of hypersensitivity to the study drugs 10. presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (anc) less than 2 x 109/l, aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 5 x upper limit of normal (uln), platelets <100 x 109/l 11. treatment with anakinra, anti-il 6, anti-il-6r antagonists, janus kinase inhibitors (jaki) in the past 30 days or plans to receive during the study period 12. current treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents 13. use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisone 10 mg or equivalent per day 14. history of, or current autoimmune or inflammatory systemic or localized disease(s) other than rheumatoid arthritis 15. acute systemic infection; verified by blood cultures systemic bacterial infection, systemic fungi-infection or prosthesis-related infection 16. history of stem-cell or solid organ transplantation 17. known active tuberculosis (tb), history of incompletely treated tb, suspected or known extrapulmonary tb, suspected or known systemic bacterial or fungal infections 18. diagnosis of, or suspicion of hiv infection, acute hepatitis a and/or chronic hepatitis b and/or c 19. previous history of gastrointestinal ulceration or diverticulitis. 20. patients who have received immunosuppressive antibody therapy within the past 3 months, including intravenous immunoglobulin or plans to receive during the study period 21. participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. the use of remdesivir in the context of a single-arm remdesivir compassionate use protocol is permitted) 22. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study