Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Advanced Accelerator Applications
The study was terminated early after the inclusion of 16 of the 20 planned patients. The sponsor decided to terminate the study earlier than planned due to slow accrual. Novartis acquired Advanced Accelerator Applications SA.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients diagnosed with RA based on ACR/EULAR 2010 criteria (score \>=6), or Patients diagnosed with AS based on the ASAS criteria. Patients with RA must have serology assessment performed and documented at the time of enrollment.
Patient with RA active disease (DAS \> 2,6) and the introduction of a Bi-DMARD should be indicated. RA patients must have been treated with DMARD (methotrexate, leflunomide and sulfasalazine) or combination of these treatments for at least 3 months. Treatment will be pursued while on study.
or RA patients must have been previously treated with Bi-DMARD before initiation of the new Bi-DMARD treatment. The non-response of the previous Bi-DMARD treatment must be documented.
or Patients with AS with insufficiently controlled disease while under NSAID and indication for Bi-DMARD. These patients must be under NSAID for at least 3 months and under the same NSAID for at least 1 month prior to enrollment.
≥ 18 years old
Karnofsky ≥ 80%
Negative Pregnancy test for women with childbearing potential
For women with childbearing potential, use of two reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, associated with other barrier method of contraception such as the use of condoms) , throughout their participation in the study
Absence of ECG anomaly
written ICF signed
You may not be if
Pregnancy or lactation
Liver impairment (ALT, AST or Bilirubin \> 2 ULN) at screening visit or baseline
Kidney impairment (serum creatinine \> 1.5 mg/dL)
History of congestive heart failure (NYHA III \& IV)
History of malignant disease within 5 years
History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
Known hypersensitivity to the investigational drug or any of its components
Participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
