Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study a) An ICF Addendum must be signed by any patient with a history of thrombo-embolic event(s) (e.g., deep vein thrombosis, pulmonary embolism, etc.) or abnormal activated protein C (APC) resistance test result (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator’s opinion, could affect the conduct of the study. Specifically, excluded are patients with the following: a)unresolved Grade 2 or greater toxicity in a RA protocol studying R788. b)uncontrolled or poorly controlled hypertension; c)recent (within past 2 months) serious surgery or infectious disease; d)recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma; e)known to be positive for Hepatitis B, Hepatitis C or Tuberculosis; f)interstitial pneumonitis or active pulmonary infection; g)known laboratory abnormalities: ALT > 1.2x ULN, Alk Phos > 2x ULN, creatinine > 1.5x ULN, an ANC < 1,500/mm3 or 1.5 x 109/L, Hgb < 9 g/dL or 5 mmol/L, platelet count < 125,000/mm3 or 125 x 109/L are excluded. 2)The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL. 3)The patient is unable to report for clinical and laboratory monitoring as per protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the long term safety of R788 in patients with Rheumatoid Arthritis (RA) who completed the treatment phase of Study C 935788 006X (C 788 006X), C 935788 010 (C 788 010), or C 935788-011 (C 788 011).;Secondary Objective: The secondary objective of this study is to investigate the long term efficacy of R788 in patients with RA who completed the treatment phase of Study C 788 006X, C 788 010, or C 788 011.;Primary end point(s): This is an open-label study with no end point. | — |
Countries
Belgium, Bulgaria, France, Germany, Italy
Outcome results
None listed