None listed
Conditions
Interventions
Group 1 Type of group
R935788 50 mg tablet, orally, twice-a-day
Group name:Group 4 Type of group
R935788 150 mg tablet, orally, once-a-day
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Patients must provide written informed consent by signing an Informed Consent Form (FCI) approved by a CRI / CE before being admitted to this study. • Patients under treatment in Study C-788-006X • Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events • Patients who withdrew from Study C-788-010 at Month 4 or Month 5 due to a lack of predefined efficacy • Women of childbearing age should be fully informed about the potential of R788 to adversely affect the fetus and, if sexually active, should agree to use a well established contraceptive method during the study (oral contraceptives, mechanical barrier, long-acting hormonal agent) . These patients should not be breastfeeding and should have a negative pregnancy test at the time of inclusion and at each laboratory determination.
Exclusion criteria
Exclusion criteria: • The patient has a history of, or is currently suffering from, a clinically significant disease, medium condition (in addition to arthritis) or laboratory abnormality that, in the opinion of the Researcher, could affect the conduct of the study. Specifically, patients who suffer from the following are excluded: a) Grade 2 or greater toxicity in an RA protocol in which R788 was studied. b) poorly controlled or uncontrolled hypertension; c) recent serious surgery or infectious disease (in the last 2 months); d) recent history (since enrollment in the previous R788 study) of, or treatment for, a malignancy except non-melanomatous skin cancer, or any history of lymphoma; e) is known positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis; f) interstitial pneumonitis or active lung infection; g) known laboratory abnormalities: .ALT> 2xLNS, Creatinine> 1.5XLNS are excluded. ANC <2,500 / mm ^ 3 or 2.5X10 ^ 9 / L lymphocyte count <600 / mm3 or 0.6 x 10 ^ 9 / L, Hb <9 g / dL or 5mmol / L, platelet count <125,000 / mm ^ 3 or 125x10 ^ 9 / L. • The patient has a history of substance abuse, drug addiction or alcoholism. Patients can consume up to 4 units of alcohol a week; however, alcohol consumption should be avoided during the 72 hours prior to laboratory evaluations. Patients who cannot reliably meet this requirement should be excluded. One unit of alcohol is defined as: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet table wine = 3 oz or 89 mL; Spirits distilled with 80 ° alcohol = 1.5 oz or 44 mL. • The patient cannot go for clinical and laboratory monitoring according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Record of adverse events and serious adverse events at the time of their appearance. Measure:Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category Timepoints:Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patients global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily Measure:DAS28-CRP Score Timepoints:3 years ; Outcome name:Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day. Measure:HAQ-DI Score Timepoints:3 years | — |
Countries
Belgium, Bulgaria, France, Germany, Italy, Peru
Contacts
Public ContactGladys Aliaga
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed