Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female aged ≥ 18 years
A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening
Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage
Patient must be willing to receive folic acid ≥5mg/wk 4 weeks prior to baseline administered according to locally accepted practice
Body mass index (BMI) \< 35kg/m2 (inclusive)
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
You may not be if
Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)
Glucocorticoid unless given in doses equivalent to ≤ 10 mg of prednisolone /day
Intra-articular, i.m. or IV corticosteroids
Live/attenuated vaccinations
Cyclosporine
Azathioprine
Penicillamine
Sulfasalazine
Bucillamine
Hydroxychloroquine
Chloroquine
Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment
Exposure to gold therapy ≤ 12 weeks prior to Visit 2
Exposure to IV immunogammaglobulins ≤ 24 weeks prior to Visit 2
Past or current malignant melanoma
Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
