Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of active rheumatoid arthritis in the previous 6 months (according to the ACR guidelines)
Must have active disease to be initiated by DMARDs (Disease Modifying Anti-Rheumatic Drugs)
You may not be if
Patient presenting or having a history of other inflammatory joint disease
Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme
Patient with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis
Persistent infection or severe infection within 3 months before enrollment,
Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study,
Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
Severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin \< 3.0 g/dl
Moderate or severe impairment of renal function, as known by serum creatinine \> 133 mcmol/L (or 1.5 mg/dl)
Patient with history of recent and clinically significant drug or alcohol abuse
Impairment of liver function or persisting ALT (SGPT) elevations of more than 2-fold the upper limit of normal
Pregnancy
Breastfeeding
Women of childbearing potential, except if they fulfill specific conditions,
Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 month with the washout procedure)
Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation
Known HIV positive status
Known positive serology for hepatitis B or C
Patient with hypersensitivity to any of the excipients in the tablets of leflunomide
Previous therapy at any time with:
* any DMARD including methotrexate, oral or injectable gold salts, chloroquine, hydroxychloroquine, ciclosporin, azathioprine, methotrexate, sulfasalazine
