Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
The duration of the study period per subject is 5-7 weeks broken down as follows:
* Screening: 1 to 14 days,
* Treatment: 1 day (2 overnight stays at the study site),
* Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of rheumatoid arthritis (RA) \> or = 3 months duration.
Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.
You may not be if
Autoimmune disease other than RA.
History of acute inflammatory joint disease other than RA.
Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
Latent or active tuberculosis.
Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).
Received tuberculosis vaccination within 12 months prior to screening
Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.
Known latex sensitivity.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
