Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
The purpose of this observational study is to assess the safety and effectiveness of
 biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or
 intervention(s) additional to the daily practice will be performed
A multi-center, observational, prospective, cohort study to assess the safety and
 effectiveness of biosimilar Infliximab (Remsima®) in patients with rheumatoid arthritis in
 Jordan. Biologic naïve patients will receive Remsima® in accordance with standard medical
 care and the approved label and will be followed over a period of 34 weeks (8.5 months).
 Outcomes including occurrence of adverse events (AEs), mean changes in disease activity and
 health assessment in each cohort will be measured and compared
Inclusion Criteria:

 -  Adult patients (age ≥18 years)

 -  Biologic naïve patients with active RA diagnosed according to the revised 1987
 American College of Rheumatology (ACR) (Arnett et al. 1988) or 2010 ACR / European
 League Against Rheumatism (EULAR) Rheumatoid Arthritis classification criteria
 (Aletaha et al. 2010)

 -  Patients should be receiving a stable dose Methotrexate (MTX) for at least 3 months
 prior to enrolment, and still have active disease defined as erythrocyte sedimentation
 rate (ESR) ≥28 mm/h and swollen and tender joints ≥ 6

 -  Absence of tuberculosis demonstrated by negative chest X-ray

 Exclusion Criteria:

 -  Patient <18 years

 -  Previous treatment with biologics

 -  Patients who meet any of the contraindications to the administration of infliximab

 -  Previous or concurrent malignancies