Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Launched by HIKMA PHARMACEUTICALS LLC · Nov 17, 2017

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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