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

Hikma

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Biosimilar Infliximab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03348046

RMS-JOR-2015-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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