Status:
COMPLETED
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Lead Sponsor:
Hikma Pharmaceuticals LLC
Collaborating Sponsors:
Syneos Health
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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) additi...
Detailed 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 pati...
Eligibility Criteria
Inclusion
- 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
- Patient \<18 years
- Previous treatment with biologics
- Patients who meet any of the contraindications to the administration of infliximab
- Previous or concurrent malignancies
Key Trial Info
Start Date :
March 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 14 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03348046
Start Date
March 23 2017
End Date
April 14 2019
Last Update
March 4 2020
Active Locations (2)
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1
Prince Hamza Hospital
Amman, Jordan
2
Jordan University of Science and Technology- King Abdallah University Hospital
Irbid, Jordan