Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
NCT ID: NCT03348046
Last Updated: 2020-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
22 participants
OBSERVATIONAL
2017-03-23
2019-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Biosimilar Infliximab
A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Previous treatment with biologics
* Patients who meet any of the contraindications to the administration of infliximab
* Previous or concurrent malignancies
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Hikma Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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Prince Hamza Hospital
Amman, , Jordan
Jordan University of Science and Technology- King Abdallah University Hospital
Irbid, , Jordan
Countries
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Other Identifiers
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RMS-JOR-2015-01
Identifier Type: -
Identifier Source: org_study_id
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