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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03348046
Date of registration: 16/11/2017
Prospective Registration: Yes
Primary sponsor: Hikma Pharmaceuticals LLC
Public title: Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan PASSRRA
Scientific title: Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Date of first enrolment: March 23, 2017
Target sample size: 22
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03348046
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Jordan
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Biosimilar Infliximab
Primary Outcome(s)
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima® [Time Frame: 8.5 months]
Secondary Outcome(s)
Mean changes in Disability Index of the Health Assessment Questionnaire (HAQ-DI) [Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses]
Mean changes in disease activity scores (DAS28)- Global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS) [Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses]
Mean changes in disease activity scores (DAS28)- Number of swollen joints [Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses]
Mean changes in disease activity scores (DAS28)-ESR (Erythrocyte Sedimentation Rate) [Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses]
Mean changes in disease activity scores (DAS28)-Number of tender joints [Time Frame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses]
Secondary ID(s)
RMS-JOR-2015-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Syneos Health
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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