Clinical trial NCT03348046: Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Official title: Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Infliximab
Remsima
Biosimilar
Autoimmune Disease
Rheumatoid Arthritis
Cohort Study
Disease modifying anti-rheumatic drugs
Tumor necrosis factor-alpha inhibitors
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2017-11-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from rheumatology outpatient clinics of 2 hospitals in Jordan

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) additional to the daily practice will be performed

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 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

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

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima®
timeFrame: 8.5 months
Secondary outcomes:
measure: Mean changes in disease activity scores (DAS28)- Number of swollen joints
timeFrame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
measure: Mean changes in disease activity scores (DAS28)-Number of tender joints
timeFrame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
measure: Mean changes in disease activity scores (DAS28)-ESR (Erythrocyte Sedimentation Rate)
timeFrame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
measure: Mean changes in disease activity scores (DAS28)- Global assessment of disease activity on a 100 mm Visual Analogue Scale (VAS)
timeFrame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
measure: Mean changes in Disability Index of the Health Assessment Questionnaire (HAQ-DI)
timeFrame: 8.5 months, changes between baseline and last visit will be compared between visits using repeated measure analyses
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Prince Hamza Hospital
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology- King Abdallah University Hospital
Study officials:
References: