Clinical trial · Observational
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
NCT03348046CI-TRIAL-00043787PASSRRAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biosimilar Infliximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to Remsima®
- timeFrame
- 8.5 months
- description
- Rate of AEs leading to permanent treatment discontinuation and rate of clinically relevant changes in laboratory tests will be calculated
Secondary outcomes (5)
- 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
- description
- The Disease Activity Score (DAS) measures the disease activity in patients with Rheumatoid Arthritis (RA). DAS28 is a validated simplified tool in which twenty-eight joints are measured. The number of swollen joints will be assessed.
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.