Trials / Completed
CompletedNCT03348046
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 22 (actual)
- Sponsor
- Hikma Pharmaceuticals LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Biosimilar Infliximab | A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg |
Timeline
- Start date
- 2017-03-23
- Primary completion
- 2019-04-14
- Completion
- 2019-04-14
- First posted
- 2017-11-20
- Last updated
- 2020-03-04
Locations
2 sites across 1 country: Jordan
Source: ClinicalTrials.gov record NCT03348046. Inclusion in this directory is not an endorsement.