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Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

NCT03452501 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2021-02-23

No results posted yet for this study

Summary

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the daily practice will be performed.

Conditions

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Fistulizing Crohn's Disease
  • Ulcerative Colitis

Interventions

DRUG

Infliximab

A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg

Sponsors & Collaborators

  • Hikma Pharmaceuticals LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-26
Primary Completion
2020-08-17
Completion
2020-08-17

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452501 on ClinicalTrials.gov