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A Real-world Study of Imraldi® Use

NCT04089514 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-04-18

No results posted yet for this study

Summary

The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU).

The secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of Imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events.

Conditions

  • Arthritis, Rheumatoid (RA)
  • Axial Spondyloarthritis (axSpA)
  • Arthritis, Psoriatic (PsA)
  • Crohn's Disease (CD)
  • Colitis, Ulcerative (UC)

Interventions

DRUG

Adalimumab

Administered as specified in the treatment arm

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Drug
Yes

Countries

  • Belgium
  • Germany
  • Ireland
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04089514 on ClinicalTrials.gov