A Real-world Study of Imraldi® Use

Sponsor
Biogen
Study ID
NCT04089514
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Administered as specified in the treatment arm

Study Details

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.

Key Dates

Start date
Jun 30, 2019
Status verified
Apr 2023
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021

Study Design

Enrollment
1,000 participants (actual)

Arms

  • Arm: Adalimumab Therapy
    Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy

Primary Outcome Measure

Candidate Predictors of Persistence on Adalimumab [ Time Frame: Baseline up to Week 48 ]

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