A Real-world Study of Imraldi® Use (PROPER)

Biogen

Status: Completed

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

Treatments: Drug: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04089514

EUR-BIO-18-11391

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Initiation on Imraldi® therapy after 18th October 2018, as part of routine treatment immediately after transitioning from at least 16 weeks' treatment with originator adalimumab (Humira®)
• Availability of at least one Baseline disease score (i.e. within 16 weeks prior or up to 6 weeks post-initiation of Imraldi®)
• Should provide informed consent to participate in the study

Exclusion criteria

• Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator

Trial design

1,000 participants in 1 patient group

Adalimumab Therapy

Description:

Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy

Treatment:

Drug: Adalimumab