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Completed

NCT Number: NCT04089514

A Real-world Study of Imraldi® Use

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.

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Key information

Conditions

Arthritis, Rheumatoid (RA) Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Psoriatic (PsA) Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Axial Spondyloarthritis (AxSpA) Bone Diseases Colitis Colitis, Ulcerative Colitis, Ulcerative (UC) Colonic Diseases Connective Tissue Diseases Crohn Disease Crohn's Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

Administered as specified in the treatment arm

Other names: Imraldi

Primary outcomes

  1. Candidate Predictors of Persistence on Adalimumab

    Time frame: Baseline up to Week 48

    Candidate predictors (baseline clinical characteristics, disease score as applicable, incidence and clinical management of flares, and patient satisfaction survey) will be assessed via cox regression which will result in a hazard ratio.

Secondary outcomes

  1. Number of Participants by Baseline Clinical Characteristic Categories

    Time frame: Baseline

    Baseline characteristics categories may include age, gender, diagnosis, duration of disease, relevant medical and surgical history, relevant co-morbidities, disease score, relevant concomitant therapies.

  2. Number of Participants by Utilization of Adalimumab Categories

    Time frame: Baseline up to Week 48

    Adalimumab utilization categories may include type, dose, dose frequency and mode of administration, any changes, reason(s) for change and/or discontinuation.

  3. Change from Baseline in Disease Scores as Applicable by Indication

    Time frame: Baseline up to Week 48

    Disease score as applicable by indication may include participant assessments of disease specific questionnaires (e.g. Disease Activity Score- 28 (DAS-28), Bath Ankylosing spondyloarthritis Functional Index (BASDAI), Harvey Bradshaw Index (HBI), Partial Mayo Score, Psoriatic Arthritis Response Criteria (PsARC))

  4. Patient Satisfaction with Biologic Administration

    Time frame: Baseline up to Week 48

    Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire.

  5. Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements

    Time frame: Baseline up to Week 48

    Clinical significance will be assessed by the investigator.

  6. Number of Participants by Utilization of Relevant Concomitant Medication Categories

    Time frame: Baseline up to Week 48

    Concomitant medication utilization categories may include type, dose, and any changes in use of relevant concomitant therapy.

  7. Number of Participants with Anti-drug Antibodies

    Time frame: Baseline up to Week 48

    Participants will be assessed for positive antibody results.

  8. Number of Participants with Serious Adverse Events (SAEs) and Causally-related Non-serious Adverse Events (AEs)

    Time frame: Baseline up to Week 48

    An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

Pan-EU Real-World Experience With Imraldi®

Acronym: PROPER

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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