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

April 14, 2023 updated by: Biogen

Pan-EU Real-World Experience With Imraldi®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • Research Site
      • Bruxelles, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Herentals, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Liège, Belgium
        • Research Site
      • Sijsele, Belgium
        • Research Site
      • Turnhout, Belgium
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Bruchhausen-Vilsen, Germany
        • Research Site
      • Burghausen, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Elmshorn, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hamm, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Munich, Germany
        • Research Site
      • Münster, Germany
        • Research Site
      • Oldenburg, Germany
        • Research Site
      • Ratingen, Germany
        • Research Site
  • Ireland
      • Dublin, Ireland
        • Research Site
  • Italy
      • Ancona, Italy
        • Research Site
      • Bari, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Foggia, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Modena, Italy
        • Research Site
      • Pavia, Italy
        • Research Site
      • San Giovanni Rotondo, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Varese, Italy
        • Research Site
  • Spain
      • Almeria, Spain
        • Research Site
      • Badajoz, Spain
        • Research Site
      • Donostia, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Mérida, Spain
        • Research Site
      • Sant Joan Despi, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Terrassa, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
  • United Kingdom
      • Ashford, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • Kettering, United Kingdom
        • Research Site
      • Luton, United Kingdom
        • Research Site
      • Norwich, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Sussex, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with RA, or axSpA, or PsA, or CD, or UC, who are receiving biosimilar adalimumab (Imraldi®) therapy for their immune-mediated inflammatory disease.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adalimumab Therapy
Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy
Drug: Adalimumab
Administered as specified in the treatment arm
Other Names:
  • Imraldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline up to Week 48
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))
Baseline up to Week 48
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.
Baseline up to Week 48
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.
Baseline up to Week 48
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.
Baseline up to Week 48
Number of Participants with Anti-drug Antibodies
Time Frame: Baseline up to Week 48
Participants will be assessed for positive antibody results.
Baseline up to Week 48
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.
Baseline up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

September 12, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUR-BIO-18-11391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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