Arthritis, Rheumatoid (RA)PROPERNCT04089514
A Real-world Study of Imraldi® Use
An observational study of Arthritis, Rheumatoid (RA) and Axial Spondyloarthritis (axSpA), run by Biogen at 54 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA)
- What is being tested?
- Adalimumab
- How many people
- 1,000 participants
- Where
- 54 sitesin 6 countries
- Study dates
- 30 Jun 2019to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator
Trial locations and contacts
54 sites in 6 countries.
54 sites in 6 countries
Germany16 sites
Research Site
Berlin
Research Site
Bruchhausen-Vilsen
Research Site
Burghausen
Research Site
Dresden
Research Site
Elmshorn
Research Site
Erfurt
Research Site
Halle
Research Site
Hamburg
Research Site
Hamm
Research Site
Heidelberg
Research Site
Magdeburg
Research Site
München
Research Site
Munich
Research Site
Münster
Research Site
Oldenburg
Research Site
Ratingen
Italy10 sites
Research Site
Ancona
Research Site
Bari
Research Site
Florence
Research Site
Foggia
Research Site
Milan
Research Site
Modena
Research Site
Pavia
Research Site
San Giovanni Rotondo
Research Site
Siena
Research Site
Varese
Belgium9 sites
Research Site
Bruges
Research Site
Brussels
Research Site
Genk
Research Site
Ghent
Research Site
Herentals
Research Site
Kortrijk
Research Site
Liège
Research Site
Sijsele
Research Site
Turnhout
Spain9 sites
Research Site
Almería
Research Site
Badajoz
Research Site
Donostia / San Sebastian
Research Site
Granada
Research Site
Mérida
Research Site
Sant Joan Despí
Research Site
Seville
Research Site
Terrassa
Research Site
Valladolid
United Kingdom9 sites
Research Site
Ashford
Research Site
Bath
Research Site
Belfast
Research Site
Cambridge
Research Site
Kettering
Research Site
Luton
Research Site
Norwich
Research Site
Nottingham
Research Site
Sussex
About this study
Official title: 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.
- Conditions
- Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA), Crohn's Disease (CD), Colitis, Ulcerative (UC)
- Being tested
- Adalimumab
- Keywords
- Biologics, Non-interventional, Real-world, Adalimumab, Europe
- Medical subject headings
- Arthritis, Rheumatoid, Axial Spondyloarthritis, Arthritis, Psoriatic, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Imraldi
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab Therapy | Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candidate Predictors of Persistence on Adalimumab
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.
Measured: Baseline up to Week 48
Secondary outcomes (8)
Number of Participants by Baseline Clinical Characteristic Categories
Baseline characteristics categories may include age, gender, diagnosis, duration of disease, relevant medical and surgical history, relevant co-morbidities, disease score, relevant concomitant therapies.
Measured: Baseline
Number of Participants by Utilization of Adalimumab Categories
Adalimumab utilization categories may include type, dose, dose frequency and mode of administration, any changes, reason(s) for change and/or discontinuation.
Measured: Baseline up to Week 48
Change from Baseline in Disease Scores as Applicable by Indication
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))
Measured: Baseline up to Week 48
Patient Satisfaction with Biologic Administration
Patient satisfaction with biologic administration will be assessed via a patient satisfaction questionnaire.
Measured: Baseline up to Week 48
Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements
Clinical significance will be assessed by the investigator.
Measured: Baseline up to Week 48
Number of Participants by Utilization of Relevant Concomitant Medication Categories
Concomitant medication utilization categories may include type, dose, and any changes in use of relevant concomitant therapy.
Measured: Baseline up to Week 48
Number of Participants with Anti-drug Antibodies
Participants will be assessed for positive antibody results.
Measured: Baseline up to Week 48
Number of Participants with Serious Adverse Events (SAEs) and Causally-related Non-serious Adverse Events (AEs)
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.
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start30 Jun 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, Rheumatoid (RA)Studies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089514
- Sponsor's protocol ID
- EUR-BIO-18-11391
- Acronym
- PROPER
- Status last verified
- Apr 2023
- First submitted
- 12 Sep 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Publications
Muller-Ladner U, Dignass A, Gaffney K, Jadon D, Matucci-Cerinic M, Lobaton T, Carron P, Gisbert JP, Pande I, Utzinger M, Addison J. The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune-Mediated Inflammatory Disease. BioDrugs. 2023 Nov;37(6):873-889. doi: 10.1007/s40259-023-00616-3. Epub 2023 Aug 26.
PubMed 37632666
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-EU Real-World Experience With Imraldi®
- ClinicalTrials.gov ID
- NCT04089514
- Acronym / sponsor ID
- PROPER / EUR-BIO-18-11391
- Conditions
- Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA), Crohn's Disease (CD), Colitis, Ulcerative (UC)
- Keywords
- Biologics, Non-interventional, Real-world, Adalimumab, Europe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab Therapy | – | Drug: AdalimumabAdult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: ImraldiAdministered as specified in the treatment arm | Drug | Adalimumab Therapy |
Primary outcome
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.
8 secondary outcomes
Number of Participants by Baseline Clinical Characteristic Categories
Time frame: Baseline
Number of Participants by Utilization of Adalimumab Categories
Time frame: Baseline up to Week 48
Change from Baseline in Disease Scores as Applicable by Indication
Time frame: Baseline up to Week 48
Patient Satisfaction with Biologic Administration
Time frame: Baseline up to Week 48
Number of Participants with Clinically Significant Laboratory Values and Clinical Evaluation Measurements
Time frame: Baseline up to Week 48
Number of Participants by Utilization of Relevant Concomitant Medication Categories
Time frame: Baseline up to Week 48
Number of Participants with Anti-drug Antibodies
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 37632666Muller-Ladner U, Dignass A, Gaffney K, Jadon D, Matucci-Cerinic M, Lobaton T, Carron P, Gisbert JP, Pande I, Utzinger M, Addison J. The PROPER Study: A 48-Week, Pan-European, Real-World Study of Biosimilar SB5 Following Transition from Reference Adalimumab in Patients with Immune-Mediated Inflammatory Disease. BioDrugs. 2023 Nov;37(6):873-889. doi: 10.1007/s40259-023-00616-3. Epub 2023 Aug 26.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
54 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid (RA) and Axial Spondyloarthritis (axSpA), run by Biogen at 54 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, Italy, Belgium, Spain, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candidate Predictors of Persistence on Adalimumab (time frame: Baseline up to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04089514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.