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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04089514
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : October 14, 2019
Information provided by (Responsible Party):

Brief 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)

Condition or disease Intervention/treatment
Arthritis, Rheumatoid (RA) Axial Spondyloarthritis (axSpA) Arthritis, Psoriatic (PsA) Crohn's Disease (CD) Colitis, Ulcerative (UC) Drug: Adalimumab

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Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pan-EU Real-World Experience With Imraldi®
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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 Name: Imraldi

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04089514

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Contact: US Biogen Clinical Trial Center 866-633-4636
Contact: Global Biogen Clinical Trial Center

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Research Site Recruiting
Berlin, Germany
Research Site Recruiting
Bruchhausen-Vilsen, Germany
Research Site Recruiting
Dresden, Germany
Research Site Recruiting
Elmshorn, Germany
Research Site Recruiting
Erfurt, Germany
Research Site Recruiting
Magdeburg, Germany
Research Site Recruiting
Munchen, Germany
Research Site Recruiting
Ratingen, Germany
United Kingdom
Research Site Recruiting
Bath, United Kingdom
Sponsors and Collaborators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen Identifier: NCT04089514    
Other Study ID Numbers: EUR-BIO-18-11391
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on

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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
Keywords provided by Biogen:
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Arthritis, Psoriatic
Crohn Disease
Colitis, Ulcerative
Joint Diseases
Musculoskeletal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Spinal Diseases
Bone Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents