A Real-world Study of Imraldi® Use (PROPER)
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|ClinicalTrials.gov Identifier: NCT04089514|
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment|
|Arthritis, Rheumatoid (RA) Axial Spondyloarthritis (axSpA) Arthritis, Psoriatic (PsA) Crohn's Disease (CD) Colitis, Ulcerative (UC)||Drug: Adalimumab|
|Study Type :||Observational|
|Estimated Enrollment :||1400 participants|
|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|
Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy
Administered as specified in the treatment arm
Other Name: Imraldi
- 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.
- 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.
- 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.
- 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))
- 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.
- 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.
- 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.
- Number of Participants with Anti-drug Antibodies [ Time Frame: Baseline up to Week 48 ]Participants will be assessed for positive antibody results.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04089514
|Contact: US Biogen Clinical Trial Centerfirstname.lastname@example.org|
|Contact: Global Biogen Clinical Trial Centeremail@example.com|
|Bath, United Kingdom|
|Study Director:||Medical Director||Biogen|