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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
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date September 12, 2019
First Posted Date September 13, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date June 30, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2019)		 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04089514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 12, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Real-world Study of Imraldi® Use
Official Title Pan-EU Real-World Experience With Imraldi®
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)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Arthritis, Rheumatoid (RA)
  • Axial Spondyloarthritis (axSpA)
  • Arthritis, Psoriatic (PsA)
  • Crohn's Disease (CD)
  • Colitis, Ulcerative (UC)
Intervention Drug: Adalimumab
Administered as specified in the treatment arm
Other Name: Imraldi
Study Groups/Cohorts Adalimumab Therapy
Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy
Intervention: Drug: Adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 12, 2019)		 1400
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04089514
Other Study ID Numbers EUR-BIO-18-11391
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: http://www.biogenclinicaldatarequest.com/
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date October 2019