A Real-world Study of Imraldi® Use

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04089514
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Biogen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Biogen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid (RA), Axial Spondyloarthritis (axSpA), Arthritis, Psoriatic (PsA), Crohn's Disease (CD), Colitis, Ulcerative (UC)
Arms & Interventions

Arms

: Adalimumab Therapy

Adult participants diagnosed with immune-mediated inflammatory disease will receive adalimumab as a prescribed therapy

Interventions

Drug: - Adalimumab

Administered as specified in the treatment arm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Research Site, Berlin, Germany

Status

Recruiting

Address

Research Site

Berlin, ,

Research Site, Bruchhausen-Vilsen, Germany

Status

Recruiting

Address

Research Site

Bruchhausen-Vilsen, ,

Research Site, Dresden, Germany

Status

Recruiting

Address

Research Site

Dresden, ,

Research Site, Elmshorn, Germany

Status

Recruiting

Address

Research Site

Elmshorn, ,

Research Site, Erfurt, Germany

Status

Recruiting

Address

Research Site

Erfurt, ,

Research Site, Magdeburg, Germany

Status

Recruiting

Address

Research Site

Magdeburg, ,

Research Site, Munchen, Germany

Status

Recruiting

Address

Research Site

Munchen, ,

Research Site, Ratingen, Germany

Status

Recruiting

Address

Research Site

Ratingen, ,

Research Site, Bath, United Kingdom

Status

Recruiting

Address

Research Site

Bath, ,

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