Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - Adult (aged 18 or older at the time of inclusion) rheumatology or gastroenterology patients presenting a diagnosis for any of the following pathologies : Rheumatoid Arthritis (RA) Ankylosing Spondylarthritis (AS) Axial Spondyloarthritis with no signs of AS (AxSpa) Psoriatic Arthritis (PsA) Crohn's Disease (CD) Ulcerative Colitis (UC) - Stable and treated for at least 3 months prior to inclusion either with an adalimumab (ADA) biosimilar or originator adalimumab (40 mg dose injections only) - For whom the treating physician has decided to switch to Yuflyma® (40 mg / 0.4 mL) on the day of their inclusion (decision independent from the study) - Able to initiate treatment within 4 weeks of inclusion.
- - Have an email account.
- - Have a mobile phone number.
- - Able to understand and complete French-language questionnaires.
- - Are not opposed to participating in the study.
- - Are covered by French National Health Insurance.
inclusion Criteria:Patients meeting any of the following exclusion criteria will not be included in the study:
- - Patients younger than 18 years old at the date of inclusion.
- - Patients treated with adalimumab for any other pathology than those specified in the inclusion criteria.
- - Patients treated with adalimumab originator 80 mg.
- - Patients under curatorship or guardianship or otherwise deprived of liberty.
- - Patients unable to understand and complete French-language questionnaires.
- - Pregnant women or women of childbearing potential with a desire of becoming pregnant concomitant to treatment with Yuflyma®.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Celltrion HealthCare France|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Rheumatoid Arthritis, Ankylosing Spondylarthritis, Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis|
|Study Website:||View Trial Website|
: Switch from adalimumab originator
: Switch from adalimumab biosimilar 40 mg/0,8 mL
Drug: - Adalimumab
Stable and treated for at least 3 months prior to inclusion either with an adalimumab biosimilar or originator adalimumab (40 mg dose injections only) and for whom the treating physician has decided to switch to Yuflyma® (40 mg / 0.4 mL) on the day of their inclusion (decision independent from the study)
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.