Rheumatoid ArthritisIDEANCT05190484
bIosimilar of aDalimumab, an European evAluation
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Fresenius Kabi.
Trial summary
The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- How many people
- 1,050 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include male and female adult patients with an IMID who were prescribed FK adalimumab, meet all the study inclusion criteria and none of the exclusion criteria and provide written informed consent to participate.
Who may be able to join
- Age ≥18 years, male or female.
- Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
- Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
- Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
- Patients able to understand and complete the study questionnaires in local language during the study visits.
- Patients willing to sign informed consent to meet data protection requirements
Who cannot join
- Unwillingness to provide written informed consent.
- Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
- Patients not expected to be available for study visits during 12 months.
About this study
Official title: An International, Prospective, Observational Study of Patients With Chronic Inflammatory Diseases, to Assess 12-months Persistence Drivers After Switching to an Adalimumab Biosimilar, Idacio®, in a Real World Setting
The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis
- Keywords
- adalimumab, biosimilar
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
TREATMENT DISCONTINUATION
A patient will be considered to have discontinued FK adalimumab (not persistent) if the investigator reports a permanent discontinuation or if the patient has been more than 90 consecutive days not covered by treatment (based on the refills reported).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start30 Apr 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190484
- Sponsor's protocol ID
- ADAL-004-CNI
- Acronym
- IDEA
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Prospective, Observational Study of Patients With Chronic Inflammatory Diseases, to Assess 12-months Persistence Drivers After Switching to an Adalimumab Biosimilar, Idacio®, in a Real World Setting
- ClinicalTrials.gov ID
- NCT05190484
- Acronym / sponsor ID
- IDEA / ADAL-004-CNI
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis
- Keywords
- adalimumab, biosimilar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to FK adalimumab, in order to develop a model to predict persistence at 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include male and female adult patients with an IMID who were prescribed FK adalimumab, meet all the study inclusion criteria and none of the exclusion criteria and provide written informed consent to participate.
Key inclusion criteria (6 listed)
- Age ≥18 years, male or female.
- Patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases.
- Patients who have been switched to FK adalimumab from the reference product (Humira®) or another adalimumab biosimilar.
- Patients who have been prescribed FK adalimumab according to the SmPC prior to the inclusion.
- Patients able to understand and complete the study questionnaires in local language during the study visits.
Key exclusion criteria (3 listed)
- Unwillingness to provide written informed consent.
- Patients participating or expected to participate in any randomised clinical trial during their treatment with FK adalimumab.
- Patients not expected to be available for study visits during 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TREATMENT DISCONTINUATION
Time frame: 12 months
A patient will be considered to have discontinued FK adalimumab (not persistent) if the investigator reports a permanent discontinuation or if the patient has been more than 90 consecutive days not covered by treatment (based on the refills reported).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Fresenius Kabi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TREATMENT DISCONTINUATION (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.