Arthritis, RheumatoidArthritisNCT05062421
Persistence of Biological Treatment and Inhibitors of Jak Kinases in Patients With Rheumatoid Arthritis.
An observational study of Arthritis, Rheumatoid, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 540 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients aged > 18 years diagnosed with rheumatoid arthritis, who have been under treatment with at least one dose of the study drugs, whose treatment is followed by the rheumatology unit.
Who may be able to join
- Patients aged ≥18 years.
- With a diagnosis of Adult Rheumatoid Arthritis according to the 2010 ACR / EULAR criteria.
- Who have received at least one of the doses of the study drugs.
- In follow-up in the consultations of the UGC of Rheumatology of the HUVM.
- With at least two complete evaluations (baseline and final) of clinical variables.
Who cannot join
- Patients where the medical records lack sufficient baseline and final variables to perform the analysis.
- Patients in whom more than 50% of the variables to be collected are missing in the data collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen macarena
Seville, 41009
Blanca Estela Hernández Cruz, 955008000, blancahcruz@gmail.com
About this study
Official title: Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).
These patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.
Read the detailed description
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).
The drugs to be administered to patients are:
- JAK-type kinase inhibitors.
- Monoclonal antibodies against TNF.
- Soluble receptor against TNF.
- Biosimilar FAMEb.
- Rituximab.
- Abatacept.
- Drugs that block IL6.
A follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.
- Conditions
- Arthritis, Rheumatoid
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases 1 | Patients treated with JAK-type kinase inhibitors. | |
| Cases 2 | Patients treated with monoclonal antibodies against TNF. | |
| Cases 3 | Patients treated with soluble receptor against TNF. | |
| Cases 4 | Patients treated with FAME group biosimilars. | |
| Cases 5 | Patients treated with rituximab. | |
| Cases 6 | Patients treated with abatacept. | |
| Cases 7 | Patients treated with drugs that block the IL6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival study
To know the survival at 12, 24, 48, 60, 72 and 84 months to the synthetic directed anti-rheumatic drugs, disease modifiers (FAMEsd) and the biological disease modifying anti-rheumatic drugs (FAMEb) in patients with rheumatoid arthritis treated in routine.
Measured: Up to 60 weeks
Secondary outcomes (3)
Study of clinical characteristics.
To know the sociodemographic and clinical characteristics of the patients who receive FAMEsd and FAMEb in routine clinical practice at the HUVM.
Measured: Up to 60 weeks
Measure of the influence of comorbidities.
To assess the influence of comorbidities on drug persistence.
Measured: Up to 60 weeks
Number of participants who discontinued treatment due to serious adverse effects.
Failure due to serious adverse events, adverse events of special interest, emerging adverse events and minor adverse events that require discontinuation of the drug.
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Apr 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blanca Estela Hernández Cruz, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062421
- Sponsor's protocol ID
- FIS-FME-2020-01
- Acronym
- Arthritis
- Status last verified
- Apr 2021
- First submitted
- 10 Sep 2021
- Last updated
- 17 Nov 2021
- 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 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.
- ClinicalTrials.gov ID
- NCT05062421
- Acronym / sponsor ID
- Arthritis / FIS-FME-2020-01
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Sep 2021 (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.
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).
These patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.
Detailed description
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).
The drugs to be administered to patients are:
- JAK-type kinase inhibitors.
- Monoclonal antibodies against TNF.
- Soluble receptor against TNF.
- Biosimilar FAMEb.
- Rituximab.
- Abatacept.
- Drugs that block IL6.
A follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cases 1 | – | –Patients treated with JAK-type kinase inhibitors. |
| Cases 2 | – | –Patients treated with monoclonal antibodies against TNF. |
| Cases 3 | – | –Patients treated with soluble receptor against TNF. |
| Cases 4 | – | –Patients treated with FAME group biosimilars. |
| Cases 5 | – | –Patients treated with rituximab. |
| Cases 6 | – | –Patients treated with abatacept. |
| Cases 7 | – | –Patients treated with drugs that block the IL6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 18 years diagnosed with rheumatoid arthritis, who have been under treatment with at least one dose of the study drugs, whose treatment is followed by the rheumatology unit.
Key inclusion criteria (5 listed)
- Patients aged ≥18 years.
- With a diagnosis of Adult Rheumatoid Arthritis according to the 2010 ACR / EULAR criteria.
- Who have received at least one of the doses of the study drugs.
- In follow-up in the consultations of the UGC of Rheumatology of the HUVM.
- With at least two complete evaluations (baseline and final) of clinical variables.
Key exclusion criteria (2 listed)
- Patients where the medical records lack sufficient baseline and final variables to perform the analysis.
- Patients in whom more than 50% of the variables to be collected are missing in the data collection.
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
Survival study
Time frame: Up to 60 weeks
To know the survival at 12, 24, 48, 60, 72 and 84 months to the synthetic directed anti-rheumatic drugs, disease modifiers (FAMEsd) and the biological disease modifying anti-rheumatic drugs (FAMEb) in patients with rheumatoid arthritis treated in routine.
3 secondary outcomes
Study of clinical characteristics.
Time frame: Up to 60 weeks
Measure of the influence of comorbidities.
Time frame: Up to 60 weeks
Number of participants who discontinued treatment due to serious adverse effects.
Time frame: Up to 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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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.
Blanca Estela Hernández Cruz principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blanca Estela Hernández Cruz (955008000, blancahcruz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival study (time frame: Up to 60 weeks). 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 17 Nov 2021.