Rheumatoid ArthritisPARROTFISHNCT05323591
Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France
An observational study of Rheumatoid Arthritis, run by Alfasigma S.p.A. at 17 sites in France.
Trial summary
An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- How many people
- 155 participants
- Where
- 17 sitesFrance
- Study dates
- 3 May 2022to 30 Mar 2026
- 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 consist of participants aged ≥ 18 years with moderate to severe active RA receiving filgotinib who will be enrolled in France.
Who may be able to join
- Participants aged ≥18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local treatment practices and product label for the first time.
- Female participants of childbearing potential must agree to use contraception while taking filgotinib as per product label.
- Participants must be willing and able to use an electronic device to complete the study PROs.
- Participant must sign and date the Informed Consent Form (ICF) before enrollment into the study.
Who cannot join
- Participation in any interventional or non-interventional study without prior approval from the Medical Lead. This does not preclude inclusion of participants enrolled to national registries.
- Female participant is pregnant or intending to become pregnant while taking filgotinib.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU Amiens Picardie site Nord
Amiens, 80054
CHU de Amiens Picardie
Amiens, 80054
Hopital Avicenne AP-HP
Bobigny, 93000
CHU Bordeaux
Bordeaux, 33000
CH de Cahors
Cahors, 46005
Clinique de l'Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300
Hopital Sud Francilien Corbeil Essonne
Corbeil-Essonnes, 91106
Hopital Roger Salengro
Lille, 59037
CHU de Nice
Nice, 06000
Centre Hospitalier Régional d'Orléans
Orléans, 45100
Hopital Saint Antoine
Paris, 75012
Hopital Cochin Service A
Paris, 75014
Hopital Robert Debre
Reims, 51092
CHU de Rouen
Rouen, 76000
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42000
CHU Toulouse
Toulouse, 31000
CHRU de Tours
Tours, 37044
About this study
Official title: A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years
An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Filgotinib
- Keywords
- filgotinib, safety, effectiveness, patient-reported outcome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called Jyseleca
Tablets are administered in accordance with the product label
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib | Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label. Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Persistence Rate
Treatment persistence rate at 24 months, defined as the percentage of participants continuing to receive filgotinib for 24 months from treatment initiation.
Measured: Month 24
Secondary outcomes (7)
Disease Activity: Percentage of Participants Achieving Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28[CRP]) ≤3.2 and/or Clinical Disease Activity Index (CDAI) ≤10
Measured: Up to 24 months
Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8
Measured: Up to 24 months
Number of Participants With Adverse Events and Serious Adverse Events
Measured: Up to 24 months
Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score
Measured: Up to 24 months
Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Measured: Up to 24 months
Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score
Measured: Up to 24 months
Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start3 May 2022
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfasigma Study Director, Study director, Alfasigma S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323591
- Sponsor's protocol ID
- GLPG0634-CL-424
- Other IDs
- 49028
- Acronym
- PARROTFISH
- Status last verified
- May 2026
- First submitted
- 5 Apr 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burmester GR, Galloway J, Bevers K, Avouac J, Romero-Yuste S, Caporali RF, Betteridge N, Van der Donckt C, Debray TPA, Tandjaoui Bouzid O, Verschueren P. Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies. Rheumatol Ther. 2026 Jul 31. doi: 10.1007/s40744-026-00874-x. Online ahead of print.
PubMed 42536126
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years
- ClinicalTrials.gov ID
- NCT05323591
- Acronym / sponsor ID
- PARROTFISH / GLPG0634-CL-424
- Conditions
- Rheumatoid Arthritis
- Keywords
- filgotinib, safety, effectiveness, patient-reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 Apr 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.
An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | – | Drug: FilgotinibParticipants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label. |
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 consist of participants aged ≥ 18 years with moderate to severe active RA receiving filgotinib who will be enrolled in France.
Key inclusion criteria (4 listed)
- Participants aged ≥18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local treatment practices and product label for the first time.
- Female participants of childbearing potential must agree to use contraception while taking filgotinib as per product label.
- Participants must be willing and able to use an electronic device to complete the study PROs.
- Participant must sign and date the Informed Consent Form (ICF) before enrollment into the study.
Key exclusion criteria (2 listed)
- Participation in any interventional or non-interventional study without prior approval from the Medical Lead. This does not preclude inclusion of participants enrolled to national registries.
- Female participant is pregnant or intending to become pregnant while taking filgotinib.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: JyselecaTablets are administered in accordance with the product label | Drug | Filgotinib |
Primary outcome
Treatment Persistence Rate
Time frame: Month 24
Treatment persistence rate at 24 months, defined as the percentage of participants continuing to receive filgotinib for 24 months from treatment initiation.
7 secondary outcomes
Disease Activity: Percentage of Participants Achieving Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28[CRP]) ≤3.2 and/or Clinical Disease Activity Index (CDAI) ≤10
Time frame: Up to 24 months
Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8
Time frame: Up to 24 months
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 24 months
Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score
Time frame: Up to 24 months
Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Time frame: Up to 24 months
Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score
Time frame: Up to 24 months
Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42536126Burmester GR, Galloway J, Bevers K, Avouac J, Romero-Yuste S, Caporali RF, Betteridge N, Van der Donckt C, Debray TPA, Tandjaoui Bouzid O, Verschueren P. Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies. Rheumatol Ther. 2026 Jul 31. doi: 10.1007/s40744-026-00874-x. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Alfasigma Study Director study director
Alfasigma S.p.A.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Alfasigma S.p.A. at 17 sites in France.
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 4 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Persistence Rate (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323591, which also lists 1 linked publication.
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 22 May 2026.