Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05323591




Registration number
NCT05323591
Ethics application status
Date submitted
5/04/2022
Date registered
12/04/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France
Scientific title
A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years
Secondary ID [1] 0 0
49028
Secondary ID [2] 0 0
GLPG0634-CL-424
Universal Trial Number (UTN)
Trial acronym
PARROTFISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib

Filgotinib - Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label.


Treatment: Drugs: Filgotinib
Tablets are administered in accordance with the product label
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Persistence Rate
Timepoint [1] 0 0
Month 24
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Disease Activity: Percentage of Participants Achieving DAS28(CRP) =2.6 and/or CDAI =2.8
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Number of Participants With Adverse Events and Serious Adverse Events
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)
Timepoint [7] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Amiens
Country [2] 0 0
France
State/province [2] 0 0
Bobigny
Country [3] 0 0
France
State/province [3] 0 0
Bordeaux
Country [4] 0 0
France
State/province [4] 0 0
Cahors
Country [5] 0 0
France
State/province [5] 0 0
Caluire-et-Cuire
Country [6] 0 0
France
State/province [6] 0 0
Cholet
Country [7] 0 0
France
State/province [7] 0 0
Corbeil-Essonnes
Country [8] 0 0
France
State/province [8] 0 0
Lille
Country [9] 0 0
France
State/province [9] 0 0
Marseille
Country [10] 0 0
France
State/province [10] 0 0
Nice
Country [11] 0 0
France
State/province [11] 0 0
Orléans
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Reims
Country [14] 0 0
France
State/province [14] 0 0
Rouen
Country [15] 0 0
France
State/province [15] 0 0
Saint-Étienne
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
France
State/province [17] 0 0
Tours

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alfasigma S.p.A.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT05323591
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Alfasigma Study Director
Address 0 0
Alfasigma S.p.A.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05323591