Rheumatoid ArthritisPhase 4FILRANCT06527534
Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
A Phase 4 study testing Filgotinib and Adalimumab in people with Rheumatoid Arthritis, run by Universita di Verona at 1 site in Italy.
Trial summary
Purpose: The study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients. Study Design: This is a single-center, prospective randomized study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Filgotinib and Adalimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2024to 15 Sep 2025
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein [DAS28 CRP] >5.1 and/or Clinical Disease Activity Index [CDAI] >22)
- Age > 18, <65 years
- Patients for whom treatment with filgotinib or adalimumab might be planned
Who cannot join
- History of major cardiovascular events or stroke
- History of venous thromboembolism
- Active smokers or past smokers >10 pack/years
- History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)
- Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)
- Chronic treatment with moderate to high dose of glucocorticoids (≥7.5 mg/day of prednisone equivalent for more than 3 months prior to enrollment), short term (<3 months) will be accepted if tapered, as clinically feasible, to <7.5 mg/day before enrollment)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rheumatology Section, University of Verona
Verona, 37100
Giovanni Adami, MD, +390458122574, giovanni.adami@univr.it
About this study
Official title: Exploring the Effects of Filgotinib, an Oral JAK-1 Selective Inhibitor, Proteomic Profile and Micro-RNA Expression in Peripheral Blood Mononuclear Cell (PBMC) of Patients With Active Rheumatoid Arthritis (RA)
Purpose:
The study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients.
Study Design:
This is a single-center, prospective randomized study.
Read the detailed description
Population:
The study will include 30 patients with active rheumatoid arthritis: 15 patients treated with Filgotinib. 15 patients treated with Adalimumab (used as a comparison group).
Procedures:
Participants will have blood samples taken at the start and then every 4 weeks up to 12 weeks. These samples will be used to analyze changes in proteins and micro-RNA. Participants will continue their regular rheumatoid arthritis treatment during the study.
Primary Objective:
To observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib.
Secondary Objectives:
Compare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib.
Safety and Data Management:
Adverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws.
Study Duration:
Recruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Filgotinib, Adalimumab
- Keywords
- RA
- 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
Patients will receive pills of Filgotinib 200 mg qd for 12 weeks
AdalimumabDrug
Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib | Experimental | Filgotinib 200 mg qd Receives: Drug: Filgotinib |
| Adalimumab | Active comparator | Adalimumab 40 mg q2wk Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
micro RNA (miRNA)
Fold increase in miRNA intensity measurements on the base-two logarithmic scale
Measured: 12 weeks
Secondary outcomes (14)
Proteomic profile
Fold increase in proteins intensity measurements on the base-two logarithmic scale
Measured: 12 weeks
American College of Rheumatology 20% Improvement (ACR20)
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Measured: 12 weeks
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 (range 0.000 - 3.000, higher numbers are worse)
Measured: 12 weeks
Disease Activity Score 28 joints measured with CRP (DAS28-CRP)
Change From Baseline in Disease Activity Score 28 joints measured with CRP (DAS28-CRP) at Weeks 12 (range 0.96 - 8.61, higher numbers are worse)
Measured: 12 weeks
36-Item Short Form Survey (SF-36)
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 (range 0 - 100, lower numbers are worse)
Measured: 12 weeks
Functional Assessment of Chronic Illness Therapy (FACIT)
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 (range 0 - 52, lower numbers are worse)
Measured: 12 weeks
American College of Rheumatology 50% Improvement (ACR50)
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12
Measured: 12 weeks
Tender Joint Count
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12
Measured: 12 weeks
Swollen Joint Count
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12
Measured: 12 weeks
Subject's Global Assessment of Disease Activity (SGA)
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 12 (range 0 - 10, higher numbers are worse)
Measured: 12 weeks
Physician's Global Assessment of Disease Activity (PGA)
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 12 (range 0 - 10, higher numbers are worse)
Measured: 12 weeks
Pain on Numeric Rating Scale (NRS)
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 12 (range 0 - 10, higher numbers are worse)
Measured: 12 weeks
Clinical Disease Activity Index (CDAI)
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 12 (range 0 - 76, higher numbers are worse)
Measured: 12 weeks
Simplified Disease Activity Index (SDAI)
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 12 (range 0 - 91, higher numbers are worse)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start15 Jul 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Sep 2025 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Adami, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527534
- Sponsor's protocol ID
- 215CET - FILRA
- Acronym
- FILRA
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Filgotinib, an Oral JAK-1 Selective Inhibitor, Proteomic Profile and Micro-RNA Expression in Peripheral Blood Mononuclear Cell (PBMC) of Patients With Active Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT06527534
- Acronym / sponsor ID
- FILRA / 215CET - FILRA
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 30 Jul 2024 (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.
Purpose:
The study aims to investigate how Filgotinib affects proteins and micro-RNA in the blood of patients with rheumatoid arthritis. This could help understand its impact on inflammation and bone health in these patients.
Study Design:
This is a single-center, prospective randomized study.
Detailed description
Population:
The study will include 30 patients with active rheumatoid arthritis: 15 patients treated with Filgotinib. 15 patients treated with Adalimumab (used as a comparison group).
Procedures:
Participants will have blood samples taken at the start and then every 4 weeks up to 12 weeks. These samples will be used to analyze changes in proteins and micro-RNA. Participants will continue their regular rheumatoid arthritis treatment during the study.
Primary Objective:
To observe changes in the metabolic profile (proteins and micro-RNA) in patients treated with Filgotinib.
Secondary Objectives:
Compare the metabolic profile changes between Filgotinib and Adalimumab. Identify metabolic factors associated with early clinical response to Filgotinib.
Safety and Data Management:
Adverse events will be monitored and reported. Patient confidentiality will be maintained according to privacy laws.
Study Duration:
Recruitment: 16 weeks. Patient involvement: 12 weeks. Total study duration: 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | Experimental | Drug: FilgotinibFilgotinib 200 mg qd |
| Adalimumab | Active comparator | Drug: AdalimumabAdalimumab 40 mg q2wk |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria with active disease (Disease Activity Score 28-joints C-reactive protein [DAS28 CRP] >5.1 and/or Clinical Disease Activity Index [CDAI] >22)
- Age > 18, <65 years
- Patients for whom treatment with filgotinib or adalimumab might be planned
Key exclusion criteria (6 listed)
- History of major cardiovascular events or stroke
- History of venous thromboembolism
- Active smokers or past smokers >10 pack/years
- History of fragility fractures or severe osteoporosis (T score at total hip or femoral neck or lumbar spine ≤3.5)
- Treatment with bone-active medications (estrogens, bisphosphonates, denosumab, teriparatide, romosozumab)
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 |
|---|---|---|
| FilgotinibPatients will receive pills of Filgotinib 200 mg qd for 12 weeks | Drug | Filgotinib |
| AdalimumabPatients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks | Drug | Adalimumab |
Primary outcome
micro RNA (miRNA)
Time frame: 12 weeks
Fold increase in miRNA intensity measurements on the base-two logarithmic scale
14 secondary outcomes
Proteomic profile
Time frame: 12 weeks
American College of Rheumatology 20% Improvement (ACR20)
Time frame: 12 weeks
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: 12 weeks
Disease Activity Score 28 joints measured with CRP (DAS28-CRP)
Time frame: 12 weeks
36-Item Short Form Survey (SF-36)
Time frame: 12 weeks
Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: 12 weeks
American College of Rheumatology 50% Improvement (ACR50)
Time frame: 12 weeks
Tender Joint Count
Time frame: 12 weeks
Swollen Joint Count
Time frame: 12 weeks
Subject's Global Assessment of Disease Activity (SGA)
Time frame: 12 weeks
Physician's Global Assessment of Disease Activity (PGA)
Time frame: 12 weeks
Pain on Numeric Rating Scale (NRS)
Time frame: 12 weeks
Clinical Disease Activity Index (CDAI)
Time frame: 12 weeks
Simplified Disease Activity Index (SDAI)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Filgotinib and Adalimumab in people with Rheumatoid Arthritis, run by Universita di Verona at 1 site in Italy.
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 3 inclusion and 6 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 1 Aug 2024. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Giovanni Adami, MD (+390458122574, giovanni.adami@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
micro RNA (miRNA) (time frame: 12 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 1 Aug 2024.