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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib | Experimental | Filgotinib 200 mg qd |
|
| Adalimumab | Active Comparator | Adalimumab 40 mg q2wk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Patients will receive pills of Filgotinib 200 mg qd for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| micro RNA (miRNA) | Fold increase in miRNA intensity measurements on the base-two logarithmic scale | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic profile | Fold increase in proteins intensity measurements on the base-two logarithmic scale | 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Adami, MD | Contact | +390458122574 | giovanni.adami@univr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Section, University of Verona | Recruiting | Verona | 37100 | Italy |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Adalimumab |
| Drug |
Patients will receive subcutaneous injections of Adalimumab 40 mg q2wk for 12 weeks |
|
| 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) | 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) | 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) | 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) | 12 weeks |
| American College of Rheumatology 50% Improvement (ACR50) | Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 12 | 12 weeks |
| Tender Joint Count | Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 12 | 12 weeks |
| Swollen Joint Count | Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 12 | 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) | 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) | 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) | 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) | 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) | 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |