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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001496-75 | EudraCT Number |
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The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-9876 - 30 mg | Experimental | GS-9876 30 mg + filgotinib placebo for 12 weeks |
|
| GS-9876 - 10 mg | Experimental | GS-9876 10 mg + filgotinib placebo for 12 weeks |
|
| Filgotinib | Experimental | Filgotinib + GS-9876 placebo for 12 weeks |
|
| Placebo | Placebo Comparator | GS-9876 placebo + filgotinib placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9876 | Drug | One tablet administered orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 | Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. | Baseline; Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12 | American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omega Research Consultants | DeBary | Florida | 32713 | United States | ||
| Sarasota Arthritis Research Center |
140 participants were screened.
Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 21 September 2016. The last study visit occurred on 20 September 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | GS-9876 30 mg | GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| FG001 | GS-9876 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Apr 8, 2016 | Jul 18, 2018 |
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| Filgotinib |
| Drug |
Two tablets administered orally once daily |
|
| GS-9876 placebo | Drug | One tablet administered orally once daily |
|
| Filgotinib placebo | Drug | Two tablets administered orally once daily |
|
| Methotrexate | Drug | Background therapy with methotrexate administered orally or parenterally once weekly |
|
| Week 12 |
| Percentage of Participants Who Achieved ACR50 Improvement at Week 12 | ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP. | Week 12 |
| Percentage of Participants Who Achieved ACR70 Improvement at Week 12 | ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP. | Week 12 |
| Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing. | Baseline; Week 12 |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Medical Associates of North Georgia | Canton | Georgia | 30114 | United States |
| Center For Arthritis and Osteoporosis | Elizabethtown | Kentucky | 42701 | United States |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Accurate Clinical Management - Najam | Houston | Texas | 77084 | United States |
| Accurate Clinical Research Inc. | Stafford | Texas | 77477 | United States |
| Medical Center Research LLC | Webster | Texas | 77598 | United States |
| MHAT-Plovdiv AD | Plovdiv | 4000 | Bulgaria |
| Umhat Kaspela | Plovdiv | 4003 | Bulgaria |
| NMTH Tsar Boris III | Sofia | 1233 | Bulgaria |
| A-Shine s.r.o. | Pilsen | 31200 | Czechia |
| Medical Plus, S.R.O. | Uherské Hradiště | 68601 | Czechia |
| LLC Arensia Exploratory Medicine | Tbilisi | 0112 | Georgia |
| ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital | Chisinau | MD-2025 | Moldova |
| ClinicMed Badurski i wspolnicy Spolka Jawna | Bialystok | 15-879 | Poland |
| Kharkiv City Hospital 8 | Kharkiv | 140176 | Ukraine |
| Medical Center_Clinic of International Institute of clinical Studies | Kyiv | 2068 | Ukraine |
GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly
| FG002 | Filgotinib | Filgotinib 2 x 100 mg tablets orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| FG003 | Placebo | GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | GS-9876 30 mg | GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| BG001 | GS-9876 10 mg | GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| BG002 | Filgotinib | Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| BG003 | Placebo | GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Disease Activity Score 28 C-Reactive Protein (DAS28 CRP) | Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Health Assessment Questionnaire Disease Index (HAQ-DI) | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 | Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. | Participants in the Full Analysis Set (participants who received at least 1 dose of study drug) with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Week 12 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12 | American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP). | Full Analysis Set | Posted | Number | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved ACR50 Improvement at Week 12 | ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP. | Full Analysis Set | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved ACR70 Improvement at Week 12 | ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP. | Full Analysis Set | Posted | Number | percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Week 12 |
|
Up to 12 weeks + 30 days
Safety Analysis Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GS-9876 30 mg | GS-9876 30 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly | 0 | 20 | 0 | 20 | 7 | 20 |
| EG001 | GS-9876 10 mg | GS-9876 10 mg tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly | 0 | 20 | 0 | 20 | 8 | 20 |
| EG002 | Filgotinib | Filgotinib 2 x 100 mg tablet orally once daily + GS-9876 placebo tablet orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly | 0 | 21 | 0 | 21 | 4 | 21 |
| EG003 | Placebo | GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly | 0 | 22 | 0 | 22 | 1 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypermetropia | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Jun 27, 2016 | Jul 18, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Jul 11, 2016 | Jul 18, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2017 | Jul 18, 2018 | SAP_003.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Ukraine |
|
| Poland |
|
| Moldova |
|
| Georgia |
|
| Bulgaria |
|
| LS Means of Differences |
| 0.40 |
| 2-Sided |
| 95 |
| - 0.36 |
| 1.16 |
| Superiority |
| Cochran-Mantel-Haenszel | 0.002 | LS Means of Differences | - 1.18 | 2-Sided | 95 | - 1.92 | - 0.43 | Superiority |
| OG003 | Placebo | GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
|
|
|
GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
|
|
|
GS-9876 placebo tablet orally once daily + Filgotinib placebo 2 tablets orally once daily for 12 weeks Background therapy with methotrexate orally or parenterally once weekly |
|
|
|
| OG003 | Placebo | GS-9876 placebo tablet orally once daily + filgotinib placebo 2 tablets orally once daily for 12 weeks and background therapy with methotrexate orally or parenterally once weekly |
|
|
|