A Phase 3 interventional study of Filgotinib and Placebo to match filgotinib in Rheumatoid Arthritis, sponsored by Alfasigma S.p.A.. Completed at 345 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Alfasigma S.p.A. · Phase 3, Interventional, and Treatment
Among 17 studies testing GLPG0634 in Arthritis, Rheumatoid — 4 open to participants now, 4 under way, none of them phase 3. GLPG0634 · Arthritis, Rheumatoid.
Among the 17 studies testing GLPG0634 in Arthritis, Rheumatoid, this one has the largest enrollment, is the only one that started in 2017, is one of 5 in phase 3, and was the 9th registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 2,731 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →4 of the 17 studies testing GLPG0634 in Arthritis, Rheumatoid are open now, in 3 countries. Each count lists the studies.
GLPG0634: first EMA approval 2020. What it is approved for, and how studies give it, is on its page →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2017.
Median enrollment 287 across the 17 interventional studies. Of the 12 that completed or were terminated, 10 (83%) have results posted.
12 of 17 have an industry lead sponsor. The 8 most frequent:
Alfasigma S.p.A. is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Alfasigma S.p.A. has 3 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing GLPG0634 in Arthritis, Rheumatoid, from their registry updates:
Nothing recorded among them since 2026-09-25.
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
Key Inclusion Criteria:
Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:
Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
Drug: Filgotinib · Drug: Placebo to match filgotinib
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
Drug: Filgotinib · Drug: Placebo to match filgotinib
Filgotinib 200 mg for up to 6 years
Drug: Filgotinib
Filgotinib 100 mg for up to 6 years
Drug: Filgotinib
Tablet(s) administered orally once daily
Also known as: GS-6034, GLPG0634
Tablet(s) administered orally once daily
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event. A TEAE was any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or premature discontinuation of study drug.
Time frame: Day 1 to Week 376 (end of study)
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
Time frame: Day 1 to Week 376 (end of study)
Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
Time frame: Day 1 to Week 376 (end of study)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Time frame: Baseline and At Week 312
Change From Baseline in Pulse Rate
Pulse rate was collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Time frame: Baseline and At Week 312
Change From Baseline in Respiration Rate
Changes in respiration rates were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
Time frame: Baseline and At Week 312
Percentage of Participants Who Achieved American College of Rheumatology (ACR) for 20, 50 and 70
ACR is the improvement from the parent study baseline in swollen joint count (66 joints) where joints were classified as swollen or not swollen, tender joint count (68) where scoring was performed on different aspects of tenderness, and improvement in 3 of 5 items: Subject pain assessment: pain score form Health Assessment Questionnaire Disability Index (HAQ-DI; scale 0=no difficulty to 3=unable to do) was calculated; Subject global assessment of disease activity: a horizontal visual analog scale (VAS; 0=best to 10=worst) was used to assess the participants arthritis status; Physicians global assessment of disease activity: A horizontal VAS (0=best to 10=worst) was used; Subject's assessment of physical function: HAQ-DI (scale 0=no difficulty to 3=unable to do) was used to calculate participants physical function and Acute-phase reactant value: C-reactive level protein is measured. ACR20, 50 and 70 responders were participants with at least 20%, 50% and 70% achievement respectively.
Time frame: At Week 312
An open-label, multicenter, long-term extension study (LTE) that assessed safety and efficacy of filgotinib in participants with rheumatoid arthritis. Eligible participants from studies GS-US-417-0301(NCT02889796), GS-US-417-0302(NCT02873936), and GS-US-417-0303(NCT02886728) were enrolled. Participants who had received a fixed dose of filgotinib in the parent studies continued the same dosage, while those who had received placebo were randomized to receive either 100 mg or 200 mg of filgotinib.
| Milestone | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| Started | 1195 | 336 | 864 | 336 |
| Completed | 572 | 158 | 400 | 129 |
| Not completed | 623 | 178 | 464 | 207 |
| Withdrew: Withdrawal by subject | 154 | 42 | 118 | 64 |
| Withdrew: Adverse event | 147 | 45 | 121 | 41 |
| Withdrew: Physician decision | 63 | 25 | 43 | 22 |
| Withdrew: Lost to follow-up | 41 | 11 | 40 | 22 |
| Withdrew: Death | 37 | 4 | 20 | 11 |
| Withdrew: Pregnancy | 7 | 2 | 3 | 2 |
| Withdrew: Study terminated by sponsor | 160 | 43 | 105 | 42 |
| Withdrew: Non-compliance with study drug | 6 | 4 | 7 | 1 |
| Withdrew: Protocol deviation | 7 | 1 | 6 | 2 |
| Withdrew: Missing | 1 | 0 | 0 | 0 |
| Withdrew: Participants did not receive study treatment | 0 | 1 | 1 | 0 |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant after administration of an investigational product, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or significant medical event. A TEAE was any AE with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or premature discontinuation of study drug.
| Participants | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| TEAE | 1071 | 300 | 769 | 283 |
| TESAE | 288 | 74 | 212 | 87 |
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
| Participants | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| ALT (Increased) - Grade 1 | 394 | 98 | 274 | 106 |
| ALT (Increased) - Grade 2 | 49 | 16 | 38 | 9 |
| ALT (Increased) - Grade 3 | 18 | 7 | 13 | 5 |
| ALT (Increased) - Grade 4 | 0 | 1 | 0 | 0 |
| AST (Increased) - Grade 1 | 414 | 98 | 275 | 109 |
| AST (Increased) - Grade 2 | 33 | 10 | 27 | 5 |
| AST (Increased) - Grade 3 | 12 | 2 | 8 | 3 |
| AST (Increased) - Grade 4 | 0 | 1 | 0 | 0 |
| Bilirubin (Increased) - Grade 1 | 63 | 15 | 34 | 21 |
| Bilirubin (Increased) - Grade 2 | 19 | 4 | 8 | 6 |
| Bilirubin (Increased) - Grade 3 | 0 | 1 | 1 | 0 |
| Bilirubin (Increased) - Grade 4 | 0 | 0 | 0 | 0 |
| Creatine Kinase (Increased) - Grade 1 | 415 | 138 | 225 | 99 |
| Creatine Kinase (Increased) - Grade 2 | 83 | 14 | 48 | 18 |
| Creatine Kinase (Increased) - Grade 3 | 20 | 8 | 12 | 3 |
| Creatine Kinase (Increased) - Grade 4 | 9 | 0 | 6 | 4 |
| Creatinine (Increased) - Grade 1 | 56 | 11 | 36 | 14 |
| Creatinine (Increased) - Grade 2 | 47 | 23 | 38 | 14 |
| Creatinine (Increased) - Grade 3 | 8 | 1 | 5 | 1 |
| Creatinine (Increased) - Grade 4 | 0 | 0 | 0 | 0 |
| Phosphate (Decreased) - Grade 1 | 0 | 0 | 0 | 0 |
| Phosphate (Decreased) - Grade 2 | 87 | 25 | 42 | 18 |
| Phosphate (Decreased) - Grade 3 | 35 | 3 | 13 | 7 |
| Phosphate (Decreased) - Grade 4 | 0 | 0 | 0 | 0 |
Treatment-emergent laboratory abnormalities were defined as an increase of at least one toxicity grade from the LTE baseline at any post-baseline time point, up to and including 30 days after the last study drug dose for subjects who permanently discontinued treatment. Abnormalities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03, as Grade 1 (mild), Grade 2 (moderate), and Grade 3 (severe) and Grade 4 (life-threatening). Blood samples were collected by venipuncture in the arm at the specified time points. The laboratory values outside the normal range were flagged and the clinical relevance was determined by Medical Monitor and Clinical Investigators.
| Participants | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| Hemoglobin (Anemia) - Grade 1 | 247 | 60 | 165 | 60 |
| Hemoglobin (Anemia) - Grade 2 | 86 | 29 | 67 | 30 |
| Hemoglobin (Anemia) - Grade 3 | 23 | 7 | 13 | 10 |
| Hemoglobin (Anemia) - Grade 4 | 0 | 0 | 0 | 0 |
| Hemoglobin (Increased) - Grade 1 | 30 | 11 | 12 | 8 |
| Hemoglobin (Increased) - Grade 2 | 0 | 0 | 1 | 0 |
| Hemoglobin (Increased) - Grade 3 | 0 | 0 | 0 | 0 |
| Hemoglobin (Increased) - Grade 4 | 0 | 0 | 0 | 0 |
| Leukocytes (Decreased) - Grade 1 | 236 | 76 | 116 | 45 |
| Leukocytes (Decreased) - Grade 2 | 120 | 27 | 56 | 22 |
| Leukocytes (Decreased) - Grade 3 | 8 | 1 | 6 | 2 |
| Leukocytes (Decreased) - Grade 4 | 0 | 0 | 0 | 0 |
| Lymphocytes (Decreased) - Grade 1 | 72 | 23 | 51 | 14 |
| Lymphocytes (Decreased) - Grade 2 | 283 | 58 | 144 | 52 |
| Lymphocytes (Decreased) - Grade 3 | 63 | 16 | 31 | 17 |
| Lymphocytes (Decreased) - Grade 4 | 0 | 0 | 0 | 0 |
| Lymphocytes (Increased) - Grade 1 | 0 | 0 | 0 | 0 |
| Lymphocytes (Increased) - Grade 2 | 28 | 11 | 17 | 8 |
| Lymphocytes (Increased) - Grade 3 | 0 | 0 | 0 | 0 |
| Lymphocytes (Increased) - Grade 4 | 0 | 0 | 0 | 0 |
| Platelets (Decreased) - Grade 1 | 52 | 11 | 38 | 12 |
| Platelets (Decreased) - Grade 2 | 3 | 0 | 1 | 0 |
| Platelets (Decreased) - Grade 3 | 1 | 0 | 1 | 0 |
| Platelets (Decreased) - Grade 4 | 0 | 0 | 0 | 0 |
SBP and DBP were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
| millimeters of mercury (mmHg) | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| SBP | 2 ± 14.1 | 1 ± 12.6 | 2 ± 14.4 | 3 ± 12.9 |
| DBP | 1 ± 9.9 | 0 ± 9.5 | 1 ± 9.6 | 2 ± 9.0 |
Pulse rate was collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
| beats/minute | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| Change From Baseline in Pulse Rate | 2 ± 9.7 | 0 ± 10.4 | 1 ± 10.7 | 1 ± 9.4 |
Changes in respiration rates were collected at specified timepoints after participants had remained in a resting position for at least 5 minutes. The LTE baseline value was defined as the last available value collected on or prior to the date of the first dose of any study drug in the LTE. Change from the LTE baseline to a postbaseline visit was defined as the postbaseline value minus the LTE baseline value.
| breaths/min | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| Change From Baseline in Respiration Rate | 0 ± 2.1 | 0 ± 2.4 | 0 ± 2.0 | 0 ± 2.8 |
ACR is the improvement from the parent study baseline in swollen joint count (66 joints) where joints were classified as swollen or not swollen, tender joint count (68) where scoring was performed on different aspects of tenderness, and improvement in 3 of 5 items: Subject pain assessment: pain score form Health Assessment Questionnaire Disability Index (HAQ-DI; scale 0=no difficulty to 3=unable to do) was calculated; Subject global assessment of disease activity: a horizontal visual analog scale (VAS; 0=best to 10=worst) was used to assess the participants arthritis status; Physicians global assessment of disease activity: A horizontal VAS (0=best to 10=worst) was used; Subject's assessment of physical function: HAQ-DI (scale 0=no difficulty to 3=unable to do) was used to calculate participants physical function and Acute-phase reactant value: C-reactive level protein is measured. ACR20, 50 and 70 responders were participants with at least 20%, 50% and 70% achievement respectively.
| percentage of participants | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| ACR 20 | 93.3 (90.7 to 96.0) | 89.8 (83.3 to 96.3) | 86.6 (82.4 to 90.9) | 77.0 (68.3 to 85.7) |
| ACR 50 | 75.4 (70.9 to 79.9) | 81.3 (72.9 to 89.6) | 69.3 (63.6 to 75.0) | 59.4 (49.3 to 69.5) |
| ACR 70 | 57.6 (52.5 to 62.7) | 59.2 (48.9 to 69.4) | 49.6 (43.5 to 55.8) | 42.2 (32.1 to 52.2) |
Collected over Day 1 to Week 376 (end of study). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Filgotinib 200 mg: With Prior Filgotinib Exposure | 45/1,195 (3.8%) | 288/1,195 (24.1%) | 1,071/1,195 (89.6%) |
| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 6/335 (1.8%) | 74/335 (22.1%) | 300/335 (89.6%) |
| Filgotinib 100 mg: With Prior Filgotinib Exposure | 26/863 (3%) | 212/863 (24.6%) | 769/863 (89.1%) |
| Filgotinib 100 mg: Without Prior Filgotinib Exposure | 13/336 (3.9%) | 87/336 (25.9%) | 283/336 (84.2%) |
| Event | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| COVID-19Infections and infestations | 26/1195 | 6/335 | 10/863 | 6/336 |
| PneumoniaInfections and infestations | 16/1195 | 4/335 | 4/863 | 6/336 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 11/1195 | 1/335 | 11/863 | 5/336 |
| Atrial fibrillationCardiac disorders | 5/1195 | 4/335 | 3/863 | 1/336 |
| COVID-19 pneumoniaInfections and infestations | 8/1195 | 3/335 | 7/863 | 4/336 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 1/1195 | 3/335 | 4/863 | 3/336 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 4/1195 | 3/335 | 1/863 | 0/336 |
| SepsisInfections and infestations | 4/1195 | 0/335 | 0/863 | 3/336 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 2/1195 | 0/335 | 7/863 | 0/336 |
| Transient ischaemic attackNervous system disorders | 1/1195 | 0/335 | 6/863 | 1/336 |
| Event | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure |
|---|---|---|---|---|
| COVID-19Infections and infestations | 219/1195 | 58/335 | 132/863 | 62/336 |
| NasopharyngitisInfections and infestations | 157/1195 | 38/335 | 130/863 | 33/336 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 110/1195 | 40/335 | 120/863 | 41/336 |
| Upper respiratory tract infectionInfections and infestations | 131/1195 | 44/335 | 99/863 | 40/336 |
| HypertensionVascular disorders | 90/1195 | 38/335 | 91/863 | 35/336 |
| Urinary tract infectionInfections and infestations | 126/1195 | 37/335 | 87/863 | 37/336 |
| HeadacheNervous system disorders | 93/1195 | 33/335 | 72/863 | 24/336 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 79/1195 | 26/335 | 78/863 | 25/336 |
| BronchitisInfections and infestations | 93/1195 | 21/335 | 53/863 | 19/336 |
| Latent tuberculosisInfections and infestations | 67/1195 | 14/335 | 45/863 | 26/336 |
Safety Analysis Set included all participants who enrolled in the LTE and received at least 1 dose of filgotinib in the LTE.
| Age, Continuous(years) | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure | Total |
|---|---|---|---|---|---|
| Mean | 53 ± 13.2 | 54 ± 12.1 | 54 ± 12.4 | 55 ± 13.9 | 54 ± 12.9 |
| Sex: Female, Male(Participants) | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure | Total |
|---|---|---|---|---|---|
| Female | 960 | 267 | 699 | 272 | 2198 |
| Male | 235 | 68 | 164 | 64 | 531 |
| Ethnicity (NIH/OMB)(Participants) | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 221 | 69 | 150 | 72 | 512 |
| Not Hispanic or Latino | 968 | 265 | 704 | 264 | 2201 |
| Unknown or Not Reported | 6 | 1 | 9 | 0 | 16 |
| Race (NIH/OMB)(Participants) | Filgotinib 200 mg: With Prior Filgotinib Exposure | Filgotinob 200 mg: Without Prior Filgotinob Exposure | Filgotinib 100 mg: With Prior Filgotinib Exposure | Filgotinib 100 mg: Without Prior Filgotinib Exposure | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 82 | 25 | 58 | 27 | 192 |
| Asian | 251 | 60 | 186 | 60 | 557 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 32 | 13 | 21 | 20 | 86 |
| White | 817 | 233 | 585 | 226 | 1861 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 12 | 4 | 13 | 3 | 32 |
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Studies of the drug tested here: GLPG0634