Adults 18 to 75, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12Primary· Week 12
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); health assessment questionnaire-disability index (HAQ-DI) inclusive of activit
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
76.8
57.2 – 96.5
Filgotinib 100 mg (Main Study)
63.2
38.8 – 87.5
Adalimumab (Main Study)
67.2
36.2 – 98.3
Placebo (Main Study)
44.8
22.8 – 66.7
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16Secondary· Baseline, 4, and 16 weeks
PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA \[using VAS on a scale of 0=very well to 100=very poor\]; PhGADA \[using VAS on a scale of 0=no disease activity to 100=maximum disease activity\];36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\];TJC68;SJC66; leeds enthesitis index(LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates high
Baseline
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
5.9
± 1.32
Filgotinib 100 mg (Main Study)
5.3
± 0.99
Adalimumab 40 mg (Main Study)
5.5
± 1.05
Placebo (Main Study)
5.5
± 1.05
Change From Baseline at Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1.5
± 0.62
Filgotinib 100 mg (Main Study)
-1.0
± 0.99
Adalimumab 40 mg (Main Study)
-1.3
± 0.66
Placebo (Main Study)
-0.3
± 0.80
Change From Baseline at Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-2.5
± 1.26
Filgotinib 100 mg (Main Study)
-2.0
± 1.48
Adalimumab 40 mg (Main Study)
-2.6
± 1.37
Placebo (Main Study)
-1.0
± 1.04
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16Secondary· Weeks 4, 8, 12, and 16
MDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the MDA if the participant fulfills at least 5 of the following 7 criteria: TJC68 ≤1; SJC66 ≤1; Psoriatic arthritis disease activity score (PASI) ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ra
Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
21.1
0.1 – 42.0
Filgotinib 100 mg (Main Study)
16.7
0.0 – 36.7
Adalimumab 40 mg (Main Study)
22.2
0.0 – 54.9
Placebo (Main Study)
5.0
0.0 – 17.1
Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
26.3
3.9 – 48.7
Filgotinib 100 mg (Main Study)
31.6
8.0 – 55.1
Adalimumab 40 mg (Main Study)
22.2
0.0 – 54.9
Placebo (Main Study)
15.8
0.0 – 34.8
Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
44.4
18.7 – 70.2
Filgotinib 100 mg (Main Study)
47.4
22.3 – 72.5
Adalimumab 40 mg (Main Study)
37.5
0.0 – 77.3
Placebo (Main Study)
15.8
0.0 – 34.8
Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
27.8
4.3 – 51.2
Filgotinib 100 mg (Main Study)
36.8
12.5 – 61.2
Adalimumab 40 mg (Main Study)
37.5
0.0 – 77.3
Placebo (Main Study)
20.0
0.0 – 40.0
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16Secondary· Weeks 4, 8, 12, and 16
VLDA is a measure to indicate disease remission, and is based on a composite score of 7 domains. A participant is considered as having achieved the VLDA if the participant fulfills all the seven criteria: TJC68 ≤1; SJC66 ≤1; PASI score ≤1 for participants with psoriasis covering BSA \<3% \[PASI evaluates the severity and extent of psoriasis. In PASI, body is divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area is assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. The total score ranges from 0 (no disease) to 72 (maximal disease)\]; P
Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
5.3
0.0 – 17.9
Filgotinib 100 mg (Main Study)
0
0.0 – 2.8
Adalimumab 40 mg (Main Study)
0
0.0 – 5.6
Placebo (Main Study)
0
0.0 – 2.5
Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
5.3
0.0 – 17.9
Filgotinib 100 mg (Main Study)
0
0.0 – 2.6
Adalimumab 40 mg (Main Study)
0
0.0 – 5.6
Placebo (Main Study)
10.5
0.0 – 27.0
Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
11.1
0.0 – 28.4
Filgotinib 100 mg (Main Study)
5.3
0.0 – 17.9
Adalimumab 40 mg (Main Study)
12.5
0.0 – 41.7
Placebo (Main Study)
5.3
0.0 – 17.9
Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
5.6
0.0 – 18.9
Filgotinib 100 mg (Main Study)
10.5
0.0 – 27.0
Adalimumab 40 mg (Main Study)
11.1
0.0 – 37.2
Placebo (Main Study)
0
0.0 – 2.5
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16Secondary· Baseline, 2, 4, 8, 12, and 16 weeks
DAPSA is calculated by summing the following components: TJC68; SJC66; PGADA \[using VAS on a scale of 0 (very well) to 100 very poor)\]; PGAPI \[using a VAS on a scale of 0 (no pain) to 100 (serious pain)\] and CRP. DAPSA scores 0-4 = remission, 5-14 = low disease activity, 15-28 = moderate disease activity, and \>28 = high disease activity. The DAPSA score has a lower bound of 0 and has no upper bound. A higher DAPSA score indicated more active disease activity. A negative change from baseline indicates improvement.
Baseline
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
48.0
± 25.55
Filgotinib 100 mg (Main Study)
30.3
± 10.43
Adalimumab 40 mg (Main Study)
38.8
± 20.82
Placebo (Main Study)
33.8
± 17.55
Change From Baseline at Week 2
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-12.5
± 11.96
Filgotinib 100 mg (Main Study)
-5.3
± 9.12
Adalimumab 40 mg (Main Study)
-10.9
± 8.39
Placebo (Main Study)
-7.5
± 11.72
Change From Baseline at Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-19.3
± 14.30
Filgotinib 100 mg (Main Study)
-9.4
± 12.13
Adalimumab 40 mg (Main Study)
-14.2
± 10.45
Placebo (Main Study)
-6.5
± 8.41
Change From Baseline at Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-28.4
± 15.67
Filgotinib 100 mg (Main Study)
-12.4
± 11.06
Adalimumab 40 mg (Main Study)
-17.8
± 12.96
Placebo (Main Study)
-10.6
± 8.87
Change From Baseline at Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-27.4
± 17.09
Filgotinib 100 mg (Main Study)
-18.0
± 11.00
Adalimumab 40 mg (Main Study)
-25.2
± 16.60
Placebo (Main Study)
-9.3
± 9.81
Change From Baseline at Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-28.1
± 13.42
Filgotinib 100 mg (Main Study)
-17.4
± 12.16
Adalimumab 40 mg (Main Study)
-25.1
± 14.55
Placebo (Main Study)
-11.3
± 12.18
Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at BaselineSecondary· Baseline, 2, 4, 8, 12, and 16 weeks
The PhGAP is used to determine the participant's psoriasis lesions overall at a given time point. The participant's psoriasis disease activity is assessed by a physician according to the grades of induration, erythema, and scaling on a scale of 0 to 5. The sum of the three grades is used to obtain the total average score. PhGAP is based on the total average score on a scale of 0-5 where, 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, and 5 = severe. A negative change from baseline indicates improvement.
Baseline
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
3
± 1.2
Filgotinib 100 mg (Main Study)
2
± 0.8
Adalimumab 40 mg (Main Study)
2
± 0.5
Placebo (Main Study)
2
± 0.5
Change From Baseline at Week 2
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 0.5
Filgotinib 100 mg (Main Study)
0
± 0.0
Adalimumab 40 mg (Main Study)
0
± 0.5
Placebo (Main Study)
0
± 0.0
Change From Baseline at Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 1.0
Filgotinib 100 mg (Main Study)
0
± 0.5
Adalimumab 40 mg (Main Study)
-1
± 1.0
Placebo (Main Study)
0
± 0.5
Change From Baseline at Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 1.0
Filgotinib 100 mg (Main Study)
-1
± 0.7
Adalimumab 40 mg (Main Study)
-1
± 0.8
Placebo (Main Study)
-1
± 1.0
Change From Baseline at Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 1.3
Filgotinib 100 mg (Main Study)
-1
± 1.1
Adalimumab 40 mg (Main Study)
-2
± 0.6
Placebo (Main Study)
0
± 1.3
Change From Baseline at Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 0.7
Filgotinib 100 mg (Main Study)
-1
± 0.8
Adalimumab 40 mg (Main Study)
-2
± 0.6
Placebo (Main Study)
-1
± 1.4
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at BaselineSecondary· Baseline, 4, 8, 12, and 16 weeks
mNAPSI is used to assess each nail abnormality for each of the participant's nails. Three features or groups of features (pitting, onycholysis together with oil-drop dyschromia, and crumbling) of each fingernail are graded on a scale from 0 (no onycholysis together with oil-drop dyschromia, no pitting, no crumbling) to 3 (\>30 onycholysis together with oil-drop dyschromia, \>50 pitting, \>50% crumbling). Four features (leukonychia, splinter, hemorrhages, hyperkeratosis, and red spots in the lunula) are graded with the score of 1 = present or 0 = absent for each fingernail. Each finger has a sc
Baseline
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
19
± 15.1
Filgotinib 100 mg (Main Study)
15
± 12.9
Adalimumab 40 mg (Main Study)
24
± 32.3
Placebo (Main Study)
14
± 12.9
Change From Baseline at Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-3
± 3.5
Filgotinib 100 mg (Main Study)
1
± 4.5
Adalimumab 40 mg (Main Study)
-3
± 10.0
Placebo (Main Study)
0
± 8.2
Change From Baseline at Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-3
± 5.1
Filgotinib 100 mg (Main Study)
-1
± 5.9
Adalimumab 40 mg (Main Study)
-6
± 19.4
Placebo (Main Study)
-2
± 5.0
Change From Baseline at Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-4
± 6.0
Filgotinib 100 mg (Main Study)
0
± 5.4
Adalimumab 40 mg (Main Study)
-9
± 23.2
Placebo (Main Study)
-3
± 10.6
Change From Baseline at Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
0
± 10.8
Filgotinib 100 mg (Main Study)
-3
± 9.6
Adalimumab 40 mg (Main Study)
-14
± 23.7
Placebo (Main Study)
-2
± 9.2
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at BaselineSecondary· Baseline, 4, 8, 12, and 16 weeks
Enthesitis is assessed using LEI. The enthesitis examination by LEI evaluates the presence or absence of pain by applying local pressure on 6 anatomical sites: medial femoral condyle (left and right), lateral epicondyle (left and right), and the achilles tendon insertion (left and right). Enthesitis at each site is scored as 0 (enthesitis absent) and 1 (enthesitis present). LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. A negative change from baseline indicates improve
Baseline
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
2
± 1.6
Filgotinib 100 mg (Main Study)
2
± 1.4
Adalimumab 40 mg (Main Study)
2
± 1.4
Placebo (Main Study)
2
± 1.7
Change From Baseline at Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 0.8
Filgotinib 100 mg (Main Study)
0
± 0.7
Adalimumab 40 mg (Main Study)
-1
± 1.1
Placebo (Main Study)
0
± 1.5
Change From Baseline at Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 0.8
Filgotinib 100 mg (Main Study)
-1
± 1.2
Adalimumab 40 mg (Main Study)
-2
± 1.5
Placebo (Main Study)
0
± 1.3
Change From Baseline at Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 1.4
Filgotinib 100 mg (Main Study)
-1
± 1.6
Adalimumab 40 mg (Main Study)
-2
± 1.8
Placebo (Main Study)
0
± 1.2
Change From Baseline at Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1
± 1.2
Filgotinib 100 mg (Main Study)
-1
± 1.5
Adalimumab 40 mg (Main Study)
-2
± 1.6
Placebo (Main Study)
0
± 1.5
Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16Secondary· Baseline, 4, and 16 weeks
The PsAID questionnaire assesses the impact of PsA on people's lives. The PsAID is calculated based on 12 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. Total score is calculated as the sum of the individual scores, (some of which were multiplied by a weighting factor) divided by 20 for a total possible score of 0 to 10, where higher score indicates worse impact of disease. A negative change from baseline indicates improvement.
Baseline
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
4.82
± 1.857
Filgotinib 100 mg (Main Study)
4.46
± 2.115
Adalimumab 40 mg (Main Study)
5.28
± 1.765
Placebo (Main Study)
4.44
± 2.071
Change From Baseline at Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-1.71
± 1.282
Filgotinib 100 mg (Main Study)
-1.39
± 1.214
Adalimumab 40 mg (Main Study)
-1.73
± 1.645
Placebo (Main Study)
-0.10
± 1.520
Change From Baseline at Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
-2.06
± 1.314
Filgotinib 100 mg (Main Study)
-2.04
± 1.740
Adalimumab 40 mg (Main Study)
-2.56
± 2.062
Placebo (Main Study)
-0.52
± 2.176
Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16Secondary· Weeks 4, and 16
PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA \[using VAS on a scale of 0=very well to 100=very poor\]; PhGADA \[using VAS on a scale of 0=no disease activity to 100=maximum disease activity\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\]; TJC68; SJC66; leeds enthesitis index(LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates h
Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
21.1
0.1 – 42.0
Filgotinib 100 mg (Main Study)
11.1
0.0 – 28.4
Adalimumab 40 mg (Main Study)
0
0.0 – 6.3
Placebo (Main Study)
5.0
0.0 – 17.1
Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
38.9
13.6 – 64.2
Filgotinib 100 mg (Main Study)
42.1
17.3 – 66.9
Adalimumab 40 mg (Main Study)
50.0
9.1 – 90.9
Placebo (Main Study)
15.0
0.0 – 33.1
Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16Secondary· Weeks 4, and 16
PASDAS is a composite disease activity measure for psoriatic arthritis. It includes components of PGADA \[using VAS on a scale of 0=very well to 100=very poor\]; PhGADA \[using VAS on a scale of 0=no disease activity to 100=maximum disease activity\]; 36-item short form survey (SF-36) \[a questionnaire which measures quality of life across eight domains to determine a physical component summary (PCS) with a score range of 0-100, higher scores indicates better health status\];TJC68;SJC66; leeds enthesitis index(LEI) \[assessed at 6 sites with a score range of 0 to 6, higher scores indicates hig
Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
0
0.0 – 2.6
Filgotinib 100 mg (Main Study)
0
0.0 – 2.8
Adalimumab 40 mg (Main Study)
0
0.0 – 6.3
Placebo (Main Study)
0
0.0 – 2.5
Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
16.7
0.0 – 36.7
Filgotinib 100 mg (Main Study)
10.5
0.0 – 27.0
Adalimumab 40 mg (Main Study)
12.5
0.0 – 41.7
Placebo (Main Study)
5.0
0.0 – 17.1
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16Secondary· Weeks 2, 4, 8, 12, and 16
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGADA using a VAS on a scale of 0 (very well) to 100 (very poor); PHGADA using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity); HAQ-DI inclusive of activities scored on a scale of 0 (no disability) to 3 (completely disabled); HAQ-DI pain assessment using VAS on a scale of 0 (no pain) to 100 (serious pain); and hsCRP. Participants with missing outcomes were set as non-responders.
Week 2
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
26.3
3.9 – 48.7
Filgotinib 100 mg (Main Study)
5.6
0.0 – 18.9
Adalimumab 40 mg (Main Study)
11.1
0.0 – 37.2
Placebo (Main Study)
10.5
0.0 – 27.0
Week 4
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
52.6
27.5 – 77.7
Filgotinib 100 mg (Main Study)
27.8
4.3 – 51.2
Adalimumab 40 mg (Main Study)
33.3
0.0 – 69.7
Placebo (Main Study)
10.0
0.0 – 25.6
Week 8
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
73.7
51.3 – 96.1
Filgotinib 100 mg (Main Study)
36.8
12.5 – 61.2
Adalimumab 40 mg (Main Study)
55.6
17.5 – 93.6
Placebo (Main Study)
31.6
8.0 – 55.1
Week 12
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
77.8
55.8 – 99.8
Filgotinib 100 mg (Main Study)
63.2
38.8 – 87.5
Adalimumab 40 mg (Main Study)
75.0
38.7 – 100.0
Placebo (Main Study)
42.1
17.3 – 66.9
Week 16
Group
Value
95% CI
Filgotinib 200 mg (Main Study)
88.9
71.6 – 100.0
Filgotinib 100 mg (Main Study)
52.6
27.5 – 77.7
Adalimumab 40 mg (Main Study)
77.8
45.1 – 100.0
Placebo (Main Study)
45.0
20.7 – 69.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: First dose date up to 50 weeks plus 30 days; All-Cause Mortality: Randomization up to 50 weeks plus 30 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Filgotinib 200 mg (Main Study)
Serious: 0/19 (0%)
Deaths: 0/19
Filgotinib 100 mg (Main Study)
Serious: 1/19 (5%)
Deaths: 0/19
Adalimumab 40 mg (Main Study)
Serious: 0/9 (0%)
Deaths: 0/9
Placebo (Main Study)
Serious: 0/20 (0%)
Deaths: 0/20
Filgotinib 200 mg From Filgotinib 200 mg (LTE)
Serious: 0/4 (0%)
Deaths: 0/4
Filgotinib 100 mg From Filgotinib 100 mg (LTE)
Serious: 0/3 (0%)
Deaths: 0/3
Filgotinib 200 mg From Adalimumab 40 mg (LTE)
Serious: 0/1 (0%)
Deaths: 0/1
Filgotinib 100 mg From Adalimumab 40 mg (LTE)
Serious: 0/1 (0%)
Deaths: 0/1
Filgotinib 200 mg From Placebo (LTE)
Serious: 1/2 (50%)
Deaths: 0/2
Filgotinib 100 mg From Placebo (LTE)
Serious: 0/2 (0%)
Deaths: 0/2
Serious adverse events (2 terms)
Reaction
System
Filgotinib 200 mg (Main St…
Filgotinib 100 mg (Main St…
Adalimumab 40 mg (Main Stu…
Placebo (Main Study)
Filgotinib 200 mg From Fil…
Filgotinib 100 mg From Fil…
Filgotinib 200 mg From Ada…
Filgotinib 100 mg From Ada…
Filgotinib 200 mg From Pla…
Filgotinib 100 mg From Pla…
Helicobacter infection
Infections and infestations
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Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06527534 — Filgotinib Effect on Proteomic Profile and Micro-RNA Expression in Patients With Active Rheumatoid Arthritis (RA)
· Phase 4
· recruiting
NCT06043739 — Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
· Phase 1
· completed
NCT05479058 — A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
· Phase 3
· terminated
NCT04985435 — Better After CHoosing. Randomly Allocated or Patient Preference Based Treatment With Filgotinib or TNFi in RA (BACH)
· Phase 4
· recruiting
NCT04608344 — Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filg
· Phase 1
· completed
Other recruiting trials for Psoriatic Arthritis
Currently open trials in the same condition.
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· Phase 3
· recruiting
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· Phase 2, PHASE3
· recruiting
NCT07290036 — A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adu
· Phase 1
· recruiting
NCT07180537 — Creating Health Course Study for People With Rheumatological Conditions
· NA
· recruiting
NCT06888193 — A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx®
· Phase 1
· recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 16 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04115748.