Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02889796




Registration number
NCT02889796
Ethics application status
Date submitted
31/08/2016
Date registered
7/09/2016

Titles & IDs
Public title
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Scientific title
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Secondary ID [1] 0 0
2016-000568-41
Secondary ID [2] 0 0
GS-US-417-0301
Universal Trial Number (UTN)
Trial acronym
FINCH 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo to match adalimumab
Treatment: Drugs - MTX

Experimental: Filgotinib 200 mg - Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

Experimental: Filgotinib 100 mg - Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

Active comparator: Adalimumab - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX

Experimental: Placebo to Filgotinib 200 mg - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

Experimental: Placebo to Filgotinib 100 mg - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

Placebo comparator: Placebo Never Received Filgotinib - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.


Treatment: Drugs: Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily

Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily

Treatment: Drugs: Adalimumab
40 mg administered via subcutaneous injection once every two weeks

Treatment: Drugs: Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks

Treatment: Drugs: MTX
Commercially sourced tablet(s) administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Timepoint [1] 0 0
Baseline; Week 12
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
Timepoint [3] 0 0
Baseline; Week 24
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Timepoint [5] 0 0
Baseline; Week 12
Secondary outcome [6] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
Timepoint [6] 0 0
Baseline; Week 12
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
Timepoint [7] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52
Timepoint [8] 0 0
Weeks 36, and 52
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
Timepoint [9] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52
Timepoint [10] 0 0
Weeks 36, and 52
Secondary outcome [11] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
Timepoint [11] 0 0
Weeks 2, 4, and 24
Secondary outcome [12] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52
Timepoint [12] 0 0
Weeks 36, and 52
Secondary outcome [13] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
Timepoint [13] 0 0
Baseline; Weeks 2, 4, and 24
Secondary outcome [14] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52
Timepoint [14] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [15] 0 0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
Timepoint [15] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [16] 0 0
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52
Timepoint [16] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [17] 0 0
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
Timepoint [17] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [18] 0 0
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52
Timepoint [18] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [19] 0 0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
Timepoint [19] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [20] 0 0
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52
Timepoint [20] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [21] 0 0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
Timepoint [21] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [22] 0 0
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52
Timepoint [22] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [23] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24
Timepoint [23] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [24] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52
Timepoint [24] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [25] 0 0
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24
Timepoint [25] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [26] 0 0
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52
Timepoint [26] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [27] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 2, 4, 12, and 24
Timepoint [27] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [28] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 36, and 52
Timepoint [28] 0 0
Weeks 36, and 52
Secondary outcome [29] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24
Timepoint [29] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [30] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52
Timepoint [30] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [31] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 2, 4, and 24
Timepoint [31] 0 0
Weeks 2, 4, and 24
Secondary outcome [32] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 36, and 52
Timepoint [32] 0 0
Weeks 36, and 52
Secondary outcome [33] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24
Timepoint [33] 0 0
Weeks 2, 4, and 24
Secondary outcome [34] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52
Timepoint [34] 0 0
Weeks 36, and 52
Secondary outcome [35] 0 0
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
Timepoint [35] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [36] 0 0
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52
Timepoint [36] 0 0
Weeks 36, and 52
Secondary outcome [37] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
Timepoint [37] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [38] 0 0
Number of Participants With EULAR Response at Weeks 36, and 52
Timepoint [38] 0 0
Weeks 36, and 52
Secondary outcome [39] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
Timepoint [39] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [40] 0 0
Change From Baseline in CDAI at Weeks 36, and 52
Timepoint [40] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [41] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24
Timepoint [41] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [42] 0 0
Change From Baseline in SDAI at Weeks 36, and 52
Timepoint [42] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [43] 0 0
Change From Baseline in mTSS at Week 52
Timepoint [43] 0 0
Baseline; Week 52
Secondary outcome [44] 0 0
Percentage of Participants With no Radiographic Progression From Baseline at Week 24
Timepoint [44] 0 0
Baseline; Weeks 24
Secondary outcome [45] 0 0
Percentage of Participants With no Radiographic Progression From Baseline at Week 52
Timepoint [45] 0 0
Baseline; Week 52
Secondary outcome [46] 0 0
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24
Timepoint [46] 0 0
Weeks 4, 12, and 24
Secondary outcome [47] 0 0
SF-36 PCS Score at Weeks 36, and 52
Timepoint [47] 0 0
Weeks 36, and 52
Secondary outcome [48] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Timepoint [48] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [49] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52
Timepoint [49] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [50] 0 0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Timepoint [50] 0 0
Weeks 4, 12, and 24
Secondary outcome [51] 0 0
SF-36 MCS Score at Weeks 36, and 52
Timepoint [51] 0 0
Weeks 36, and 52
Secondary outcome [52] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Timepoint [52] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [53] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52
Timepoint [53] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [54] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24
Timepoint [54] 0 0
Weeks 4, 12, and 24
Secondary outcome [55] 0 0
FACIT-Fatigue Score at Weeks 36, and 52
Timepoint [55] 0 0
Weeks 36, and 52
Secondary outcome [56] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Timepoint [56] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [57] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52
Timepoint [57] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [58] 0 0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Timepoint [58] 0 0
Weeks 4, 12, and 24
Secondary outcome [59] 0 0
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52
Timepoint [59] 0 0
Weeks 36, and 52
Secondary outcome [60] 0 0
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Timepoint [60] 0 0
Weeks 4, 12, and 24
Secondary outcome [61] 0 0
EQ-5D Current Health VAS at Weeks 36, and 52
Timepoint [61] 0 0
Weeks 36, and 52
Secondary outcome [62] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Timepoint [62] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [63] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52
Timepoint [63] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [64] 0 0
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Timepoint [64] 0 0
Weeks 4, 12, and 24
Secondary outcome [65] 0 0
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Timepoint [65] 0 0
Weeks 36, and 52
Secondary outcome [66] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Timepoint [66] 0 0
Weeks 4, 12, and 24
Secondary outcome [67] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Timepoint [67] 0 0
Weeks 36, and 52
Secondary outcome [68] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [68] 0 0
Weeks 4, 12, and 24
Secondary outcome [69] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Timepoint [69] 0 0
Weeks 36, and 52
Secondary outcome [70] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [70] 0 0
Weeks 4, 12, and 24
Secondary outcome [71] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Timepoint [71] 0 0
Weeks 36, and 52
Secondary outcome [72] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Timepoint [72] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [73] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Timepoint [73] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [74] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Timepoint [74] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [75] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Timepoint [75] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [76] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [76] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [77] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Timepoint [77] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [78] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [78] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [79] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Timepoint [79] 0 0
Baseline; Weeks 36, and 52

Eligibility
Key inclusion criteria
Key

* Have a diagnosis of rheumatoid arthritis (RA) [2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria] , and are ACR functional class I-III.
* Have = 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and = 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
* Ongoing treatment with a stable dose of MTX

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2019
Sample size
Target
Accrual to date
Final
1759
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Caba
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Argentina
State/province [22] 0 0
Quilmes
Country [23] 0 0
Argentina
State/province [23] 0 0
San Fernando
Country [24] 0 0
Argentina
State/province [24] 0 0
San Juan
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel De Tucumán
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels
Country [27] 0 0
Belgium
State/province [27] 0 0
Genk
Country [28] 0 0
Belgium
State/province [28] 0 0
Merksem
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Dobrich
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Haskovo
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Varna
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Vidin
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czechia
State/province [36] 0 0
Praha
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava-Poruba
Country [39] 0 0
Czechia
State/province [39] 0 0
Ostrava
Country [40] 0 0
Czechia
State/province [40] 0 0
Prague 10
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 4
Country [42] 0 0
Czechia
State/province [42] 0 0
Uherske Hradiste
Country [43] 0 0
Germany
State/province [43] 0 0
Frankfurt a Main
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
Ratingen
Country [46] 0 0
Hong Kong
State/province [46] 0 0
Hong Kong
Country [47] 0 0
Hungary
State/province [47] 0 0
Bacs-kiskun
Country [48] 0 0
Hungary
State/province [48] 0 0
Csongrad
Country [49] 0 0
Hungary
State/province [49] 0 0
Fejer
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Eger
Country [52] 0 0
India
State/province [52] 0 0
Ahmedabad
Country [53] 0 0
India
State/province [53] 0 0
Bangalore
Country [54] 0 0
India
State/province [54] 0 0
Chennai
Country [55] 0 0
India
State/province [55] 0 0
Delhi
Country [56] 0 0
India
State/province [56] 0 0
Gurgaon
Country [57] 0 0
India
State/province [57] 0 0
Hyderabad
Country [58] 0 0
India
State/province [58] 0 0
Jaipur
Country [59] 0 0
India
State/province [59] 0 0
Kolkata
Country [60] 0 0
India
State/province [60] 0 0
Lucknow
Country [61] 0 0
India
State/province [61] 0 0
Mangalore
Country [62] 0 0
India
State/province [62] 0 0
Nagpur
Country [63] 0 0
India
State/province [63] 0 0
New Delhi
Country [64] 0 0
India
State/province [64] 0 0
Pune
Country [65] 0 0
India
State/province [65] 0 0
Secunderabad
Country [66] 0 0
India
State/province [66] 0 0
Srikakulam
Country [67] 0 0
India
State/province [67] 0 0
Surat
Country [68] 0 0
India
State/province [68] 0 0
Vadodara
Country [69] 0 0
India
State/province [69] 0 0
Visakhapatnam
Country [70] 0 0
Ireland
State/province [70] 0 0
Dublin 4
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Aviv
Country [73] 0 0
Israel
State/province [73] 0 0
Tel-Hashomer
Country [74] 0 0
Italy
State/province [74] 0 0
Bologna
Country [75] 0 0
Italy
State/province [75] 0 0
Catania
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Japan
State/province [77] 0 0
Chiba-shi
Country [78] 0 0
Japan
State/province [78] 0 0
Fukuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Hiroshima
Country [80] 0 0
Japan
State/province [80] 0 0
Iizuka-shi
Country [81] 0 0
Japan
State/province [81] 0 0
Iruma-gun
Country [82] 0 0
Japan
State/province [82] 0 0
Izumo
Country [83] 0 0
Japan
State/province [83] 0 0
Kagoshima-shi
Country [84] 0 0
Japan
State/province [84] 0 0
Kato
Country [85] 0 0
Japan
State/province [85] 0 0
Kitakyushu-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Kobe
Country [87] 0 0
Japan
State/province [87] 0 0
Kumamoto
Country [88] 0 0
Japan
State/province [88] 0 0
Kurume-shi
Country [89] 0 0
Japan
State/province [89] 0 0
Kyoto-shi
Country [90] 0 0
Japan
State/province [90] 0 0
Kyoto
Country [91] 0 0
Japan
State/province [91] 0 0
Miyazaki
Country [92] 0 0
Japan
State/province [92] 0 0
Morioka
Country [93] 0 0
Japan
State/province [93] 0 0
Nagaoka
Country [94] 0 0
Japan
State/province [94] 0 0
Nagasaki-shi
Country [95] 0 0
Japan
State/province [95] 0 0
Nagasaki
Country [96] 0 0
Japan
State/province [96] 0 0
Nagoya
Country [97] 0 0
Japan
State/province [97] 0 0
Narashino
Country [98] 0 0
Japan
State/province [98] 0 0
Nishinomiya
Country [99] 0 0
Japan
State/province [99] 0 0
Sanuki-shi
Country [100] 0 0
Japan
State/province [100] 0 0
Sapporo
Country [101] 0 0
Japan
State/province [101] 0 0
Sasebo-shi
Country [102] 0 0
Japan
State/province [102] 0 0
Sayama-shi
Country [103] 0 0
Japan
State/province [103] 0 0
Shibata-City
Country [104] 0 0
Japan
State/province [104] 0 0
Shinjuku-Ku
Country [105] 0 0
Japan
State/province [105] 0 0
Shizuoka
Country [106] 0 0
Japan
State/province [106] 0 0
Suita-shi
Country [107] 0 0
Japan
State/province [107] 0 0
Takaoka
Country [108] 0 0
Japan
State/province [108] 0 0
Takasaki-shi
Country [109] 0 0
Japan
State/province [109] 0 0
Tokorozawa
Country [110] 0 0
Japan
State/province [110] 0 0
Tokyo
Country [111] 0 0
Japan
State/province [111] 0 0
Tsukuba-shi
Country [112] 0 0
Japan
State/province [112] 0 0
Wakayama
Country [113] 0 0
Japan
State/province [113] 0 0
Yokohama-shi
Country [114] 0 0
Japan
State/province [114] 0 0
Oita
Country [115] 0 0
Korea, Republic of
State/province [115] 0 0
Anyang-si
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Busan
Country [117] 0 0
Korea, Republic of
State/province [117] 0 0
Daegu
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Daejeon
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Gwangju
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Incheon
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Jeonju
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Seoul
Country [123] 0 0
Mexico
State/province [123] 0 0
Yucatan
Country [124] 0 0
Mexico
State/province [124] 0 0
Chihuahua
Country [125] 0 0
Mexico
State/province [125] 0 0
Ciudad de Mexico
Country [126] 0 0
Mexico
State/province [126] 0 0
Distrito Federal
Country [127] 0 0
Mexico
State/province [127] 0 0
Monterrey
Country [128] 0 0
Mexico
State/province [128] 0 0
Morelia
Country [129] 0 0
Mexico
State/province [129] 0 0
Mérida
Country [130] 0 0
Netherlands
State/province [130] 0 0
Leiden
Country [131] 0 0
New Zealand
State/province [131] 0 0
Auckland
Country [132] 0 0
New Zealand
State/province [132] 0 0
Hamilton
Country [133] 0 0
New Zealand
State/province [133] 0 0
Newtown
Country [134] 0 0
New Zealand
State/province [134] 0 0
Timaru
Country [135] 0 0
Poland
State/province [135] 0 0
Dolnoslaskie
Country [136] 0 0
Poland
State/province [136] 0 0
Bialystok
Country [137] 0 0
Poland
State/province [137] 0 0
Bydgoszcz
Country [138] 0 0
Poland
State/province [138] 0 0
Bytom
Country [139] 0 0
Poland
State/province [139] 0 0
Elblag
Country [140] 0 0
Poland
State/province [140] 0 0
Gdynia
Country [141] 0 0
Poland
State/province [141] 0 0
Kartuzy
Country [142] 0 0
Poland
State/province [142] 0 0
Katowice
Country [143] 0 0
Poland
State/province [143] 0 0
Krakow
Country [144] 0 0
Poland
State/province [144] 0 0
Nowa Sól
Country [145] 0 0
Poland
State/province [145] 0 0
Poznan
Country [146] 0 0
Poland
State/province [146] 0 0
Tomaszów Lubelski
Country [147] 0 0
Poland
State/province [147] 0 0
Torun
Country [148] 0 0
Poland
State/province [148] 0 0
Warsaw
Country [149] 0 0
Poland
State/province [149] 0 0
Warszawa
Country [150] 0 0
Romania
State/province [150] 0 0
Bihor
Country [151] 0 0
Romania
State/province [151] 0 0
Bucuresti
Country [152] 0 0
Romania
State/province [152] 0 0
Bacau
Country [153] 0 0
Romania
State/province [153] 0 0
Târgu-Mures
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Barnaul
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Chelyabinsk
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Kazan
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Kemerovo
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Moscow
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Nizhniy Novgorod
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Saint Petersburg
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Saratov
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Vladimir
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Yaroslavl
Country [164] 0 0
Serbia
State/province [164] 0 0
Belgrade
Country [165] 0 0
Serbia
State/province [165] 0 0
Niška Banja
Country [166] 0 0
Slovakia
State/province [166] 0 0
Bratislava
Country [167] 0 0
Slovakia
State/province [167] 0 0
Prievidza
Country [168] 0 0
Slovakia
State/province [168] 0 0
Rimavska Sobota
Country [169] 0 0
Slovakia
State/province [169] 0 0
Topol'cany
Country [170] 0 0
South Africa
State/province [170] 0 0
Cape Town
Country [171] 0 0
South Africa
State/province [171] 0 0
Durban
Country [172] 0 0
South Africa
State/province [172] 0 0
Johannesburg
Country [173] 0 0
Spain
State/province [173] 0 0
La Coruna
Country [174] 0 0
Spain
State/province [174] 0 0
Málaga
Country [175] 0 0
Spain
State/province [175] 0 0
Sabadell
Country [176] 0 0
Spain
State/province [176] 0 0
Santiago de Compostela
Country [177] 0 0
Spain
State/province [177] 0 0
Valencia
Country [178] 0 0
Taiwan
State/province [178] 0 0
Changhua
Country [179] 0 0
Taiwan
State/province [179] 0 0
Kaohsiung
Country [180] 0 0
Taiwan
State/province [180] 0 0
Keelung
Country [181] 0 0
Taiwan
State/province [181] 0 0
Taichung
Country [182] 0 0
Taiwan
State/province [182] 0 0
Tainan
Country [183] 0 0
Taiwan
State/province [183] 0 0
Taipei
Country [184] 0 0
Taiwan
State/province [184] 0 0
Taoyuan
Country [185] 0 0
Thailand
State/province [185] 0 0
Bangkok
Country [186] 0 0
Thailand
State/province [186] 0 0
Chiangmai
Country [187] 0 0
Thailand
State/province [187] 0 0
Songkla
Country [188] 0 0
Ukraine
State/province [188] 0 0
Dnipro
Country [189] 0 0
Ukraine
State/province [189] 0 0
Kharkiv
Country [190] 0 0
Ukraine
State/province [190] 0 0
Kherson
Country [191] 0 0
Ukraine
State/province [191] 0 0
Kiev
Country [192] 0 0
Ukraine
State/province [192] 0 0
Kyiv
Country [193] 0 0
Ukraine
State/province [193] 0 0
L'viv
Country [194] 0 0
Ukraine
State/province [194] 0 0
Luts'k
Country [195] 0 0
Ukraine
State/province [195] 0 0
Lviv
Country [196] 0 0
Ukraine
State/province [196] 0 0
Odessa
Country [197] 0 0
Ukraine
State/province [197] 0 0
Vinnytsia
Country [198] 0 0
Ukraine
State/province [198] 0 0
Vinnytsya
Country [199] 0 0
Ukraine
State/province [199] 0 0
Zaporizhzhya
Country [200] 0 0
United Kingdom
State/province [200] 0 0
England
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Doncaster
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Edinburgh
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Newcastle Upon Tyne
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Combe B, Kivitz A, Tanaka Y, van der Heijde D, Mat... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02889796