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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02065700




Registration number
NCT02065700
Ethics application status
Date submitted
14/02/2014
Date registered
19/02/2014
Date last updated
6/02/2020

Titles & IDs
Public title
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients
Scientific title
A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2012-003655-11
Secondary ID [2] 0 0
GLPG0634-CL-205 (DARWIN3)
Universal Trial Number (UTN)
Trial acronym
DARWIN3
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

Experimental: Filgotinib 200 mg once daily - Filgotinib 200 mg (2 x 100 mg) once daily (morning)

Experimental: Filgotinib 100 mg twice daily - Filgotinib 100 mg twice daily (morning and evening)


Treatment: Drugs: Filgotinib
Tablets administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of Long-Term Dosing of Filgotinib as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Approximately 96 months, from Entry Visit (last visit from the previous core study, GLPG0634-CL-203 or GLPG0634-CL-204) to Final Visit (last dose) plus 2 weeks
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR)20 Response at Every Visit
Timepoint [1] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [2] 0 0
Percentage of Participants Achieving ACR50 Response at Every Visit
Timepoint [2] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [3] 0 0
Percentage of Participants Achieving ACR70 Response at Every Visit
Timepoint [3] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [4] 0 0
Percentage of Participants Achieving ACR-N Response at Every Visit
Timepoint [4] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [5] 0 0
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response at Every Visit
Timepoint [5] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [6] 0 0
Percentage of Participants Achieving ACR/EULAR Remission at Every Visit
Timepoint [6] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [7] 0 0
Percentage of Participants Achieving a Clinical Disease Activity Index (CDAI) Response at Every Visit
Timepoint [7] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [8] 0 0
Percentage of Participants Achieving a Simplified Disease Activity Index (SDAI) Response at Every Visit
Timepoint [8] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [9] 0 0
Percentage of Participants Achieving a Disease Activity Score Based on 28 Joints and C-Reactive Protein (DAS28-CRP) Response at Every Visit
Timepoint [9] 0 0
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Secondary outcome [10] 0 0
Quality of Life: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Every 48 Weeks
Timepoint [10] 0 0
Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose)
Secondary outcome [11] 0 0
Quality of Life: Change from Baseline in the 36-Item Short Form Health Survey (SF-36) Score every 48 Weeks
Timepoint [11] 0 0
Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose)

Eligibility
Key inclusion criteria
Key

- Male or female who are 18 years of age or older on the day of signing informed consent

- Participants who completed one of the qualifying core studies GLPG0634-CL-203 or
GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the
Investigator's judgment

- Females of childbearing potential and sexually active men must agree to use highly
effective method of birth control as specified in the protocol, during the study and
for at least 12 weeks after the last dose of filgotinib

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203
or GLPG0634-CL-204), for any reason

- Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or
GLPG0634-CL-204), according to the Investigator's judgment

- Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than
rheumatoid arthritis, except for secondary Sjogren's syndrome

- Any condition or circumstances which, in the opinion of the Investigator, may make a
participant unlikely or unable to complete the study or comply with study procedures
and requirements

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Repatriation General Hospital - Daw Park
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Daw Park
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Argentina
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Buenos Aires
Country [12] 0 0
Argentina
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Cordoba
Country [13] 0 0
Argentina
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Lanus
Country [14] 0 0
Argentina
State/province [14] 0 0
Rosario
Country [15] 0 0
Argentina
State/province [15] 0 0
San Fernando
Country [16] 0 0
Argentina
State/province [16] 0 0
San Miguel de Tucumán
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussels
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Plovdiv
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Ruse
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Sofia
Country [22] 0 0
Chile
State/province [22] 0 0
Santiago
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Chile
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Temuco
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Colombia
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Santander
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Bogotá
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Colombia
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Cundinamarca
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Colombia
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Medellin
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
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Czechia
State/province [31] 0 0
Kladno
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha-Nusle
Country [33] 0 0
Czechia
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Zlin
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France
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Strasbourg CEDEX
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Germany
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Berlin
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Germany
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Hamburg
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Guatemala
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Guatemala City
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Guatemala
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Guatemala
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Eger
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Hungary
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Veszprem
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Israel
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Haifa
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Latvia
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Adazi
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Latvia
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Baldone
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Latvia
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Daugavpils
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Latvia
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Liepaja
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Latvia
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Riga
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Mexico
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Ciudad de México
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Mexico
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Oaxaca
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Moldova, Republic of
State/province [54] 0 0
Chisinau
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New Zealand
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Hamilton
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New Zealand
State/province [56] 0 0
Timaru
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Poland
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Bialystok
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Poland
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Bytom
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Skierniewice
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Poland
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Starachowice
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Poland
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Torun
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Poland
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Warsaw
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Poland
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Warszawa
Country [66] 0 0
Romania
State/province [66] 0 0
Bucuresti
Country [67] 0 0
Romania
State/province [67] 0 0
Galati
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Moscow
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Nizhniy Novgorod
Country [70] 0 0
Russian Federation
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Orenburg
Country [71] 0 0
Russian Federation
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Ryazan
Country [72] 0 0
Russian Federation
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Saratov
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Russian Federation
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St Petersburg
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Russian Federation
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Vladimir
Country [75] 0 0
Spain
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A Coruña
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Spain
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Sabadell
Country [77] 0 0
Ukraine
State/province [77] 0 0
Kharkiv
Country [78] 0 0
Ukraine
State/province [78] 0 0
Kherson
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kiev
Country [80] 0 0
Ukraine
State/province [80] 0 0
Kyiv
Country [81] 0 0
Ukraine
State/province [81] 0 0
Vinnytsya

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
The primary objective of the study is to evaluate the long-term safety and tolerability of
filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.

Participants will be enrolled in this open-label long-term follow-up study after they have
completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204
(DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and
tolerability) when taking filgotinib. During the course of the study, participants will also
be examined for long-term effects of filgotinib administration on disease activity
(efficacy), subjects' disability, fatigue, and quality of life.
Trial website
https://clinicaltrials.gov/show/NCT02065700
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

Summary results
Other publications