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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02065700
Ethics application status
Date submitted
14/02/2014
Date registered
19/02/2014

Titles & IDs
Public title
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
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
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 Darwin 1 - Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.

In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.

Experimental: Filgotinib Darwin 2 - Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.

Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.


Treatment: Drugs: Filgotinib
Administered as Oral Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Treatment-Emergent Adverse Events
Timepoint [1] 0 0
From First dose to Week 437
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Timepoint [1] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [2] 0 0
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Timepoint [2] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [3] 0 0
Percentage of Participants Achieving ACR50 Response: NRI
Timepoint [3] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [4] 0 0
Percentage of Participants Achieving ACR50 Response: OC
Timepoint [4] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [5] 0 0
Percentage of Participants Achieving ACR70 Response: NRI
Timepoint [5] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [6] 0 0
Percentage of Participants Achieving ACR70 Response: OC
Timepoint [6] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [7] 0 0
ACR N% Improvement (ACR-N) Response: OC
Timepoint [7] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [8] 0 0
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Timepoint [8] 0 0
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [9] 0 0
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Timepoint [9] 0 0
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [10] 0 0
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Timepoint [10] 0 0
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [11] 0 0
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Timepoint [11] 0 0
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [12] 0 0
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Timepoint [12] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [13] 0 0
Percentage of Participants Achieving ACR/EULAR Remission: OC
Timepoint [13] 0 0
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Secondary outcome [14] 0 0
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Timepoint [14] 0 0
Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Secondary outcome [15] 0 0
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Timepoint [15] 0 0
Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Secondary outcome [16] 0 0
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Timepoint [16] 0 0
Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384

Eligibility
Key inclusion criteria
Key

* 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
Sex
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
Non-randomised 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/01/2023
Sample size
Target
Accrual to date
Final
739
Recruitment in Australia
Recruitment state(s)
Flinders Drive, SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Cordoba
Country [13] 0 0
Argentina
State/province [13] 0 0
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
Country [23] 0 0
Chile
State/province [23] 0 0
Temuco
Country [24] 0 0
Colombia
State/province [24] 0 0
Santander
Country [25] 0 0
Colombia
State/province [25] 0 0
Barranquilla
Country [26] 0 0
Colombia
State/province [26] 0 0
Bogota
Country [27] 0 0
Colombia
State/province [27] 0 0
Bogotá
Country [28] 0 0
Colombia
State/province [28] 0 0
Cundinamarca
Country [29] 0 0
Colombia
State/province [29] 0 0
Medellin
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
Country [31] 0 0
Czechia
State/province [31] 0 0
Kladno
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha-Nusle
Country [33] 0 0
Czechia
State/province [33] 0 0
Zlin
Country [34] 0 0
France
State/province [34] 0 0
Strasbourg CEDEX
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Guatemala
State/province [37] 0 0
Guatemala City
Country [38] 0 0
Guatemala
State/province [38] 0 0
Guatemala
Country [39] 0 0
Hungary
State/province [39] 0 0
Balatonfured
Country [40] 0 0
Hungary
State/province [40] 0 0
Budapest
Country [41] 0 0
Hungary
State/province [41] 0 0
Eger
Country [42] 0 0
Hungary
State/province [42] 0 0
Veszprem
Country [43] 0 0
Israel
State/province [43] 0 0
Haifa
Country [44] 0 0
Latvia
State/province [44] 0 0
Adazi
Country [45] 0 0
Latvia
State/province [45] 0 0
Baldone
Country [46] 0 0
Latvia
State/province [46] 0 0
Daugavpils
Country [47] 0 0
Latvia
State/province [47] 0 0
Liepaja
Country [48] 0 0
Latvia
State/province [48] 0 0
Riga
Country [49] 0 0
Mexico
State/province [49] 0 0
Ciudad de Mexico
Country [50] 0 0
Mexico
State/province [50] 0 0
Guadalajara
Country [51] 0 0
Mexico
State/province [51] 0 0
Mexico
Country [52] 0 0
Mexico
State/province [52] 0 0
Monterrey
Country [53] 0 0
Mexico
State/province [53] 0 0
Oaxaca
Country [54] 0 0
Moldova, Republic of
State/province [54] 0 0
Chisinau
Country [55] 0 0
New Zealand
State/province [55] 0 0
Hamilton
Country [56] 0 0
New Zealand
State/province [56] 0 0
Timaru
Country [57] 0 0
Poland
State/province [57] 0 0
Bialystok
Country [58] 0 0
Poland
State/province [58] 0 0
Bytom
Country [59] 0 0
Poland
State/province [59] 0 0
Katowice
Country [60] 0 0
Poland
State/province [60] 0 0
Krakow
Country [61] 0 0
Poland
State/province [61] 0 0
Skierniewice
Country [62] 0 0
Poland
State/province [62] 0 0
Starachowice
Country [63] 0 0
Poland
State/province [63] 0 0
Torun
Country [64] 0 0
Poland
State/province [64] 0 0
Warsaw
Country [65] 0 0
Poland
State/province [65] 0 0
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
State/province [70] 0 0
Orenburg
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Ryazan
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Saratov
Country [73] 0 0
Russian Federation
State/province [73] 0 0
St Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Vladimir
Country [75] 0 0
Spain
State/province [75] 0 0
A Coruña
Country [76] 0 0
Spain
State/province [76] 0 0
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
Galapagos NV
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
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
Galapagos Study Director
Address 0 0
Galapagos NV
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)?
Yes
What data in particular will be shared?
Qualified external researchers may request IPD for clinical trials that support an approved indication in the EU and the US for which Galapagos is the Marketing Authorisation / New Drug Application Holder, with a marketing authorisation date on or after January 1, 2021 and for which the summary results have been published on ClinicalTrials.gov (CT.gov) and/or the EU Clinical Trials Register (EU CTR). For clinical trials of newly approved compounds or indications the IPD can be requested at earliest 6 months after the EMA and FDA approval. The study last patient last visit (LPLV) must have occurred at least 18 months prior to the request.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT02065700