Back to resultsA Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis (TORTUGA)
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
filgotinib
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility Criteria
Key Inclusion Criteria:
- Male or female subjects who are ≥18 years of age on the day of signing informed consent.
- Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria
- Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale [NRS] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
- Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors.
- If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline.
- If using non-drug therapies (including physical therapies), these should be kept stable during screening.
- Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.
Key Exclusion Criteria:
- Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
- Prior use of more than one TNF inhibitor, at any time.
- Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline;
- Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
- Use of more than 1 NSAID or COX-2 inhibitor.
- Contraindication to MRI.
- History of known or suspected complete ankylosis of the spine.
- Presence of very poor functional status or unable to perform self-care.
- Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
- Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
Sites / Locations
- ULB Hopital Erasme, Service de Rheumatology
- Eurohospital
- UMHAT Kaspela EOOD
- Medical Center "Teodora", EOOD
- Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD
- Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD
- UMHAT "SofiaMed", OOD, Block 1
- Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
- Revmatologicka ambulance
- CCBR Czech, a.s
- MEDICAL PLUS s.r.o.
- OÜ Innomedica
- Centrum Medyczne SILESIANA Sp z oo
- Twoja Przychodnia-Centrum Medyczne Nowa Sol
- Ai Centrum Medyczne sp. z o.o. sp.k.
- Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
- Centrum Medyczne AMED, Warszawa Targowek
- Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia
- Hospital Infanta Luisa, Servicio de Reumatologia
- Hospital Universitario Virgen Macarena, Dept. of Rheumatology
- CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
- CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
- SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
- CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
- M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
- CI of TRC
- A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology
- M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
- SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
- MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oral filgotinib tablets
placebo tablets
Arm Description
Outcomes
Primary Outcome Measures
Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo
To evaluate the effect of filgotinib on the AS disease activity score
Secondary Outcome Measures
Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo
To evaluation the effect of filgotinib on the ASAS score in AS patients
Assessment by a trained joint assessor of 44 joints for tenderness (counting the number or tender joints - TJC) and swelling (counting the number of swollen joints - SJC) in filgotinib treated subjects as compared to placebo
To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient
Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on BAS disease activity index in AS patients
Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on BAS functional index in AS patients
Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on BAS metrology index in AS patients
Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo
To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients
Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients
Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on FACIT fatigue scale in AS patients
Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on SF-36 health survey in AS patients
Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on ASQoL in AS patients
Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events
To assess safety and tolerability of filgotinib in AS patients
Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations
To assess safety and tolerability of filgotinib in AS patients
Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
To assess safety and tolerability of filgotinib in AS patients
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
To assess safety and tolerability of filgotinib in AS patients
Difference between the number of filgotinib treated subjects and placebo with abnormal ECG
To assess safety and tolerability of filgotinib in AS patients
Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment
To assess safety and tolerability of filgotinib in AS patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03117270
Brief Title
A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis
Acronym
TORTUGA
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
July 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral filgotinib tablets
Arm Type
Experimental
Arm Title
placebo tablets
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
filgotinib
Intervention Description
one filgotinib oral tablet q.d.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
one placebo oral tablet q.d.
Primary Outcome Measure Information:
Title
Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo
Description
To evaluate the effect of filgotinib on the AS disease activity score
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo
Description
To evaluation the effect of filgotinib on the ASAS score in AS patients
Time Frame
week 12
Title
Assessment by a trained joint assessor of 44 joints for tenderness (counting the number or tender joints - TJC) and swelling (counting the number of swollen joints - SJC) in filgotinib treated subjects as compared to placebo
Description
To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient
Time Frame
week 12
Title
Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinib on BAS disease activity index in AS patients
Time Frame
week 12
Title
Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinib on BAS functional index in AS patients
Time Frame
week 12
Title
Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinib on BAS metrology index in AS patients
Time Frame
week 12
Title
Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients
Time Frame
week 12
Title
Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients
Time Frame
week 12
Title
Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinib on FACIT fatigue scale in AS patients
Time Frame
week 12
Title
Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinib on SF-36 health survey in AS patients
Time Frame
week 12
Title
Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo
Description
To assess the effect of filgotinib on ASQoL in AS patients
Time Frame
week 12
Title
Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events
Description
To assess safety and tolerability of filgotinib in AS patients
Time Frame
from baseline until the final follow up visit (week 16)
Title
Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations
Description
To assess safety and tolerability of filgotinib in AS patients
Time Frame
from baseline until the final follow up visit (week 16)
Title
Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
Description
To assess safety and tolerability of filgotinib in AS patients
Time Frame
from baseline until the final follow up visit (week 16)
Title
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
Description
To assess safety and tolerability of filgotinib in AS patients
Time Frame
from baseline until the final follow up visit (week 16)
Title
Difference between the number of filgotinib treated subjects and placebo with abnormal ECG
Description
To assess safety and tolerability of filgotinib in AS patients
Time Frame
At baseline, end of study visit (week 12) and final follow up visit (week 16)
Title
Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment
Description
To assess safety and tolerability of filgotinib in AS patients
Time Frame
At baseline and end of study visit (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Male or female subjects who are ≥18 years of age on the day of signing informed consent.
Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria
Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale [NRS] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline.
Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors.
If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline.
If using non-drug therapies (including physical therapies), these should be kept stable during screening.
Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol.
Key Exclusion Criteria:
Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
Prior use of more than one TNF inhibitor, at any time.
Use of oral steroids at a dose >10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline;
Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening;
Use of more than 1 NSAID or COX-2 inhibitor.
Contraindication to MRI.
History of known or suspected complete ankylosis of the spine.
Presence of very poor functional status or unable to perform self-care.
Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening.
Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pille Harrison, MD, DPhil, MRCP (UK)
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
ULB Hopital Erasme, Service de Rheumatology
City
Brussels
Country
Belgium
Facility Name
Eurohospital
City
Plovdiv
Country
Bulgaria
Facility Name
UMHAT Kaspela EOOD
City
Plovdiv
Country
Bulgaria
Facility Name
Medical Center "Teodora", EOOD
City
Ruse
Country
Bulgaria
Facility Name
Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
Country
Bulgaria
Facility Name
Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "SofiaMed", OOD, Block 1
City
Sofia
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
Country
Bulgaria
Facility Name
Revmatologicka ambulance
City
Ostrava
Country
Czechia
Facility Name
CCBR Czech, a.s
City
Pardubice
Country
Czechia
Facility Name
MEDICAL PLUS s.r.o.
City
Uherské Hradiště
Country
Czechia
Facility Name
OÜ Innomedica
City
Tallinn
Country
Estonia
Facility Name
Centrum Medyczne SILESIANA Sp z oo
City
Bytom
Country
Poland
Facility Name
Twoja Przychodnia-Centrum Medyczne Nowa Sol
City
Nowa Sól
Country
Poland
Facility Name
Ai Centrum Medyczne sp. z o.o. sp.k.
City
Poznań
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
City
Toruń
Country
Poland
Facility Name
Centrum Medyczne AMED, Warszawa Targowek
City
Warsaw
Country
Poland
Facility Name
Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Infanta Luisa, Servicio de Reumatologia
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena, Dept. of Rheumatology
City
Sevilla
Country
Spain
Facility Name
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
City
Kharkiv
Country
Ukraine
Facility Name
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
City
Kiev
Country
Ukraine
Facility Name
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
City
Kiev
Country
Ukraine
Facility Name
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
City
L'viv
Country
Ukraine
Facility Name
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
City
Poltava
Country
Ukraine
Facility Name
CI of TRC
City
Ternopil'
Country
Ukraine
Facility Name
A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology
City
Uzhgorod
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
City
Vinnytsia
Country
Ukraine
Facility Name
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
City
Vinnytsia
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
City
Vinnytsya
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34647992
Citation
Maksymowych WP, Ostergaard M, Landewe R, Barchuk W, Liu K, Gilles L, Hendrikx T, Besuyen R, Baraliakos X. Filgotinib decreases both vertebral body and posterolateral spine inflammation in ankylosing spondylitis: results from the TORTUGA trial. Rheumatology (Oxford). 2022 May 30;61(6):2388-2397. doi: 10.1093/rheumatology/keab758.
Results Reference
derived
PubMed Identifier
34352069
Citation
Maksymowych WP, Ostergaard M, Landewe R, Barchuk W, Liu K, Tasset C, Gilles L, Hendrikx T, Besuyen R, Baraliakos X. Impact of filgotinib on sacroiliac joint magnetic resonance imaging structural lesions at 12 weeks in patients with active ankylosing spondylitis (TORTUGA trial). Rheumatology (Oxford). 2022 May 5;61(5):2063-2071. doi: 10.1093/rheumatology/keab543.
Results Reference
derived
PubMed Identifier
30360970
Citation
van der Heijde D, Baraliakos X, Gensler LS, Maksymowych WP, Tseluyko V, Nadashkevich O, Abi-Saab W, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Mozaffarian N, Liu K, Greer JM, Deodhar A, Landewe R. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2378-2387. doi: 10.1016/S0140-6736(18)32463-2. Epub 2018 Oct 22.
Results Reference
derived
Learn more about this trial
A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis
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