Ankylosing SpondylitisPhase 2TORTUGANCT03117270
A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis
A Phase 2 study testing filgotinib in people with Ankylosing Spondylitis, run by Lakefront Biotherapeutics NV at 30 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 30 sitesin 7 countries
- Study dates
- 7 Mar 2017to 2 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
Ukraine10 sites
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
Kharkiv
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
Kiev
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
Kiev
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
Lviv
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
Poltava
CI of TRC
Ternopil
A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology
Uzhhorod
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
Vinnytsia
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Vinnytsia
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
Vinnytsia
Bulgaria7 sites
Eurohospital
Plovdiv
UMHAT Kaspela EOOD
Plovdiv
Medical Center "Teodora", EOOD
Rousse
Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD
Sofia
Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD
Sofia
UMHAT "SofiaMed", OOD, Block 1
Sofia
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora
Poland5 sites
Centrum Medyczne SILESIANA Sp z oo
Bytom
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól
Ai Centrum Medyczne sp. z o.o. sp.k.
Poznan
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Torun
Centrum Medyczne AMED, Warszawa Targowek
Warsaw
Czechia3 sites
Revmatologicka ambulance
Ostrava
CCBR Czech, a.s
Pardubice
MEDICAL PLUS s.r.o.
Uherské Hradiště
Spain3 sites
Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia
Santiago de Compostela
Hospital Infanta Luisa, Servicio de Reumatologia
Seville
Hospital Universitario Virgen Macarena, Dept. of Rheumatology
Seville
About this study
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
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).
- Conditions
- Ankylosing Spondylitis
- Being tested
- filgotinib, Placebo Oral Tablet
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgotinibDrug
one filgotinib oral tablet q.d.
Placebo Oral TabletDrug
one placebo oral tablet q.d.
| Study group | Role | What they receive |
|---|---|---|
| oral filgotinib tablets | Experimental | Not described Receives: Drug: filgotinib |
| placebo tablets | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (16)
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
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
Measured: week 12
Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events
To assess safety and tolerability of filgotinib in AS patients
Measured: from baseline until the final follow up visit (week 16)
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
Measured: from baseline until the final follow up visit (week 16)
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
Measured: from baseline until the final follow up visit (week 16)
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
Measured: from baseline until the final follow up visit (week 16)
Difference between the number of filgotinib treated subjects and placebo with abnormal ECG
To assess safety and tolerability of filgotinib in AS patients
Measured: At baseline, end of study visit (week 12) and final follow up visit (week 16)
Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment
To assess safety and tolerability of filgotinib in AS patients
Measured: At baseline and end of study visit (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start7 Mar 2017
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pille Harrison, MD, DPhil, MRCP (UK), Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117270
- Sponsor's protocol ID
- GLPG0634-CL-223
- Acronym
- TORTUGA
- Status last verified
- Aug 2018
- First submitted
- 30 Mar 2017
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34647992Maksymowych 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.
PubMed 34352069van 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.
PubMed 30360970
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03117270
- Acronym / sponsor ID
- TORTUGA / GLPG0634-CL-223
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral filgotinib tablets | Experimental | Drug: filgotinib |
| placebo tablets | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgotinibone filgotinib oral tablet q.d. | Drug | oral filgotinib tablets |
| Placebo Oral Tabletone placebo oral tablet q.d. | Drug | placebo tablets |
Primary outcome
Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo
Time frame: week 12
To evaluate the effect of filgotinib on the AS disease activity score
16 secondary outcomes
Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo
Time frame: week 12
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
Time frame: week 12
Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo
Time frame: week 12
Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo
Time frame: week 12
Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events
Time frame: from baseline until the final follow up visit (week 16)
Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations
Time frame: from baseline until the final follow up visit (week 16)
Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
Time frame: from baseline until the final follow up visit (week 16)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
Time frame: from baseline until the final follow up visit (week 16)
Difference between the number of filgotinib treated subjects and placebo with abnormal ECG
Time frame: At baseline, end of study visit (week 12) and final follow up visit (week 16)
Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment
Time frame: At baseline and end of study visit (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 34647992Maksymowych 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.
- Derived from this study: PubMed 34352069Maksymowych 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.
- Derived from this study: PubMed 30360970van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pille Harrison, MD, DPhil, MRCP (UK) study director
Lakefront Biotherapeutics NV
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgotinib in people with Ankylosing Spondylitis, run by Lakefront Biotherapeutics NV at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Ukraine, Bulgaria, Poland, Czechia, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117270, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.