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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral filgotinib tablets | Experimental |
| |
| placebo tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgotinib | Drug | one filgotinib oral tablet q.d. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pille Harrison, MD, DPhil, MRCP (UK) | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULB Hopital Erasme, Service de Rheumatology | Brussels | Belgium | ||||
| Eurohospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34647992 | Derived | 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. | |
| 34352069 |
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| Placebo Oral Tablet |
| Drug |
one placebo oral tablet q.d. |
|
To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At baseline and end of study visit (week 12) |
| Plovdiv |
| Bulgaria |
| UMHAT Kaspela EOOD | Plovdiv | Bulgaria |
| Medical Center "Teodora", EOOD | Rousse | Bulgaria |
| Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD | Sofia | Bulgaria |
| Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD | Sofia | Bulgaria |
| UMHAT "SofiaMed", OOD, Block 1 | Sofia | Bulgaria |
| Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora | Bulgaria |
| Revmatologicka ambulance | Ostrava | Czechia |
| CCBR Czech, a.s | Pardubice | Czechia |
| MEDICAL PLUS s.r.o. | Uherské Hradiště | Czechia |
| OÜ Innomedica | Tallinn | Estonia |
| Centrum Medyczne SILESIANA Sp z oo | Bytom | Poland |
| Twoja Przychodnia-Centrum Medyczne Nowa Sol | Nowa Sól | Poland |
| Ai Centrum Medyczne sp. z o.o. sp.k. | Poznan | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna | Torun | Poland |
| Centrum Medyczne AMED, Warszawa Targowek | Warsaw | Poland |
| Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia | Santiago de Compostela | Spain |
| Hospital Infanta Luisa, Servicio de Reumatologia | Seville | Spain |
| Hospital Universitario Virgen Macarena, Dept. of Rheumatology | Seville | Spain |
| CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics | Kharkiv | Ukraine |
| CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy | Kiev | Ukraine |
| SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh | Kiev | Ukraine |
| CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology | Lviv | Ukraine |
| M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy | Poltava | Ukraine |
| CI of TRC | Ternopil | Ukraine |
| A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology | Uzhhorod | Ukraine |
| M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1 | Vinnytsia | Ukraine |
| MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology | Vinnytsia | Ukraine |
| SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy | Vinnytsia | Ukraine |
| 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. |
| 30360970 | Derived | 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. |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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