NCT03117270

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
6 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

March 30, 2017

Last Update Submit

August 10, 2018

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (16)

  • Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo

    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

    week 12

  • Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo

    week 12

  • Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo

    week 12

  • Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo

    week 12

  • +11 more secondary outcomes

Study Arms (2)

oral filgotinib tablets

EXPERIMENTAL
Drug: filgotinib

placebo tablets

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

filgotinibDRUG

one filgotinib oral tablet q.d.

oral filgotinib tablets
Placebo Oral TabletDRUG

one placebo oral tablet q.d.

placebo tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

ULB Hopital Erasme, Service de Rheumatology

Brussels, Belgium

Location

Eurohospital

Plovdiv, Bulgaria

Location

UMHAT Kaspela EOOD

Plovdiv, Bulgaria

Location

Medical Center "Teodora", EOOD

Rousse, Bulgaria

Location

Akademik Ivan Geshov, UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

Location

Clinic of Rheumatology, UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

Location

UMHAT "SofiaMed", OOD, Block 1

Sofia, Bulgaria

Location

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, Bulgaria

Location

Revmatologicka ambulance

Ostrava, Czechia

Location

CCBR Czech, a.s

Pardubice, Czechia

Location

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Location

OÜ Innomedica

Tallinn, Estonia

Location

Centrum Medyczne SILESIANA Sp z oo

Bytom, Poland

Location

Twoja Przychodnia-Centrum Medyczne Nowa Sol

Nowa Sól, Poland

Location

Ai Centrum Medyczne sp. z o.o. sp.k.

Poznan, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna

Torun, Poland

Location

Centrum Medyczne AMED, Warszawa Targowek

Warsaw, Poland

Location

Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia

Santiago de Compostela, Spain

Location

Hospital Infanta Luisa, Servicio de Reumatologia

Seville, Spain

Location

Hospital Universitario Virgen Macarena, Dept. of Rheumatology

Seville, Spain

Location

CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics

Kharkiv, Ukraine

Location

CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy

Kiev, Ukraine

Location

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh

Kiev, Ukraine

Location

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

Location

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy

Poltava, Ukraine

Location

CI of TRC

Ternopil, Ukraine

Location

A.Novak Transcarpathian Regional Clinical Hospital, Dept of Rheumatology

Uzhhorod, Ukraine

Location

M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1

Vinnytsia, Ukraine

Location

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsia, Ukraine

Location

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Vinnytsia, Ukraine

Location

Related Publications (3)

  • 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.

    PMID: 34647992DERIVED

  • 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.

    PMID: 34352069DERIVED

  • 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.

    PMID: 30360970DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Pille Harrison, MD, DPhil, MRCP (UK)

    Galapagos NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 17, 2017

Study Start

March 7, 2017

Primary Completion

July 2, 2018

Study Completion

July 2, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

CZ(3)ES(1)BU(7)PL(5)UA(10)BE(1)