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Trial record 21 of 381 for:    Ankylosing Spondylitis

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis (TORTUGA)

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ClinicalTrials.gov Identifier: NCT03117270
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

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).

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: filgotinib Drug: Placebo Oral Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : July 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oral filgotinib tablets Drug: filgotinib
one filgotinib oral tablet q.d.

Placebo Comparator: placebo tablets Drug: Placebo Oral Tablet
one placebo oral tablet q.d.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To evaluation the effect of filgotinib on the ASAS score in AS patients

  2. 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 ]
    To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient

  3. Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on BAS disease activity index in AS patients

  4. Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on BAS functional index in AS patients

  5. Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on BAS metrology index in AS patients

  6. Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients

  7. Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients

  8. Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on FACIT fatigue scale in AS patients

  9. Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on SF-36 health survey in AS patients

  10. Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo [ Time Frame: week 12 ]
    To assess the effect of filgotinib on ASQoL in AS patients

  11. 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) ]
    To assess safety and tolerability of filgotinib in AS patients

  12. 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) ]
    To assess safety and tolerability of filgotinib in AS patients

  13. 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) ]
    To assess safety and tolerability of filgotinib in AS patients

  14. 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) ]
    To assess safety and tolerability of filgotinib in AS patients

  15. 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) ]
    To assess safety and tolerability of filgotinib in AS patients

  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) ]
    To assess safety and tolerability of filgotinib in AS patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117270


Locations
Belgium
ULB Hopital Erasme, Service de Rheumatology
Brussels, Belgium
Bulgaria
Eurohospital
Plovdiv, Bulgaria
UMHAT Kaspela EOOD
Plovdiv, Bulgaria
Medical Center "Teodora", EOOD
Ruse, 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
Czechia
Revmatologicka ambulance
Ostrava, Czechia
CCBR Czech, a.s
Pardubice, Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, Czechia
Estonia
OÜ Innomedica
Tallinn, Estonia
Poland
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.
Poznań, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Toruń, Poland
Centrum Medyczne AMED, Warszawa Targowek
Warsaw, Poland
Spain
Corporacio Sanitaria Parc Tauli, Servicio de Reumatologia
Santiago de Compostela, Spain
Hospital Infanta Luisa, Servicio de Reumatologia
Sevilla, Spain
Hospital Universitario Virgen Macarena, Dept. of Rheumatology
Sevilla, Spain
Ukraine
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
L'viv, 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
Uzhgorod, Ukraine
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
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
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Vinnytsya, Ukraine
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Pille Harrison, MD, DPhil, MRCP (UK) Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03117270     History of Changes
Other Study ID Numbers: GLPG0634-CL-223
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis