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A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis (OLINGUITO)

Primary Purpose

Axial Spondyloarthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Filgotinib
Placebo
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring chronic inflammatory disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Have an established diagnosis of axSpA by a rheumatologist (or other specialist with expertise in diagnosing axSpA). Study A (r-axSpA): Meet Assessment of SpondyloArthritis International Society (ASAS) classification criteria with radiographic sacroiliitis on X-ray as follows: History of back pain >=12 weeks and age at onset of back pain <45 years, AND Have radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, based on New York grading system, confirmed by central reading, AND, >=1 spondyloarthritis (SpA) feature. Study B (nr- axSpA): Meet ASAS classification criteria without radiographic sacroiliitis on X-ray as follows: History of back pain >= 12 weeks and age at onset of back pain <45 years, AND No radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, AND, Presence of sacroiliitis on MRI (based on central reading) and at least 1 SpA feature or when positive for human leukocyte antigen (HLA)-B27: having at least 2 SpA features, AND Have objective signs of inflammation, by sacroiliitis on MRI or elevated CRP. Have active axSpA at screening and Day 1 defined by: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 (numeric rating scale [NRS] 0-10), AND Spinal pain score >=4 (0-10 NRS) (based on BASDAI question 2), Have a history of inadequate response to >=2 NSAIDs at the maximum dose of NSAIDs used in axSpA for >=2 weeks each (a total duration of NSAID trial >=4 weeks) or intolerance to >=2 NSAIDs for the treatment of axSpA. Participants who are designated as biologic disease-modifying antirheumatic drug-inadequate responder (bDMARD-IR) must have received not more than 2 approved bDMARD(s), that was/were administered in accordance with its/their labeling and was/were inadequately effective after the minimum treatment of 12 weeks. If continuing conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during the study, participants are permitted to use only a maximum of 2 csDMARDs and must have been on this treatment for >=12 weeks prior to screening, with a stable dose and route of administration (defined as no change in prescription) for >4 weeks prior to Day 1. For participants aged 65 years or above on the date of signing the informed consent form (ICF), the investigator should carefully consider if participation is in the best interest of the participant. Key Exclusion Criteria: Prior exposure to a Janus kinase inhibitor, investigational or approved, at any time, including filgotinib. Use of any opioid analgesic at average daily doses >30 mg/day of morphine (or equivalent) or use of unstable doses of any opioid analgesic <=2 weeks prior to Day 1. Use of any of the following systemic immunomodulating therapies <= 4 weeks prior to Day 1, including, but not limited to: 6-mercaptopurine, azathioprine, cyclosporine or other calcineurin inhibitors (e.g. sirolimus, tacrolimus), methotrexate if being discontinued, mycophenolate, antimalarials (e.g. hydroxychloroquine, chloroquine) if being discontinued, or sulfasalazine if being discontinued. Complete spinal ankylosis defined as the presence of consecutive bridging syndesmophytes in >=5 vertebrae on the lateral radiograph (assessed by the central reader). Have undergone surgical treatments for peripheral manifestation of axSpA, including synovectomy or arthroplasty, or major surgery (requiring regional block or general anesthesia) <=12 weeks prior to Day 1 or planned major surgery during the study. Have a diagnosis of any generalized musculoskeletal disorder, e.g. generalized osteoarthritis, or systemic inflammatory condition other than axSpA. Have active Crohn's disease (CD) or active ulcerative colitis (UC). Note: participants may be enrolled if they have had a history of inflammatory bowel disease (IBD), including CD and UC, but have had no exacerbation within 6 months prior to Day 1, and, if currently on treatment, must be on stable treatment for >=6 months prior to Day 1. Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the participant by participating in the study (e.g. uncontrolled uveitis, uncontrolled thyroiditis, transverse myelitis, current peptic ulcer disease or prior history of severe diverticulitis [i.e. requiring hospitalization] or previous gastrointestinal perforation), per judgment of investigator, History of opportunistic infection, or immunodeficiency syndrome, which would put the participant at risk, as per investigator judgment, Active infection that is clinically significant, as per judgment of the investigator, or history of a serious infection (requiring hospitalization or systemic antibiotics) within 12 weeks prior to screening. Participant has any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. For participants at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past (>10 pack-years) and those at increased risk of cancer, the investigator should carefully consider if participation is in the best interest of the participant. Contraindication to magnetic resonance imaging (MRI).

Sites / Locations

  • ReumaClinicRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • Medical Center RodopimedRecruiting
  • MC Medconsult PlevenRecruiting
  • UMHAT Plovdiv ADRecruiting
  • UMHAT Eurohospital PlovdivRecruiting
  • Medical Center UNIMED EOODRecruiting
  • Medical Center TeodoraRecruiting
  • Medical Center 1 SevlievoRecruiting
  • DCC Ascendent EOODRecruiting
  • UMHAT Sofiamed OODRecruiting
  • Dcc Focus 5 Meoh OodRecruiting
  • Dcc Focus 5 MeohRecruiting
  • DCC XVII-Sofia EOODRecruiting
  • Medical Center HeraRecruiting
  • Medical Center N I PIROGOVRecruiting
  • Military Medical Academy MHATRecruiting
  • UMHAT Stoyan Kirkovich ADRecruiting
  • CHC Rijeka Immunology DepartmentRecruiting
  • Poliklinika BonifarmRecruiting
  • Poliklinika K-CentarRecruiting
  • Lekarna U RevmatologickehoRecruiting
  • Fakultni nemocnice u sv Anny, Interni klinikaRecruiting
  • Revmaclinic s r oRecruiting
  • Lekarna BENURecruiting
  • Revmatologie s r oRecruiting
  • CCR OstravaRecruiting
  • Vesalion Revma ambulanceRecruiting
  • Artroscan s r oRecruiting
  • ARTHROHELP s r oRecruiting
  • CCR Czech a sRecruiting
  • MUDR. Zuzana URBANOVA RevmatologieRecruiting
  • Fakultni nemocnice MotolRecruiting
  • Medical Plus SroRecruiting
  • PV Medical ServicesRecruiting
  • Clinical Research CentreRecruiting
  • Meditrials OURecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Charite Medizinische Klinik IRecruiting
  • University General Hospital "Attikon"Recruiting
  • Revita Rheumatologiai KftRecruiting
  • Vita Verum MedicalRecruiting
  • Istituto Ortopedico RizzoliRecruiting
  • Chonnam National University HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • Konkuk University Medical CenterRecruiting
  • Kyung Hee University Hospital at GangdongRecruiting
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • Kaunas Hospital of LUHSCPRecruiting
  • Kaunas City PolyclinicRecruiting
  • Klaipeda University Hospital, Public InstitutionRecruiting
  • Vilnius UH Santariskiu ClinicsRecruiting
  • Medisch Spectrum TwenteRecruiting
  • UMCGRecruiting
  • Zuyderland Medisch CentrumRecruiting
  • Medisch Centrum LeeuwardenRecruiting
  • Ilocos Training and Regional Medical CenterRecruiting
  • Ospital Ng MakatiRecruiting
  • Lipa Medix Medical CenterRecruiting
  • Mary Mediatrix Medical CenterRecruiting
  • St. Luke's Medical CenterRecruiting
  • Far Eastern University - Dr. Nicanor Reyes Medical FoundationRecruiting
  • ZDROWIE Osteo MedicRecruiting
  • Centrum Kliniczno BadawczeRecruiting
  • Silmedic sp. z o. oRecruiting
  • Reumed Spolka z o oRecruiting
  • KO-MED Centra KliniczneRecruiting
  • Twoja Przychodnia NCMRecruiting
  • ETYKA Osrodek Badan KlinicznycRecruiting
  • TPO Centrum MedyczneRecruiting
  • AI Centrum MedyczneRecruiting
  • Solumed Medical CenterRecruiting
  • Twoja Przychodnia PCMRecruiting
  • KO-MED Centra KliniczneRecruiting
  • MICS Medical Center TorunRecruiting
  • Instytut Reumatologii im. Eleonory ReicherRecruiting
  • Klinika Reuma ParkRecruiting
  • MICS Centrum MedyczneRecruiting
  • ETG WarszawaRecruiting
  • FutureMeds WroclawRecruiting
  • Sj de Urgenta BacauRecruiting
  • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.LRecruiting
  • SC Delta Health Care SRLRecruiting
  • Spitalul Clinic Judetean de UrgentaRecruiting
  • Aqua Med Consulting SRLRecruiting
  • SC Medisof Diagnostic SRLRecruiting
  • Sc Medaudio Optica SrlRecruiting
  • Clinresco Centres Pty Ltd,Recruiting
  • Arthritis Clinical Trial CentreRecruiting
  • Emmed ResearchRecruiting
  • Winelands Medical Research CentreRecruiting
  • Hospital Marina BaixaRecruiting
  • UH Parc TauliRecruiting
  • HU Reina SofiaRecruiting
  • Hospital Universitario La PazRecruiting
  • HU Marques de ValdecillaRecruiting
  • Clinica GAIAS SantiagoRecruiting
  • HU Virgen MacarenaRecruiting
  • Kaohsiung Veterans General HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Radiographic Part (Study A) Filgotinib

Non-radiographic Part (Study B) Filgotinib

Arm Description

Participants will receive filgotinib 200 mg or placebo to match filgotinib. Participants will receive blinded treatment until Week 16. After that participants with an age under 65 and without certain health risks will enter open label period and will receive filgotinib 200 mg until Week 52. Participants reaching an Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at weeks 40 and 52, will enter dose de-escalation phase and will be randomized to filgotinib 200 or 100 mg until Week 104. Participants, with an age of 65 or above or with certain health risks, will enter open label period until Week 104 and will receive 100 or 200 mg filgotinib a day, depending on their axSpA symptoms. The maximum duration of treatment period will be up to Week 104.

Participants will receive filgotinib 200 mg or placebo to match filgotinib. Participants will receive blinded treatment until Week 16. After that participants with an age under 65 and without certain health risks will enter open label period and will receive filgotinib 200 mg until Week 52. Participants reaching an ASDAS <2.1 at weeks 40 and 52, will enter dose de-escalation phase and will be randomized to filgotinib 200 or 100 mg until Week 104. Participants, with an age of 65 or above or with certain health risks, will enter open label period until Week 104 and will receive 100 or 200 mg filgotinib a day, depending on their axSpA symptoms. The maximum duration of treatment period will be up to Week 104.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving SpondyloArthritis International Society 40% improvement (ASAS40) Response (Yes/No) at Week 16

Secondary Outcome Measures

Change from baseline in Ankylosing Spondylitis DiseaseActivity Score with C-reactive protein (ASDASCRP) at Week 16
Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score of Sacroiliac Joints (SIJs) at Week 16
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score) at Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TE Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation at Week 16

Full Information

First Posted
March 14, 2023
Last Updated
September 29, 2023
Sponsor
Galapagos NV
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1. Study Identification

Unique Protocol Identification Number
NCT05785611
Brief Title
A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
Acronym
OLINGUITO
Official Title
A Phase 3 Randomized, Placebo-controlled, Double-blind, Parallel-group Program to Evaluate Efficacy and Safety of Filgotinib in Adult Subjects With Active Axial Spondyloarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use. The study will also be comparing 200 mg with 100 mg filgotinib a day to see if the lower dose also helps to treat axSpA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
chronic inflammatory disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiographic Part (Study A) Filgotinib
Arm Type
Experimental
Arm Description
Participants will receive filgotinib 200 mg or placebo to match filgotinib. Participants will receive blinded treatment until Week 16. After that participants with an age under 65 and without certain health risks will enter open label period and will receive filgotinib 200 mg until Week 52. Participants reaching an Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at weeks 40 and 52, will enter dose de-escalation phase and will be randomized to filgotinib 200 or 100 mg until Week 104. Participants, with an age of 65 or above or with certain health risks, will enter open label period until Week 104 and will receive 100 or 200 mg filgotinib a day, depending on their axSpA symptoms. The maximum duration of treatment period will be up to Week 104.
Arm Title
Non-radiographic Part (Study B) Filgotinib
Arm Type
Experimental
Arm Description
Participants will receive filgotinib 200 mg or placebo to match filgotinib. Participants will receive blinded treatment until Week 16. After that participants with an age under 65 and without certain health risks will enter open label period and will receive filgotinib 200 mg until Week 52. Participants reaching an ASDAS <2.1 at weeks 40 and 52, will enter dose de-escalation phase and will be randomized to filgotinib 200 or 100 mg until Week 104. Participants, with an age of 65 or above or with certain health risks, will enter open label period until Week 104 and will receive 100 or 200 mg filgotinib a day, depending on their axSpA symptoms. The maximum duration of treatment period will be up to Week 104.
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Other Intervention Name(s)
GS-6034, GLPG0634
Intervention Description
Tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving SpondyloArthritis International Society 40% improvement (ASAS40) Response (Yes/No) at Week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in Ankylosing Spondylitis DiseaseActivity Score with C-reactive protein (ASDASCRP) at Week 16
Time Frame
Week 16
Title
Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score of Sacroiliac Joints (SIJs) at Week 16
Time Frame
Week 16
Title
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
Time Frame
Week 16
Title
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
Time Frame
Week 16
Title
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score) at Week 16
Time Frame
Week 16
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), TE Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation at Week 16
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Have an established diagnosis of axSpA by a rheumatologist (or other specialist with expertise in diagnosing axSpA). Study A (r-axSpA): Meet Assessment of SpondyloArthritis International Society (ASAS) classification criteria with radiographic sacroiliitis on X-ray as follows: History of back pain >=12 weeks and age at onset of back pain <45 years, AND Have radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, based on New York grading system, confirmed by central reading, AND, >=1 spondyloarthritis (SpA) feature. Study B (nr- axSpA): Meet ASAS classification criteria without radiographic sacroiliitis on X-ray as follows: History of back pain >= 12 weeks and age at onset of back pain <45 years, AND No radiographic bilateral grade 2-4 sacroiliitis or unilateral grade 3-4 sacroiliitis, AND, Presence of sacroiliitis on MRI (based on central reading) and at least 1 SpA feature or when positive for human leukocyte antigen (HLA)-B27: having at least 2 SpA features, AND Have objective signs of inflammation, by sacroiliitis on MRI or elevated CRP. Have active axSpA at screening and Day 1 defined by: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 (numeric rating scale [NRS] 0-10), AND Spinal pain score >=4 (0-10 NRS) (based on BASDAI question 2), Have a history of inadequate response to >=2 NSAIDs at the maximum dose of NSAIDs used in axSpA for >=2 weeks each (a total duration of NSAID trial >=4 weeks) or intolerance to >=2 NSAIDs for the treatment of axSpA. Participants who are designated as biologic disease-modifying antirheumatic drug-inadequate responder (bDMARD-IR) must have received not more than 2 approved bDMARD(s), that was/were administered in accordance with its/their labeling and was/were inadequately effective after the minimum treatment of 12 weeks. If continuing conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) during the study, participants are permitted to use only a maximum of 2 csDMARDs and must have been on this treatment for >=12 weeks prior to screening, with a stable dose and route of administration (defined as no change in prescription) for >4 weeks prior to Day 1. For participants aged 65 years or above on the date of signing the informed consent form (ICF), the investigator should carefully consider if participation is in the best interest of the participant. Key Exclusion Criteria: Prior exposure to a Janus kinase inhibitor, investigational or approved, at any time, including filgotinib. Use of any opioid analgesic at average daily doses >30 mg/day of morphine (or equivalent) or use of unstable doses of any opioid analgesic <=2 weeks prior to Day 1. Use of any of the following systemic immunomodulating therapies <= 4 weeks prior to Day 1, including, but not limited to: 6-mercaptopurine, azathioprine, cyclosporine or other calcineurin inhibitors (e.g. sirolimus, tacrolimus), methotrexate if being discontinued, mycophenolate, antimalarials (e.g. hydroxychloroquine, chloroquine) if being discontinued, or sulfasalazine if being discontinued. Complete spinal ankylosis defined as the presence of consecutive bridging syndesmophytes in >=5 vertebrae on the lateral radiograph (assessed by the central reader). Have undergone surgical treatments for peripheral manifestation of axSpA, including synovectomy or arthroplasty, or major surgery (requiring regional block or general anesthesia) <=12 weeks prior to Day 1 or planned major surgery during the study. Have a diagnosis of any generalized musculoskeletal disorder, e.g. generalized osteoarthritis, or systemic inflammatory condition other than axSpA. Have active Crohn's disease (CD) or active ulcerative colitis (UC). Note: participants may be enrolled if they have had a history of inflammatory bowel disease (IBD), including CD and UC, but have had no exacerbation within 6 months prior to Day 1, and, if currently on treatment, must be on stable treatment for >=6 months prior to Day 1. Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the participant by participating in the study (e.g. uncontrolled uveitis, uncontrolled thyroiditis, transverse myelitis, current peptic ulcer disease or prior history of severe diverticulitis [i.e. requiring hospitalization] or previous gastrointestinal perforation), per judgment of investigator, History of opportunistic infection, or immunodeficiency syndrome, which would put the participant at risk, as per investigator judgment, Active infection that is clinically significant, as per judgment of the investigator, or history of a serious infection (requiring hospitalization or systemic antibiotics) within 12 weeks prior to screening. Participant has any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. For participants at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past (>10 pack-years) and those at increased risk of cancer, the investigator should carefully consider if participation is in the best interest of the participant. Contraindication to magnetic resonance imaging (MRI).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galapagos Medical Information
Phone
+3215342900
Email
medicalinfo@glpg.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
ReumaClinic
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Medical Center Rodopimed
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MC Medconsult Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Plovdiv AD
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Eurohospital Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center UNIMED EOOD
City
Plovdiv
ZIP/Postal Code
4023
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Teodora
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center 1 Sevlievo
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC Ascendent EOOD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sofiamed OOD
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dcc Focus 5 Meoh Ood
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dcc Focus 5 Meoh
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC XVII-Sofia EOOD
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hera
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center N I PIROGOV
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Military Medical Academy MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Stoyan Kirkovich AD
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
CHC Rijeka Immunology Department
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Poliklinika Bonifarm
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Poliklinika K-Centar
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Lekarna U Revmatologickeho
City
Prague
State/Province
Nove Mesto
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice u sv Anny, Interni klinika
City
Brno
ZIP/Postal Code
60 200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmaclinic s r o
City
Brno
ZIP/Postal Code
60 200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Lekarna BENU
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologie s r o
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Ostrava
City
Ostrava
ZIP/Postal Code
70 200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vesalion Revma ambulance
City
Ostrava
ZIP/Postal Code
70 200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Artroscan s r o
City
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
ARTHROHELP s r o
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Czech a s
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDR. Zuzana URBANOVA Revmatologie
City
Prague
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Motol
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Medical Plus Sro
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
PV Medical Services
City
Zlín
ZIP/Postal Code
76001
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Clinical Research Centre
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Meditrials OU
City
Tartu
ZIP/Postal Code
50708
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Charite Medizinische Klinik I
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
University General Hospital "Attikon"
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Revita Rheumatologiai Kft
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Vita Verum Medical
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kaunas Hospital of LUHSCP
City
Kaunas
ZIP/Postal Code
45130
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Kaunas City Polyclinic
City
Kaunas
ZIP/Postal Code
51270
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Klaipeda University Hospital, Public Institution
City
Klaipėda
ZIP/Postal Code
92288
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Vilnius UH Santariskiu Clinics
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7512 AV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713 AP
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Ilocos Training and Regional Medical Center
City
San Fernando
State/Province
La Union
ZIP/Postal Code
2500
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Ospital Ng Makati
City
Makati City
State/Province
Metro Manila
ZIP/Postal Code
1218
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Lipa Medix Medical Center
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Mary Mediatrix Medical Center
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Individual Site Status
Recruiting
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
City
Quezon City
ZIP/Postal Code
1118
Country
Philippines
Individual Site Status
Recruiting
Facility Name
ZDROWIE Osteo Medic
City
Bialystok
ZIP/Postal Code
15 351
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82 300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Silmedic sp. z o. o
City
Katowice
ZIP/Postal Code
40282
Country
Poland
Individual Site Status
Recruiting
Facility Name
Reumed Spolka z o o
City
Lubin
ZIP/Postal Code
20607
Country
Poland
Individual Site Status
Recruiting
Facility Name
KO-MED Centra Kliniczne
City
Lublin
ZIP/Postal Code
21-362
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia NCM
City
Nowa Sol
ZIP/Postal Code
67 100
Country
Poland
Individual Site Status
Recruiting
Facility Name
ETYKA Osrodek Badan Klinicznyc
City
Olsztyn
ZIP/Postal Code
10 117
Country
Poland
Individual Site Status
Recruiting
Facility Name
TPO Centrum Medyczne
City
Opole
ZIP/Postal Code
45 819
Country
Poland
Individual Site Status
Recruiting
Facility Name
AI Centrum Medyczne
City
Poznan
ZIP/Postal Code
61 113
Country
Poland
Individual Site Status
Recruiting
Facility Name
Solumed Medical Center
City
Poznań
ZIP/Postal Code
60529
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia PCM
City
Poznań
ZIP/Postal Code
61 293
Country
Poland
Individual Site Status
Recruiting
Facility Name
KO-MED Centra Kliniczne
City
Staszów
ZIP/Postal Code
28 200
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Medical Center Torun
City
Toruń
ZIP/Postal Code
87 100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Reumatologii im. Eleonory Reicher
City
Warsawa
ZIP/Postal Code
02 637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Reuma Park
City
Warsawa
ZIP/Postal Code
02665
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne
City
Warszawa
ZIP/Postal Code
00 874
Country
Poland
Individual Site Status
Recruiting
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02 793
Country
Poland
Individual Site Status
Recruiting
Facility Name
FutureMeds Wroclaw
City
Wrocław
ZIP/Postal Code
50 088
Country
Poland
Individual Site Status
Recruiting
Facility Name
Sj de Urgenta Bacau
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Individual Site Status
Recruiting
Facility Name
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
City
Braşov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Delta Health Care SRL
City
Bucharest
ZIP/Postal Code
14142
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Judetean de Urgenta
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Individual Site Status
Recruiting
Facility Name
Aqua Med Consulting SRL
City
Constanta
ZIP/Postal Code
900612
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Medisof Diagnostic SRL
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Name
Sc Medaudio Optica Srl
City
Ramnicu Valcea
ZIP/Postal Code
240762
Country
Romania
Individual Site Status
Recruiting
Facility Name
Clinresco Centres Pty Ltd,
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Arthritis Clinical Trial Centre
City
Pinelands
ZIP/Postal Code
7405
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Marina Baixa
City
Alicante
ZIP/Postal Code
03570
Country
Spain
Individual Site Status
Recruiting
Facility Name
UH Parc Tauli
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
HU Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28 046
Country
Spain
Individual Site Status
Recruiting
Facility Name
HU Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica GAIAS Santiago
City
Santiago De Compostela
ZIP/Postal Code
15702
Country
Spain
Individual Site Status
Recruiting
Facility Name
HU Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Hospital
City
Taipei city
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

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