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An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

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ClinicalTrials.gov Identifier: NCT03320876
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:
This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects withmoderately to severely active PsA.It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224.Subjects in the LTE study will be treated with filgotinib for a duration of 148 weeks. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment. Consequently, each subject will stay in the LTE study for a maximum of 152 weeks.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: filgotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: filgotinib Drug: filgotinib
one filgotinib oral tablet once daily.




Primary Outcome Measures :
  1. Change in the proportion of subjects with adverse events. [ Time Frame: Between entry visit and 4 weeks after the last dose. ]
    To asses safety and tolerability of filgotinib.


Secondary Outcome Measures :
  1. Proportion of subjects achieving minimal disease activity (MDA). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on MDA in PsA patients.

  2. Proportion of subjects achieving ACR20 response. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients.

  3. Proportion of subjects achieving ACR50 response. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients.

  4. Proportion of subjects achieving ACR70 response. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients

  5. Proportion of subjects who achieve low disease activity (defined as DAS28[CRP] <=3.2) and remission (defined as DAS28[CRP]<2.6). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients.

  6. Change from core baseline in Spondylitis Disease Activity Index response(SDAI) [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients.

  7. Change from core baseline in Clinical Disease Activity Index (CDAI). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients.

  8. Assessment of EULAR response and remission rates. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients.

  9. Assessment of Psoriatic arthritis response criteria (PsARC). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filogotinib on PsARC in PsA patients.

  10. Change from core baseline in Psoriasis Area and Severity Index (PASI). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on PASI in PsA patients.

  11. Proportion of subjects with PASI50. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on PASI50 in PsA patients.

  12. Proportion of subjects with PASI75. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on PASI75 in PsA patients.

  13. Proportion of subjects with PASI90. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on PASI90 in PsA patients.

  14. Proportion of subjects with PASI100. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on PASI100 in PsA patients.

  15. Change from core baseline in Physician's global assessment of psoriasis. [ Time Frame: At each visit through Week 148. ]
    To assess the affect of filgotinib on Physician's global assessment of psoriasis in PsA patients.

  16. Change from core baseline in Patient's Global Assessment of psoriasis. [ Time Frame: At each visit through Week 148. ]
    To assess the affect of filgotinib on patient's global assessment of psoriasis in PsA patients.

  17. Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on mNAPSI in PsA patients assessment of psoriasis in PsA patients.

  18. Change from core baseline in pruritis numeric rating scale (NRS) [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on NRS in PsA patients.

  19. Proportion of subjects achieving a pruritis numeric rating scale (NRS) response (improvement in pruritus NRS score of >=3) [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on NRS in PsA patients.

  20. Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index. [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients.

  21. Change from core baseline in Leeds Dactylitis Index (LDI). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on Dactilytis in PsA patients.

  22. Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI). [ Time Frame: At each visit through Week 148. ]
    To assess the effect of filgotinib on physical function in PsA patients.

  23. Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale). [ Time Frame: Week 4, Week 52, Week 100, and Week 148. ]
    To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients.

  24. Change from core baseline in 36-item Short-Form Health Survey (SF-36). [ Time Frame: Week 4, Week 52, Week 100, and Week 148. ]
    To assess the effect of filgotinib on SF-36 in PsA patients

  25. Change from core baseline in Psoriatic Arthritis Impact of Disease. Questionnaire (PsAID). [ Time Frame: Week 4, Week 52, Week 100, and Week 148. ]
    To assess the effect of filgotinib on PsAID in PsA patients.

  26. Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria. [ Time Frame: Week 4, Week 52, Week 100, and Week 148. ]
    To assess the effect of filgotinib on signs and symptoms of peripheral arthritis and physical funcion in PsA patients.



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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

Inclusion Criteria:

  • Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator's judgment.
  • Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
  • Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.

Exclusion Criteria:

  • Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
  • Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator's clinical judgment.
  • Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
  • Subjects who require immunization with live/live attenuated vaccine.
  • Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren's syndrome.
  • Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634- CL-224 study.
  • Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
  • Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
  • Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.

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): NCT03320876


Locations
Belgium
ULB Hopital Erasme, Service de Rheumatology
Brussels, Belgium
Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv, Bulgaria
MHAT - Ruse, AD
Ruse, Bulgaria
UMHAT "SofiaMed", OOD, Block 1
Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria
Czechia
CCBR Czech, a.s
Pardubice, Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, Czechia
Estonia
Center for Clinical and Basic Research
Tallinn, Estonia
North Estonia Medical Centre Foundation
Tallinn, Estonia
OÜ Innomedica
Tallinn, Estonia
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
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
Fuenlabrada, Spain
Hospital Infanta Luisa, Servicio de Reumatologia
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
Kyiv, 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
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: NCT03320876     History of Changes
Other Study ID Numbers: GLPG0634-CL-225
2017-000545-52 ( EudraCT Number )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 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:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases