Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    Filgotinib | psoriatic arthritis
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03320876
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : April 17, 2020
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 with moderately 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 will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: N/A
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 : January 2024
Estimated Study Completion Date : January 2024

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 on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on MDA in PsA patients.

  2. Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by ACR20 in PsA patients.

  3. Proportion of subjects achieving ACR50 response [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by ACR50 in PsA patients.

  4. Proportion of subjects achieving ACR70 response [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by ACR70 in PsA patients

  5. Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

  6. Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

  7. Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

  8. Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

  9. Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

  10. Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

  11. Proportion of subjects with DAPSA remission (DAPSA ≤4) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

  12. Change from core baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PASI in PsA patients.

  13. Proportion of subjects with PASI50 [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PASI50 in PsA patients.

  14. Proportion of subjects with PASI75 [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PASI75 in PsA patients.

  15. Proportion of subjects with PASI90 [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PASI90 in PsA patients.

  16. Proportion of subjects with PASI100 [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on PASI100 in PsA patients.

  17. Change from core baseline in Physician's global assessment of psoriasis [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the affect of filgotinib on Physician's global assessment of psoriasis in PsA patients.

  18. Change from core baseline in Patient's Global Assessment of psoriasis [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the affect of filgotinib on patient's global assessment of psoriasis in PsA patients.

  19. Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on mNAPSI in PsA patients assessment of psoriasis in PsA patients.

  20. Change from core baseline in pruritis numeric rating scale (NRS) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on NRS in PsA patients.

  21. Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on NRS in PsA patients.

  22. Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients.

  23. Change from core baseline in Leeds Dactylitis Index (LDI) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on Dactilytis in PsA patients.

  24. Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on physical function in PsA patients.

  25. Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale) [ Time Frame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304. ]
    To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients.

  26. Change from core baseline in 36-item Short-Form Health Survey (SF-36) [ Time Frame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304. ]
    To assess the effect of filgotinib on SF-36 in PsA patients

  27. Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID). [ Time Frame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304. ]
    To assess the effect of filgotinib on PsAID in PsA patients.

  28. Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria [ Time Frame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. ]
    To assess the effect of filgotinib on signs and symptoms of peripheral arthritis and physical function in PsA patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Show Show 25 study locations
Sponsors and Collaborators
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Lien Gheyle, MD Galapagos NV

Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03320876    
Other Study ID Numbers: GLPG0634-CL-225
2017-000545-52 ( EudraCT Number )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases