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

April 20, 2022 updated by: Galapagos NV

A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • ULB Hopital Erasme, Service de Rheumatology
  • Bulgaria
      • Plovdiv, Bulgaria
        • UMHAT "Kaspela", EOOD
      • Ruse, Bulgaria
        • MHAT - Ruse, AD
      • Sofia, Bulgaria
        • UMHAT "SofiaMed", OOD, Block 1
      • Sofia, Bulgaria
        • UMHAT "Sv. Ivan Rilski", EAD
  • Czechia
      • Pardubice, Czechia
        • CCBR Czech, a.s
      • Uherské Hradiště, Czechia
        • MEDICAL Plus s.r.o.
  • Estonia
      • Tallinn, Estonia
        • North Estonia Medical Centre Foundation
      • Tallinn, Estonia
        • OU Innomedica
      • Tallinn, Estonia
        • Center for Clinical and Basic Research
  • Poland
      • Nowa Sól, Poland
        • Twoja Przychodnia-Centrum Medyczne Nowa Sol
      • Poznań, Poland
        • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
      • Toruń, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
      • Warsaw, Poland
        • Centrum Medyczne AMED, Warszawa Targowek
  • Spain
      • Fuenlabrada, Spain
        • Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
      • Sevilla, Spain
        • Hospital Infanta Luisa, Servicio de Reumatologia
  • Ukraine
      • Kharkiv, Ukraine
        • CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
      • Kiev, Ukraine
        • CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
      • Kyiv, Ukraine
        • SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
      • L'viv, Ukraine
        • CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
      • Poltava, Ukraine
        • M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
      • Ternopil', Ukraine
        • CI of TRC
      • Vinnytsia, 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
      • Vinnytsya, Ukraine
        • MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: filgotinib
Drug: filgotinib
one filgotinib oral tablet once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Between entry visit and 4 weeks after the last dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
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.
W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
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
W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
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.
W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
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.
At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galapagos NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vijay Rajendran, MD, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLPG0634-CL-225
  • 2017-000545-52 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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