Psoriatic ArthritisPhase 2EQUATORNCT03101670
A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis
A Phase 2 study testing filgotinib in people with Psoriatic Arthritis, run by Lakefront Biotherapeutics NV at 25 sites in 7 countries.
Trial summary
This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 9 Mar 2017to 12 Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
- Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
- Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count [SJC]) and ≥5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
- Have had a history of documented plaque psoriasis or currently active plaque psoriasis
- If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
- If using non-drug therapies (including physical therapies), thse should be kept sable 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
Who cannot join
- 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 cyclooxygenase-2 (COX-2) inhibitor.
- Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
- Presence of very poor functional status or unable to perform self-care.
- Administration of a live or attenuated vaccine within 12 weeks prior to baseline
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Ukraine9 sites
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
Kharkiv
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
Kiev
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
Kiev
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
Lviv
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
Poltava
CI of TRC
Ternopil
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
Vinnytsia
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Vinnytsia
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
Vinnytsia
Bulgaria4 sites
UMHAT "Kaspela", EOOD
Plovdiv
MHAT - Ruse, AD
Rousse
UMHAT "SofiaMed", OOD, Block 1
Sofia
UMHAT "Sv. Ivan Rilski", EAD
Sofia
Poland4 sites
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Nowa Sól
Ai Centrum Medyczne sp. z o.o. sp.k.
Poznan
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Torun
Centrum Medyczne AMED, Warszawa Targowek
Warsaw
Estonia3 sites
Center for Clinical and Basic Research
Tallinn
North Estonia Medical Centre Foundation
Tallinn
OÜ Innomedica
Tallinn
Spain2 sites
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
Fuenlabrada
Hospital Infanta Luisa, Servicio de Reumatologia
Seville
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis
This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).
- Conditions
- Psoriatic Arthritis
- Being tested
- filgotinib, Placebo Oral Tablet
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgotinibDrug
one filgotinib oral tablet q.d.
Placebo Oral TabletDrug
one placebo oral tablet q.d.
| Study group | Role | What they receive |
|---|---|---|
| filgotinib | Experimental | Not described Receives: Drug: filgotinib |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who have reached ACR20 response as compared to placebo
To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients
Measured: Week 16
Secondary outcomes (32)
Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo
To assess the effect of filogotinib on MDA in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects who have reached ACR50 response as compared to placebo
To assess the effect of filogotinib on PsA as assessed by ACR50 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects who have reached ACR70 response as compared to placebo
To assess the effect of filogotinib on PsA as assessed by ACR70 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving DAS28(CRP) score as compared to placebo
To assess the effect of filogotinib on PsA as assessed by DAS28 (CRP) in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving SDAI response as compared to placebo
To assess the effect of filogotinib on PsA as assessed by SDAI response in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving CDAI response as compared to placebo
To assess the effect of filgotinib on PsA as assessed by CDAI response in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving EULAR response as compared to placebo
To assess the effect of filogotinib on PsA as assessed by EULAR response in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo
To assess the effect of filogotinib on PsARC in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of physician's and patient's global assessment of disease activity as compared to placebo
To assess the effect of filogotinib on physician's and patient's global assessment of disease activity in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo
To assess the effect of filogotinib on on PsA pain intensity in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on joint tenderness and swelling in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of CRP in filgotinib treated subjects as compared to placebo
To assess the effect of filogotinib on CRP in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on PASI in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on PASI50 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo
To assess the affect of filgotinib on PASI75 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo
To assess the affect of filgotinib on PASI90 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo
To assess the affect of filgotinib on PASI100 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo
To assess the affect of filgotinib on Physician's and patient's global assessment of psoriasis in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of mNAPSI in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on mNAPSI in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on NRS in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on Dactilytis in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on physical function in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of SF-36 in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on SF-36 in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo
To assess the effect of filgotinib on PsAID in PsA patients
Measured: At each visit from screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events
To evaluation safety and tolerability of filgotinib in PsA patients
Measured: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations
To evaluation safety and tolerability of filgotinib in PsA patients
Measured: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
To evaluation safety and tolerability of filgotinib in PsA patients
Measured: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
To evaluation safety and tolerability of filgotinib in PsA patients
Measured: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG
To evaluation safety and tolerability of filgotinib in PsA patients
Measured: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment
To evaluation safety and tolerability of filgotinib in PsA patients
Measured: From screening until the final follow up visit (week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start9 Mar 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pille Harrison, MD, DPhil, MRCP (UK), Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101670
- Sponsor's protocol ID
- GLPG0634-CL-224
- Acronym
- EQUATOR
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chandran V, Malkov VA, Ito KL, Liu Y, Vestergaard L, Yoon OK, Liu J, Trivedi M, Hertz A, Gladman D. Pharmacodynamic effects of filgotinib treatment driving clinical improvement in patients with active psoriatic arthritis enrolled in the EQUATOR trial. RMD Open. 2023 Nov;9(4):e003550. doi: 10.1136/rmdopen-2023-003550.
PubMed 37945284Orbai AM, Ogdie A, Gossec L, Tillett W, Leung YY, Gao J, Trivedi M, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Coates LC. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). Rheumatology (Oxford). 2020 Jul 1;59(7):1495-1504. doi: 10.1093/rheumatology/kez408.
PubMed 31624837Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, Abi-Saab W, Tasset C, Meuleners L, Harrison P, Besuyen R, Van der Aa A, Mozaffarian N, Greer JM, Kunder R, Van den Bosch F, Gladman DD. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2367-2377. doi: 10.1016/S0140-6736(18)32483-8. Epub 2018 Oct 22.
PubMed 30360969
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT03101670
- Acronym / sponsor ID
- EQUATOR / GLPG0634-CL-224
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| filgotinib | Experimental | Drug: filgotinib |
| placebo | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
- Diagnosis of psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
- Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count [SJC]) and ≥5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
- Have had a history of documented plaque psoriasis or currently active plaque psoriasis
- If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
Key exclusion criteria (8 listed)
- 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 cyclooxygenase-2 (COX-2) inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgotinibone filgotinib oral tablet q.d. | Drug | filgotinib |
| Placebo Oral Tabletone placebo oral tablet q.d. | Drug | placebo |
Primary outcome
Percentage of subjects who have reached ACR20 response as compared to placebo
Time frame: Week 16
To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients
32 secondary outcomes
Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects who have reached ACR50 response as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects who have reached ACR70 response as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving DAS28(CRP) score as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving SDAI response as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving CDAI response as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Percentage of subjects achieving EULAR response as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of physician's and patient's global assessment of disease activity as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of CRP in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of mNAPSI in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of SF-36 in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo
Time frame: At each visit from screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events
Time frame: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations
Time frame: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs
Time frame: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination
Time frame: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG
Time frame: From screening until the final follow up visit (week 20)
Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment
Time frame: From screening until the final follow up visit (week 20)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Derived from this study: PubMed 37945284Chandran V, Malkov VA, Ito KL, Liu Y, Vestergaard L, Yoon OK, Liu J, Trivedi M, Hertz A, Gladman D. Pharmacodynamic effects of filgotinib treatment driving clinical improvement in patients with active psoriatic arthritis enrolled in the EQUATOR trial. RMD Open. 2023 Nov;9(4):e003550. doi: 10.1136/rmdopen-2023-003550.
- Derived from this study: PubMed 31624837Orbai AM, Ogdie A, Gossec L, Tillett W, Leung YY, Gao J, Trivedi M, Tasset C, Meuleners L, Besuyen R, Hendrikx T, Coates LC. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). Rheumatology (Oxford). 2020 Jul 1;59(7):1495-1504. doi: 10.1093/rheumatology/kez408.
- Derived from this study: PubMed 30360969Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, Abi-Saab W, Tasset C, Meuleners L, Harrison P, Besuyen R, Van der Aa A, Mozaffarian N, Greer JM, Kunder R, Van den Bosch F, Gladman DD. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active psoriatic arthritis (EQUATOR): results from a randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Dec 1;392(10162):2367-2377. doi: 10.1016/S0140-6736(18)32483-8. Epub 2018 Oct 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pille Harrison, MD, DPhil, MRCP (UK) study director
Lakefront Biotherapeutics NV
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgotinib in people with Psoriatic Arthritis, run by Lakefront Biotherapeutics NV at 25 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Ukraine, Bulgaria, Poland, Estonia, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who have reached ACR20 response as compared to placebo (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03101670, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.