Clinical Trials List
Protocol NumberGS-US-431-4566
NCT Number(ClinicalTrials.gov Identfier)NCT04115748
2020-02-27 - 2024-01-31
Phase III
Terminated13
ICD-10L40.59
Other psoriatic arthropathy
A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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Co-Principal Investigator
- 曾文逸 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Shue-Fen Lo Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- TianMing Zhan Division of Rheumatology
- Chang-Fu Kuo Division of Rheumatology
- 張哲慈 Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張婷惠 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wei-Ting Tu Division of Dermatology
- 李兆甯 Division of Dermatology
- Meng-Yu Weng Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 洪維廷 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- 譚國棟 Division of Rheumatology
- 林靖才 Division of Rheumatology
- Yi-Hsing Chen Division of Rheumatology
- 賴國隆 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 陳柏樺 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Tzn-Min Lin 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Active Psoriatic Arthritis
Objectives
The primary objective of this study is:
To evaluate the effect of filgotinib compared to placebo in active PsA as assessed by the
ACR20 response at Week 12
The secondary objectives of this study are:
To evaluate the effect of filgotinib on core domains of PsA (e.g. peripheral arthritis, psoriatic
skin disease, enthesitis and dactylitis) as assessed by MDA, VLDA, ACR responses, PASI
including BSA responses, SPARCC Enthesitis Index and LEI, LDI, PASDAS, DAPSA,
mNAPSI, and PhGAP.
To evaluate the effect of filgotinib on physical function in active PsA as assessed by
HAQ-DI
To evaluate the effect of filgotinib on preservation of joint structure as measured by change
from Baseline in mTSS at Week 24
To evaluate the effect of filgotinib on fatigue and quality of life in active PsA as assessed by
FACIT-Fatigue, SF-36v2, and PsAID-12
To evaluate the efficacy of filgotinib versus adalimumab in active PsA as assessed by
ACR20
To evaluate the safety and tolerability of filgotinib
Test Drug
(1) Filgotinib; (2) Adalimumab
Active Ingredient
(1) Filgotinib
(2) Adalimumab
(2) Adalimumab
Dosage Form
tablet
IVT
IVT
Dosage
100mg/ 200mg
40 mg/0.4mL
40 mg/0.4mL
Endpoints
The primary objective of this study is:
To evaluate the effect of filgotinib compared to placebo in active
psoriatic arthritis (PsA) as assessed by the American College of
Rheumatology 20% improvement (ACR20) response at Week 12
Secondary objectives of this study are:
To evaluate the effect of filgotinib on core domains of PsA as
assessed by Minimal Disease Activity (MDA) and Very Low
Disease Activity (VLDA), ACR responses, Psoriasis Area and
Severity Index including Body Surface Area (PASI including
BSA) responses, Spondyloarthritis Research Consortium of
Canada Enthesitis Index and Leeds Enthesitis Index (SPARCC
Enthesitis Index and LEI), Leeds Dactylitis Index (LDI), Psoriatic
Arthritis Disease Activity Score (PASDAS), Disease Activity
Index for Psoriatic Arthritis (DAPSA), Modified Nail Psoriasis
Severity Index (mNAPSI), and Physician’s Global Assessment of
Psoriasis (PhGAP)
To evaluate the effect of filgotinib on physical function in active
PsA as assessed by Health Assessment Questionnaire – Disability
Index (HAQ-DI)
To evaluate the effect of filgotinib on fatigue and quality of life in
active PsA as assessed by Functional Assessment of Chronic
Illness Therapy – Fatigue Scale (FACIT-Fatigue), 36-item
Short-Form Health Survey Version 2 (SF-36v2), and 12-item
Psoriatic Arthritis Impact of Disease (PsAID-12)
To evaluate the efficacy of filgotinib versus adalimumab in active
PsA as assessed by ACR20 response
To evaluate the safety and tolerability of filgotinib
See Section 2 for full list of study objectives
To evaluate the effect of filgotinib compared to placebo in active
psoriatic arthritis (PsA) as assessed by the American College of
Rheumatology 20% improvement (ACR20) response at Week 12
Secondary objectives of this study are:
To evaluate the effect of filgotinib on core domains of PsA as
assessed by Minimal Disease Activity (MDA) and Very Low
Disease Activity (VLDA), ACR responses, Psoriasis Area and
Severity Index including Body Surface Area (PASI including
BSA) responses, Spondyloarthritis Research Consortium of
Canada Enthesitis Index and Leeds Enthesitis Index (SPARCC
Enthesitis Index and LEI), Leeds Dactylitis Index (LDI), Psoriatic
Arthritis Disease Activity Score (PASDAS), Disease Activity
Index for Psoriatic Arthritis (DAPSA), Modified Nail Psoriasis
Severity Index (mNAPSI), and Physician’s Global Assessment of
Psoriasis (PhGAP)
To evaluate the effect of filgotinib on physical function in active
PsA as assessed by Health Assessment Questionnaire – Disability
Index (HAQ-DI)
To evaluate the effect of filgotinib on fatigue and quality of life in
active PsA as assessed by Functional Assessment of Chronic
Illness Therapy – Fatigue Scale (FACIT-Fatigue), 36-item
Short-Form Health Survey Version 2 (SF-36v2), and 12-item
Psoriatic Arthritis Impact of Disease (PsAID-12)
To evaluate the efficacy of filgotinib versus adalimumab in active
PsA as assessed by ACR20 response
To evaluate the safety and tolerability of filgotinib
See Section 2 for full list of study objectives
Inclution Criteria
1. Male or female subjects who are 18-75 years of age (20-75 years of age at sites in Taiwan), on the day of signing initial informed consent
2. Meet CASPAR and have a history consistent with PsA ≥6 months at Screening
3. Have active PsA defined as ≥3 swollen joints (from a 66 SJC) and ≥3 tender joints (from a 68 TJC) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1
4. Must have a documented history or active signs of at least one of the following at Screening:
a) Plaque psoriasis
b) Nail changes attributed to psoriasis
5. Acceptable baseline X-rays for each of the following: right hand / wrist, left hand / wrist, right foot, left foot, as determined by central imaging
6. Meet at least one of the following at Screening:
a) ≥1 documented joint erosion on radiographs of the hands, wrists or feet by central reading
b) Serum CRP ≥6 mg / L based on central laboratory
7. Have had inadequate response or intolerance to ≥1 csDMARD, apremilast and / or NSAID, administered over the course of ≥12 weeks for the treatment of PsA, as per local guidelines / standard of care
8. If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum of 2 of the following drugs and must have been on this treatment for ≥12 consecutive 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:
a) MTX oral or SC up to 25 mg / week (must include concomitant use of a folic / folinic acid supplementation as per local standard of care / investigator judgment; MTX use maynot be combined with leflunomide during the study)
b) Leflunomide up to 20 mg once daily orally (may not be combined with MTX during the study)
c) Sulfasalazine up to 3 g daily orally
d) Hydroxychloroquine up to 400 mg daily or chloroquine up to 250 mg daily
e) Apremilast up to 30 mg twice daily orally
f) Azathioprine up to 200 mg daily orally
g) Cyclosporine up to 300 mg daily orally
9. If csDMARDs are stopped prior to Day 1, the following washout periods are required:
a) ≥4 weeks prior to Day 1: apremilast, sulfasalazine, azathioprine, MTX, hydroxychloroquine
b) ≥8 weeks prior to Day 1: oral cyclosporine
c) Leflunomide must either have a washout period of ≥8 weeks prior to Day 1 or ≥4 weeks prior to Day 1 if 11 days of standard cholestyramine therapy was completed
10. If taking NSAIDs, dose must be kept stable (defined as no change in prescription) for ≥2 weeks prior to Day 1
11. If taking oral corticosteroids, dose must be ≤10 mg / day of prednisone or equivalent, and be kept at a stable dose (defined as no change in prescription) for ≥4 weeks prior to Day 1
12. If using topical therapies for psoriasis (e.g. topical corticosteroids, coal tar, salicylic acid, vitamin D analogs, retinoids, anthralin, topical calcineurin inhibitors such as tacrolimus) dose must be stable (defined as no change in prescription) ≥2 weeks prior to Day 1
13. Meet one of the following TB Screening criteria:
a) No evidence of active or latent TB, which is defined as having ALL of the following:
i. A negative QuantiFERON® TB-Gold In-Tube test at Screening
AND
ii. A chest radiograph (views as per local guidelines) taken at Screening or within the 3 months prior to Screening (with the report or films available for investigator review) without evidence of active or latent TB infection
AND
iii. No history of either untreated or inadequately treated latent or active TB infection
b) For subjects with prior latent TB:
i. A completed course of therapy, as per local standard of care, for latent TB (9 months of isoniazid in a location where rates of primary multi-drug resistant TB infections are <5% or an acceptable alternative regimen) WITH a chest X-ray within 3 months prior to or at Screening
In these cases, no QuantiFERON® TB-Gold In-Tube test (or equivalent assay) need be obtained. A chest radiograph with the report or films must be available for investigator review.
NOTE: Cases falling under category “b” need to be approved in writing by the Sponsor or its designee prior to enrollment in the study. Subjects with currently ACTIVE TB are not allowed in the study, regardless of past or present anti-TB medication use. Subjects with a new diagnosis of latent TB during screening are not allowed in the study until completion of latent TB treatment is documented.
14. Able and willing to sign the informed consent as approved by IRB / IEC. Written consent must be provided before initiating any Screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments. Subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
15. Able and willing to perform SC self-injections or have a caregiver able, willing, and available to administer the injections
16. Subjects receiving non-prohibited medication for any reason should be on a stable dose (defined as no change in prescription and stable per investigator judgment) prior to the first administration of study drug on Day 1
17. A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy test result at the Day 1 Visit are required for female subjects of child bearing potential
18. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
19. Lactating females must agree to discontinue nursing before the study drug is administered
2. Meet CASPAR and have a history consistent with PsA ≥6 months at Screening
3. Have active PsA defined as ≥3 swollen joints (from a 66 SJC) and ≥3 tender joints (from a 68 TJC) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1
4. Must have a documented history or active signs of at least one of the following at Screening:
a) Plaque psoriasis
b) Nail changes attributed to psoriasis
5. Acceptable baseline X-rays for each of the following: right hand / wrist, left hand / wrist, right foot, left foot, as determined by central imaging
6. Meet at least one of the following at Screening:
a) ≥1 documented joint erosion on radiographs of the hands, wrists or feet by central reading
b) Serum CRP ≥6 mg / L based on central laboratory
7. Have had inadequate response or intolerance to ≥1 csDMARD, apremilast and / or NSAID, administered over the course of ≥12 weeks for the treatment of PsA, as per local guidelines / standard of care
8. If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum of 2 of the following drugs and must have been on this treatment for ≥12 consecutive 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:
a) MTX oral or SC up to 25 mg / week (must include concomitant use of a folic / folinic acid supplementation as per local standard of care / investigator judgment; MTX use maynot be combined with leflunomide during the study)
b) Leflunomide up to 20 mg once daily orally (may not be combined with MTX during the study)
c) Sulfasalazine up to 3 g daily orally
d) Hydroxychloroquine up to 400 mg daily or chloroquine up to 250 mg daily
e) Apremilast up to 30 mg twice daily orally
f) Azathioprine up to 200 mg daily orally
g) Cyclosporine up to 300 mg daily orally
9. If csDMARDs are stopped prior to Day 1, the following washout periods are required:
a) ≥4 weeks prior to Day 1: apremilast, sulfasalazine, azathioprine, MTX, hydroxychloroquine
b) ≥8 weeks prior to Day 1: oral cyclosporine
c) Leflunomide must either have a washout period of ≥8 weeks prior to Day 1 or ≥4 weeks prior to Day 1 if 11 days of standard cholestyramine therapy was completed
10. If taking NSAIDs, dose must be kept stable (defined as no change in prescription) for ≥2 weeks prior to Day 1
11. If taking oral corticosteroids, dose must be ≤10 mg / day of prednisone or equivalent, and be kept at a stable dose (defined as no change in prescription) for ≥4 weeks prior to Day 1
12. If using topical therapies for psoriasis (e.g. topical corticosteroids, coal tar, salicylic acid, vitamin D analogs, retinoids, anthralin, topical calcineurin inhibitors such as tacrolimus) dose must be stable (defined as no change in prescription) ≥2 weeks prior to Day 1
13. Meet one of the following TB Screening criteria:
a) No evidence of active or latent TB, which is defined as having ALL of the following:
i. A negative QuantiFERON® TB-Gold In-Tube test at Screening
AND
ii. A chest radiograph (views as per local guidelines) taken at Screening or within the 3 months prior to Screening (with the report or films available for investigator review) without evidence of active or latent TB infection
AND
iii. No history of either untreated or inadequately treated latent or active TB infection
b) For subjects with prior latent TB:
i. A completed course of therapy, as per local standard of care, for latent TB (9 months of isoniazid in a location where rates of primary multi-drug resistant TB infections are <5% or an acceptable alternative regimen) WITH a chest X-ray within 3 months prior to or at Screening
In these cases, no QuantiFERON® TB-Gold In-Tube test (or equivalent assay) need be obtained. A chest radiograph with the report or films must be available for investigator review.
NOTE: Cases falling under category “b” need to be approved in writing by the Sponsor or its designee prior to enrollment in the study. Subjects with currently ACTIVE TB are not allowed in the study, regardless of past or present anti-TB medication use. Subjects with a new diagnosis of latent TB during screening are not allowed in the study until completion of latent TB treatment is documented.
14. Able and willing to sign the informed consent as approved by IRB / IEC. Written consent must be provided before initiating any Screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments. Subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual.
15. Able and willing to perform SC self-injections or have a caregiver able, willing, and available to administer the injections
16. Subjects receiving non-prohibited medication for any reason should be on a stable dose (defined as no change in prescription and stable per investigator judgment) prior to the first administration of study drug on Day 1
17. A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy test result at the Day 1 Visit are required for female subjects of child bearing potential
18. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
19. Lactating females must agree to discontinue nursing before the study drug is administered
Exclusion Criteria
1. Known hypersensitivity to the study drug, the metabolites, or formulation excipients
2. Prior PsA or psoriasis treatment with a bioDMARD
3. Prior exposure to a JAK inhibitor >2 doses
4. Corticosteroid use as follows:
a) Intra-articular corticosteroids ≤8 weeks of Day 1
b) Parenteral corticosteroids ≤2 weeks of Day 1
5. Use of any of the following treatments ≤4 weeks of Day 1:
a) Intra-articular injection of hyaluronate therapies
b) Oral retinoids (including tazarotene)
c) Phototherapy (UVA or UVB) with or without psoralens or self-treatment with sunbathing or tanning beds
d) Potent P-glycoprotein (P-gp) inducers (e.g. carbamazepine, clotrimazole, cyclosporine, dexamethasone, phenothiazine, phenytoin, retinoic acid, rifampin, St. John’s wort and venlafaxine)
e) Oral or injectable gold
f) D-penicillamine
g) Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
6. Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgment of investigator
NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or an additional diagnosis of PsA
7. Any history of an inflammatory arthropathy with onset before age 16 years old
8. Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject by participating in the study, (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
9. Presence of any extra-articular manifestations typically associated with RA, such as rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of investigator
10. Have undergone surgical treatments for PsA, including synovectomy or arthroplasty in >4 joints and / or ≤12 weeks prior to Day 1
11. History of major surgery (requiring regional block or general anesthesia) ≤3 months prior to Screening or planned major surgery during the study
12. Administration of a live / attenuated vaccine ≤30 days prior to Day 1, or planned during the study
13. Participation in any clinical study of an investigational drug / device ≤4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics must be discussed with the Sponsor with written approval.
14. History of or current moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia, new or significant ECG finding at Screening, or any other cardiovascular condition which, in the opinion of the investigator, would put the subject at risk by participation in the study
15. History of malignancy ≤5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence)
16. History of lymphoproliferative disease or current lymphoproliferative disease
17. History of organ or bone marrow transplant
18. History of gastrointestinal perforation
19. Positive serology for human immunodeficiency virus (HIV) 1 or 2
20. Evidence of active HCV infection. Subjects with positive HCV Antibody (Ab) at Screening, require reflex testing for HCV RNA. Subjects with positive HCV RNA viral load (VL) at Screening will be excluded. Subjects with positive HCV Ab, but negative HCV RNA VL are eligible per investigator judgment, but require ongoing monitoring.
21. Evidence of active HBV infection. Subjects with positive HBV surface antigen (HBsAg) at Screening are excluded from the study. Subjects with positive HBV core Ab and negative HBsAg, require reflex testing for HBV DNA. Subjects with positive HBV DNA at Screening will be excluded. Subjects with positive HBV core Ab, and negative HBV DNA are eligible per investigator judgment, but may require prophylactic treatment in accordance with HBV treatment guidelines / local standard of care and require ongoing monitoring with blood tests for HBV DNA.
22. History of opportunistic infection, or immunodeficiency syndrome, which would put the subject at risk, as per investigator judgment
23. Active infection that is clinically significant, as per judgment of the investigator, or any infection requiring hospitalization or treatment with intravenous anti-infectives ≤60 days of Screening; or any infection requiring oral anti-infective therapy ≤2 weeks of Day 1
24. Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria)
25. History of disseminated staphylococcus aureus or disseminated herpes simplex infection
26. History of symptomatic herpes zoster infection ≤12 weeks prior to Screening or have history of disseminated / complicated herpes zoster infection (multi-dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
27. History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ
28. Current tobacco, alcohol, or substance abuse, per investigator judgement
29. Any known condition or contraindication as addressed in the local labeling for adalimumab that would preclude the subject from participating in this study
30. Active fibromyalgia or other disorder that based on the investigator’s opinion would make it difficult to appropriately assess PsA activity for the purposes of this study
31. Any chronic, uncontrolled medical condition, which would put the subject at increased risk during study participation including but not limited to: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurological and / or psychiatric disease or other disease of concern, or circumstances which may make a subject unlikely or unable to complete or comply with study procedures and requirements, as per investigator judgement
32. Ongoing suicidal ideation or history of suicide attempt ≤20 years of Screening
33. Significant blood loss (>450 mL) or transfusion of any blood product ≤12 weeks prior to Day 1
34. Central laboratory tests at Screening that meet any of the criteria below:
a) Hemoglobin <8.0g / dL (SI: <80 g / L)
b) White blood cells <3.0 x 103 cells / mm3(SI: <3.0 x 109 cells / L)
c) Neutrophils <1.5 x 103 cells / mm3(SI: <1.5 x 109 cells / L)
d) Lymphocytes <0.5 x 103 cells / mm3(SI: <0.5 x 109 cells / L)
e) Platelets <100 x 103 cells / mm3(SI: <100 x 109 cells / L)
f) ALT or AST ≥1.5x ULN
g) Total bilirubin level ≥2x ULN unless the subject has been diagnosed with Gilbert’s disease and this is clearly documented
h) Estimated creatinine clearance <40 mL/min based on the Cockroft Gault formula
NOTE: Before subject is considered a screen-failure, out of range lab values may be rechecked one time after consultation with the Sponsor or designee. Written approval must be obtained.
35. Subject is unwilling or unable to follow protocol requirements
2. Prior PsA or psoriasis treatment with a bioDMARD
3. Prior exposure to a JAK inhibitor >2 doses
4. Corticosteroid use as follows:
a) Intra-articular corticosteroids ≤8 weeks of Day 1
b) Parenteral corticosteroids ≤2 weeks of Day 1
5. Use of any of the following treatments ≤4 weeks of Day 1:
a) Intra-articular injection of hyaluronate therapies
b) Oral retinoids (including tazarotene)
c) Phototherapy (UVA or UVB) with or without psoralens or self-treatment with sunbathing or tanning beds
d) Potent P-glycoprotein (P-gp) inducers (e.g. carbamazepine, clotrimazole, cyclosporine, dexamethasone, phenothiazine, phenytoin, retinoic acid, rifampin, St. John’s wort and venlafaxine)
e) Oral or injectable gold
f) D-penicillamine
g) Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
6. Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgment of investigator
NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or an additional diagnosis of PsA
7. Any history of an inflammatory arthropathy with onset before age 16 years old
8. Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject by participating in the study, (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
9. Presence of any extra-articular manifestations typically associated with RA, such as rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of investigator
10. Have undergone surgical treatments for PsA, including synovectomy or arthroplasty in >4 joints and / or ≤12 weeks prior to Day 1
11. History of major surgery (requiring regional block or general anesthesia) ≤3 months prior to Screening or planned major surgery during the study
12. Administration of a live / attenuated vaccine ≤30 days prior to Day 1, or planned during the study
13. Participation in any clinical study of an investigational drug / device ≤4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics must be discussed with the Sponsor with written approval.
14. History of or current moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia, new or significant ECG finding at Screening, or any other cardiovascular condition which, in the opinion of the investigator, would put the subject at risk by participation in the study
15. History of malignancy ≤5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence)
16. History of lymphoproliferative disease or current lymphoproliferative disease
17. History of organ or bone marrow transplant
18. History of gastrointestinal perforation
19. Positive serology for human immunodeficiency virus (HIV) 1 or 2
20. Evidence of active HCV infection. Subjects with positive HCV Antibody (Ab) at Screening, require reflex testing for HCV RNA. Subjects with positive HCV RNA viral load (VL) at Screening will be excluded. Subjects with positive HCV Ab, but negative HCV RNA VL are eligible per investigator judgment, but require ongoing monitoring.
21. Evidence of active HBV infection. Subjects with positive HBV surface antigen (HBsAg) at Screening are excluded from the study. Subjects with positive HBV core Ab and negative HBsAg, require reflex testing for HBV DNA. Subjects with positive HBV DNA at Screening will be excluded. Subjects with positive HBV core Ab, and negative HBV DNA are eligible per investigator judgment, but may require prophylactic treatment in accordance with HBV treatment guidelines / local standard of care and require ongoing monitoring with blood tests for HBV DNA.
22. History of opportunistic infection, or immunodeficiency syndrome, which would put the subject at risk, as per investigator judgment
23. Active infection that is clinically significant, as per judgment of the investigator, or any infection requiring hospitalization or treatment with intravenous anti-infectives ≤60 days of Screening; or any infection requiring oral anti-infective therapy ≤2 weeks of Day 1
24. Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria)
25. History of disseminated staphylococcus aureus or disseminated herpes simplex infection
26. History of symptomatic herpes zoster infection ≤12 weeks prior to Screening or have history of disseminated / complicated herpes zoster infection (multi-dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
27. History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ
28. Current tobacco, alcohol, or substance abuse, per investigator judgement
29. Any known condition or contraindication as addressed in the local labeling for adalimumab that would preclude the subject from participating in this study
30. Active fibromyalgia or other disorder that based on the investigator’s opinion would make it difficult to appropriately assess PsA activity for the purposes of this study
31. Any chronic, uncontrolled medical condition, which would put the subject at increased risk during study participation including but not limited to: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurological and / or psychiatric disease or other disease of concern, or circumstances which may make a subject unlikely or unable to complete or comply with study procedures and requirements, as per investigator judgement
32. Ongoing suicidal ideation or history of suicide attempt ≤20 years of Screening
33. Significant blood loss (>450 mL) or transfusion of any blood product ≤12 weeks prior to Day 1
34. Central laboratory tests at Screening that meet any of the criteria below:
a) Hemoglobin <8.0g / dL (SI: <80 g / L)
b) White blood cells <3.0 x 103 cells / mm3(SI: <3.0 x 109 cells / L)
c) Neutrophils <1.5 x 103 cells / mm3(SI: <1.5 x 109 cells / L)
d) Lymphocytes <0.5 x 103 cells / mm3(SI: <0.5 x 109 cells / L)
e) Platelets <100 x 103 cells / mm3(SI: <100 x 109 cells / L)
f) ALT or AST ≥1.5x ULN
g) Total bilirubin level ≥2x ULN unless the subject has been diagnosed with Gilbert’s disease and this is clearly documented
h) Estimated creatinine clearance <40 mL/min based on the Cockroft Gault formula
NOTE: Before subject is considered a screen-failure, out of range lab values may be rechecked one time after consultation with the Sponsor or designee. Written approval must be obtained.
35. Subject is unwilling or unable to follow protocol requirements
The Estimated Number of Participants
-
Taiwan
0 participants
-
Global
67 participants
