Clinical Trials List
Protocol NumberCNTO1275AKS3002
2015-09-01 - 2019-12-31
Phase III
Terminated10
ICD-10M32.14
Glomerular disease in systemic lupus erythematosus
ICD-10M46.90
Unspecified inflammatory spondylopathy, site unspecified
ICD-10M47
Spondylosis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Refractory Subjects With Active Radiographic Axial Spondyloarthritis
-
Trial Applicant
Johnson & Johnson
-
Sponsor
Janssen Research & Development
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 劉明煇 Division of Rheumatology
- Chia-Tse Weng Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chang-Fu Kuo Division of Rheumatology
- TianMing Zhan Division of Rheumatology
- Yao-Fan Fang Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蔡嘉哲 風濕免疫科
- 黃建中 風濕免疫科
- Chung-Ming Huang 風濕免疫科
- 洪偉哲 風濕免疫科
- Po-Hao Huang 風濕免疫科
- Jiunn-Horng Chen 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 田雅之 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Active Radiographic Axial Spondyloarthritis
Objectives
Primary Objective
The primary objective of this study is to assess the efficacy of ustekinumab, in adult anti-TNFα refractory
subjects with active radiographic AxSpA, as measured by the reduction in signs and symptoms of
radiographic AxSpA.
Secondary Objectives
The secondary objectives are to assess the effect of treatment with ustekinumab in anti-TNFα refractory
subjects with active radiographic AxSpA on the following:
Efficacy related to improving physical function, range of motion, health-related quality of life, and
other health outcomes.
Safety.
Pharmacokinetics (PK) and immunogenicity
Test Drug
STELARA
Active Ingredient
Ustekinumab
Dosage Form
Pre-filled syringe
Pre-filled syringe
Pre-filled syringe
Dosage
45mg
90mg
90mg
Endpoints
Primary Endpoint
The primary endpoint is the proportion of subjects achieving an ASAS 40 response at Week 24.
Major Secondary Endpoints
The following major secondary analyses will be performed. The major secondary endpoints are listed in
order of importance as specified below:
1. The proportion of subjects who achieve an ASAS 20 at Week 24.
2. The proportion of subjects who achieve at least 50% improvement from baseline in BASDAI at Week 24.
3. The change from baseline in BASFI at Week 24.
4. The proportion of subjects who achieve ASDAS (CRP) inactive disease (<1.3) at Week 24.
The primary endpoint is the proportion of subjects achieving an ASAS 40 response at Week 24.
Major Secondary Endpoints
The following major secondary analyses will be performed. The major secondary endpoints are listed in
order of importance as specified below:
1. The proportion of subjects who achieve an ASAS 20 at Week 24.
2. The proportion of subjects who achieve at least 50% improvement from baseline in BASDAI at Week 24.
3. The change from baseline in BASFI at Week 24.
4. The proportion of subjects who achieve ASDAS (CRP) inactive disease (<1.3) at Week 24.
Inclution Criteria
Each potential radiographic AxSpA subject must satisfy all of the following criteria to be
enrolled in the study.
1. Subjects must be 18 years of age or older (or of legal age of consent in the country
if older than 18 years)
2. Subjects must have a diagnosis of definite AS, as defined by the modified 1984
New York criteria.53 The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met:
a. Radiographic criterion: Sacroiliitis Grade ≥ 2 bilaterally or sacroiliitis
Grade 3 to 4 unilaterally.
b. Clinical criteria (at least 1):
1) Low back pain and stiffness for more than 3 months, which improves
with exercise, but is not relieved by rest.
2) Limitation of motion of the lumbar spine in both the sagittal and
frontal planes.
3) Limitation of chest expansion relative to normal values corrected for
age and sex.
3. Subjects must have symptoms of active disease at screening and at baseline, as
evidenced by both a BASDAI score of 4 and a VAS score for total back pain of
4, each on a scale of 0 to 10.
4. Have an elevated hsCRP level of 0.300 mg/dL at screening.
NOTE: A one-time repeat assessment of hsCRP level is allowed during the 8-
week screening period and the Investigator may consider the subject eligible if
the test result is within acceptable range on repeat testing in the central
laboratory.
5. Refractory to no more than 1 anti-TNFα therapy by either of the following 2
reasons:
Lack of benefit from anti-TNFα therapy, as assessed by the treating physician,
after at least 12 weeks of infliximab (Remicade®
, Remsima®
, Inflectra®
,
Infimab®
), certolizumab pegol, etanercept, (Enbrel®
, YiSaiPu®
, Etanar®)
, or
adalimumab (Humira®, Exemptia®
). Documented lack of benefit may include
inadequate improvement in disease activity.
Received infliximab (Remicade®
, Remsima®
, Inflectra®
, Infimab®
),
certolizumab pegol, etanercept (Enbrel®
, YiSaiPu®
, Etanar®
), or adalimumab
(Humira®
, Exemptia®
) and have documented intolerance to anti-TNFα
therapy (eg, infusion/injection site reaction, or other AE(s) that precludes
continuation of that anti-TNFα agent).
6. Has an inadequate response to at least 2 NSAIDs over a 4-week period in total with
maximal recommended doses of NSAID(s), or is unable to receive a full 4 weeks of
maximal NSAID therapy because of intolerance, toxicity, or contraindications to
NSAIDs.
7. If using NSAIDs or other analgesics for AS, must be on a stable dose for at least
2 weeks prior to the first administration of study agent. If currently not using
NSAIDs or other analgesics for AS, must not have received NSAIDs or other
analgesics for AS for at least 2 weeks prior to the first administration of the study
agent.
8. If using oral corticosteroids, must be on a stable dose equivalent to 10 mg of
prednisone/day for at least 2 weeks prior to the first administration of study agent.
If currently not using corticosteroids, must have not received oral corticosteroids
for at least 2 weeks prior to the first administration of the study agent.
9. If using methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ),
should have started treatment at least 3 months prior to the first administration of
study agent and should have no serious toxic side effects attributable to those
DMARDs. MTX routes of administration and doses (not to exceed 25 mg/week)
should be stable for at least 4 weeks prior to the first administration of the study
agent. If using SSZ or HCQ, must also be on a stable dose for at least 4 weeks prior
to the first administration of study agent. If currently not using MTX, SSZ, or
HCQ, must have not received these DMARDs for at least 4 weeks prior to the first
administration of the study agent.
10. Subjects with complete ankylosis of the spine, defined as bridging syndesmophytes
present at all intervertebral levels of the cervical and lumbar spine visualized on
lateral-view spinal radiographs are permitted to be included in the study, but will be
limited to approximately 10% of the study population.
11. Before randomization, a woman must be either:
Not of childbearing potential: premenarchal; postmenopausal (>45 years of
age with amenorrhea for at least 12 months); permanently sterilized (eg, tubal
occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable
of pregnancy,
Of childbearing potential and practicing a highly effective method of birth
control consistent with local regulations regarding the use of birth control
methods for subjects participating in clinical studies: eg, established use of
oral, injected or implanted hormonal methods of contraception associated with
inhibition of ovulation; placement of an intrauterine device (IUD) or
intrauterine system (IUS); male partner sterilization (the vasectomized partner
should be the sole partner for that subject); true abstinence (when this is in
line with the preferred and usual lifestyle of the subject).
Note: If the childbearing potential changes after start of the study (eg, woman
who is not heterosexually active becomes active, premenarchal woman
experiences menarche) a woman must begin a highly effective method of
birth control, as described above.
12. A woman of childbearing potential must have a negative serum (-human chorionic
gonadotropin [-hCG]) at screening and a negative urine pregnancy test at Week 0
before randomization.
13. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for 5 months after receiving the last dose of
study agent.
14. A man who is sexually active with a woman of childbearing potential and has not
had a vasectomy must agree to use a barrier method of birth control eg, either
condom with spermicidal foam/gel/film/cream/suppository or partner with
occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository, and all men must also not donate sperm during
the study and for 5 months after receiving the last dose of study agent.
15. Are considered eligible according to the following tuberculosis (TB) screening
criteria:
a. Have no history of latent or active TB prior to screening. An
exception is made for subjects who have a history of latent TB and
are currently receiving treatment for latent TB, will initiate treatment
for latent TB prior to first administration of study agent, or have
documentation of having completed appropriate treatment for latent
TB within 5 years prior to the first administration of study agent. It
is the responsibility of the investigator to verify the adequacy of
previous anti-tuberculous treatment and provide appropriate
documentation.
b. Have no signs or symptoms suggestive of active TB upon medical
history and/or physical examination.
c. Have had no recent close contact with a person with active TB or, if
there has been such contact, will be referred to a physician
specializing in TB to undergo additional evaluation and, if
warranted, receive appropriate treatment for latent TB prior to the
first administration of study agent.
d. Within 8 weeks prior to the first administration of study agent, have
a negative QuantiFERON®
-TB Gold test result (Appendix A), or
have a newly identified positive QuantiFERON®
-TB Gold test result
in which active TB has been ruled out and for which appropriate
treatment for latent TB has been initiated prior to the first
administration of study agent. Within 8 weeks prior to the first
administration of study agent, a negative tuberculin skin test (TST; ), or a newly identified positive TST in which active TB
has been ruled out and for which appropriate treatment for latent TB
has been initiated prior to the first administration of study agent, is
additionally required if the QuantiFERON®
-TB Gold test is not
approved/registered in that country or the TST is mandated by local
health authorities.
- Subjects with 2 indeterminate QuantiFERON®
-TB Gold test
results may be enrolled without treatment for latent TB, if active
TB is ruled out, their chest radiograph shows no abnormality
suggestive of TB (active or old, inactive TB), and the subject has
no additional risk factors for TB as determined by the
investigator. This determination must be promptly reported to
the Sponsor’s medical monitor and recorded in the subject's
source documents and initialed by the investigator.
e. The QuantiFERON®-TB Gold test and the TST are not required at
screening for subjects with a history of latent TB and ongoing
treatment for latent TB or documentation of having completed
adequate treatment as described above; Subjects with documentation
of having completed adequate treatment as described above are not
required to initiate additional treatment for latent TB.
f. Have a chest radiograph (both posterior-anterior and lateral views or
per country regulations where applicable) taken within 3 months
prior to the first administration of study agent and read by a
qualified radiologist, with no evidence of current, active TB or old,
inactive TB.
16. Have screening laboratory test results within the following parameters:
a. Hemoglobin 8.5 g/dL (SI: 85 g/L)
b. White blood cells 3.5 x 103
/L (SI: 3.5 GI/L)
c. Neutrophils 1.5 x 103
/L (SI: 1.5 GI/L)
d. Platelets 100 x 103
/L (SI: 100 GI/L)
e. Serum creatinine 1.5 mg/dL (SI: 129 mol/L)
f. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and
alkaline phosphatase levels must be within 1.5 times the upper limit of
normal (ULN) range for the laboratory conducting the test.
NOTE: A one-time repeat of these screening laboratory tests is allowed during the
8-week screening period and the Investigator may consider the subject eligible if
the previously abnormal laboratory test result is within acceptable range on repeat
testing in the central laboratory.
17. Subject must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol.
18. Be able to read, write, understand, and complete study questionnaires.
19. Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study.
20. Each subject must sign a separate informed consent form if he or she agrees to
provide an optional DNA sample for research (where local regulations permit).
Refusal to give consent for the optional DNA research sample does not exclude a
subject from participation in the study.
21. Are willing to refrain from the use of complementary therapies including ayurvedic
medicine, traditional Chinese medication(s), and acupuncture within 2 weeks prior
to the first study agent administration and throughout the duration of the study.
enrolled in the study.
1. Subjects must be 18 years of age or older (or of legal age of consent in the country
if older than 18 years)
2. Subjects must have a diagnosis of definite AS, as defined by the modified 1984
New York criteria.53 The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met:
a. Radiographic criterion: Sacroiliitis Grade ≥ 2 bilaterally or sacroiliitis
Grade 3 to 4 unilaterally.
b. Clinical criteria (at least 1):
1) Low back pain and stiffness for more than 3 months, which improves
with exercise, but is not relieved by rest.
2) Limitation of motion of the lumbar spine in both the sagittal and
frontal planes.
3) Limitation of chest expansion relative to normal values corrected for
age and sex.
3. Subjects must have symptoms of active disease at screening and at baseline, as
evidenced by both a BASDAI score of 4 and a VAS score for total back pain of
4, each on a scale of 0 to 10.
4. Have an elevated hsCRP level of 0.300 mg/dL at screening.
NOTE: A one-time repeat assessment of hsCRP level is allowed during the 8-
week screening period and the Investigator may consider the subject eligible if
the test result is within acceptable range on repeat testing in the central
laboratory.
5. Refractory to no more than 1 anti-TNFα therapy by either of the following 2
reasons:
Lack of benefit from anti-TNFα therapy, as assessed by the treating physician,
after at least 12 weeks of infliximab (Remicade®
, Remsima®
, Inflectra®
,
Infimab®
), certolizumab pegol, etanercept, (Enbrel®
, YiSaiPu®
, Etanar®)
, or
adalimumab (Humira®, Exemptia®
). Documented lack of benefit may include
inadequate improvement in disease activity.
Received infliximab (Remicade®
, Remsima®
, Inflectra®
, Infimab®
),
certolizumab pegol, etanercept (Enbrel®
, YiSaiPu®
, Etanar®
), or adalimumab
(Humira®
, Exemptia®
) and have documented intolerance to anti-TNFα
therapy (eg, infusion/injection site reaction, or other AE(s) that precludes
continuation of that anti-TNFα agent).
6. Has an inadequate response to at least 2 NSAIDs over a 4-week period in total with
maximal recommended doses of NSAID(s), or is unable to receive a full 4 weeks of
maximal NSAID therapy because of intolerance, toxicity, or contraindications to
NSAIDs.
7. If using NSAIDs or other analgesics for AS, must be on a stable dose for at least
2 weeks prior to the first administration of study agent. If currently not using
NSAIDs or other analgesics for AS, must not have received NSAIDs or other
analgesics for AS for at least 2 weeks prior to the first administration of the study
agent.
8. If using oral corticosteroids, must be on a stable dose equivalent to 10 mg of
prednisone/day for at least 2 weeks prior to the first administration of study agent.
If currently not using corticosteroids, must have not received oral corticosteroids
for at least 2 weeks prior to the first administration of the study agent.
9. If using methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ),
should have started treatment at least 3 months prior to the first administration of
study agent and should have no serious toxic side effects attributable to those
DMARDs. MTX routes of administration and doses (not to exceed 25 mg/week)
should be stable for at least 4 weeks prior to the first administration of the study
agent. If using SSZ or HCQ, must also be on a stable dose for at least 4 weeks prior
to the first administration of study agent. If currently not using MTX, SSZ, or
HCQ, must have not received these DMARDs for at least 4 weeks prior to the first
administration of the study agent.
10. Subjects with complete ankylosis of the spine, defined as bridging syndesmophytes
present at all intervertebral levels of the cervical and lumbar spine visualized on
lateral-view spinal radiographs are permitted to be included in the study, but will be
limited to approximately 10% of the study population.
11. Before randomization, a woman must be either:
Not of childbearing potential: premenarchal; postmenopausal (>45 years of
age with amenorrhea for at least 12 months); permanently sterilized (eg, tubal
occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable
of pregnancy,
Of childbearing potential and practicing a highly effective method of birth
control consistent with local regulations regarding the use of birth control
methods for subjects participating in clinical studies: eg, established use of
oral, injected or implanted hormonal methods of contraception associated with
inhibition of ovulation; placement of an intrauterine device (IUD) or
intrauterine system (IUS); male partner sterilization (the vasectomized partner
should be the sole partner for that subject); true abstinence (when this is in
line with the preferred and usual lifestyle of the subject).
Note: If the childbearing potential changes after start of the study (eg, woman
who is not heterosexually active becomes active, premenarchal woman
experiences menarche) a woman must begin a highly effective method of
birth control, as described above.
12. A woman of childbearing potential must have a negative serum (-human chorionic
gonadotropin [-hCG]) at screening and a negative urine pregnancy test at Week 0
before randomization.
13. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for 5 months after receiving the last dose of
study agent.
14. A man who is sexually active with a woman of childbearing potential and has not
had a vasectomy must agree to use a barrier method of birth control eg, either
condom with spermicidal foam/gel/film/cream/suppository or partner with
occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository, and all men must also not donate sperm during
the study and for 5 months after receiving the last dose of study agent.
15. Are considered eligible according to the following tuberculosis (TB) screening
criteria:
a. Have no history of latent or active TB prior to screening. An
exception is made for subjects who have a history of latent TB and
are currently receiving treatment for latent TB, will initiate treatment
for latent TB prior to first administration of study agent, or have
documentation of having completed appropriate treatment for latent
TB within 5 years prior to the first administration of study agent. It
is the responsibility of the investigator to verify the adequacy of
previous anti-tuberculous treatment and provide appropriate
documentation.
b. Have no signs or symptoms suggestive of active TB upon medical
history and/or physical examination.
c. Have had no recent close contact with a person with active TB or, if
there has been such contact, will be referred to a physician
specializing in TB to undergo additional evaluation and, if
warranted, receive appropriate treatment for latent TB prior to the
first administration of study agent.
d. Within 8 weeks prior to the first administration of study agent, have
a negative QuantiFERON®
-TB Gold test result (Appendix A), or
have a newly identified positive QuantiFERON®
-TB Gold test result
in which active TB has been ruled out and for which appropriate
treatment for latent TB has been initiated prior to the first
administration of study agent. Within 8 weeks prior to the first
administration of study agent, a negative tuberculin skin test (TST; ), or a newly identified positive TST in which active TB
has been ruled out and for which appropriate treatment for latent TB
has been initiated prior to the first administration of study agent, is
additionally required if the QuantiFERON®
-TB Gold test is not
approved/registered in that country or the TST is mandated by local
health authorities.
- Subjects with 2 indeterminate QuantiFERON®
-TB Gold test
results may be enrolled without treatment for latent TB, if active
TB is ruled out, their chest radiograph shows no abnormality
suggestive of TB (active or old, inactive TB), and the subject has
no additional risk factors for TB as determined by the
investigator. This determination must be promptly reported to
the Sponsor’s medical monitor and recorded in the subject's
source documents and initialed by the investigator.
e. The QuantiFERON®-TB Gold test and the TST are not required at
screening for subjects with a history of latent TB and ongoing
treatment for latent TB or documentation of having completed
adequate treatment as described above; Subjects with documentation
of having completed adequate treatment as described above are not
required to initiate additional treatment for latent TB.
f. Have a chest radiograph (both posterior-anterior and lateral views or
per country regulations where applicable) taken within 3 months
prior to the first administration of study agent and read by a
qualified radiologist, with no evidence of current, active TB or old,
inactive TB.
16. Have screening laboratory test results within the following parameters:
a. Hemoglobin 8.5 g/dL (SI: 85 g/L)
b. White blood cells 3.5 x 103
/L (SI: 3.5 GI/L)
c. Neutrophils 1.5 x 103
/L (SI: 1.5 GI/L)
d. Platelets 100 x 103
/L (SI: 100 GI/L)
e. Serum creatinine 1.5 mg/dL (SI: 129 mol/L)
f. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and
alkaline phosphatase levels must be within 1.5 times the upper limit of
normal (ULN) range for the laboratory conducting the test.
NOTE: A one-time repeat of these screening laboratory tests is allowed during the
8-week screening period and the Investigator may consider the subject eligible if
the previously abnormal laboratory test result is within acceptable range on repeat
testing in the central laboratory.
17. Subject must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol.
18. Be able to read, write, understand, and complete study questionnaires.
19. Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study.
20. Each subject must sign a separate informed consent form if he or she agrees to
provide an optional DNA sample for research (where local regulations permit).
Refusal to give consent for the optional DNA research sample does not exclude a
subject from participation in the study.
21. Are willing to refrain from the use of complementary therapies including ayurvedic
medicine, traditional Chinese medication(s), and acupuncture within 2 weeks prior
to the first study agent administration and throughout the duration of the study.
Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating
in the study.
1. Have other inflammatory diseases that might confound the evaluations of benefit from
the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic
lupus erythematosus, or Lyme disease.
2. Has received infliximab or infliximab biosimilar, within 12 weeks of the first
study agent administration.
Has received adalimumab, adalimumab biosimilar, or certolizumab pegol within
6 weeks of the first study agent administration.
Has received etanercept or etanercept biosimilar within 6 weeks of the first study
agent administration.
3. Has ever received golimumab
4. Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the
study or within 5 months after receiving the last administration of study agent.
5. Have received any systemic immunosuppressives or DMARDs other than MTX, SSZ,
or HCQ within 4 weeks prior to first administration of study agent. Medications in these
categories include, but are not limited to chloroquine, azathioprine, cyclosporine,
mycophenolate mofetil, gold, and penicillamine. Corticosteroids are not included in this
criterion; see other eligibility criteria regarding corticosteroids.
6. Have received leflunomide within 3 months prior to the first administration of study
agent (irrespective of undergoing a drug elimination procedure), or have received
leflunomide within 12 months prior to the first administration of study agent and have
not undergone a drug elimination procedure.
7. Have received epidural, intra-articular, IM, or IV corticosteroids, including
adrenocorticotropic hormone during the 4 weeks prior to first administration of study
agent.
8. Have received any prior biologic therapy other than TNFα inhibitors, including, but not
limited to ustekinumab, tocilizumab, alefacept, efalizumab, natalizumab, abatacept,
anakinra, brodalumab, secukinumab, ixekizumab, and B-cell depleting therapies.
9. Have ever received tofacitinib or any other Janus kinase (JAK) inhibitor.
10. Have total spinal ankylosis.
11. Have a known hypersensitivity to human immunoglobulin proteins.
12. Have used cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen
mustard, or other alkylating agents.
13. Have a history of active granulomatous infection, including histoplasmosis, or
coccidioidomycosis, prior to screening. Refer to inclusion criterion #15 for information
regarding eligibility with a history of latent TB.
14. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
15. Have a chest radiograph within 3 months prior to the first administration of study agent
that shows an abnormality suggestive of a malignancy or current active infection,
including TB.
16. Have had a nontuberculous mycobacterial infection or opportunistic infection
(eg, cytomegalovirus, pneumocystosis, aspergillosis).
17. Have received, or are expected to receive, any live virus or bacterial vaccination within
3 months before the first administration of study agent, during the study, or within
3 months after the last administration of study agent. For BCG vaccination criterion,
refer to Exclusion Criterion #14.
18. Have a history of an infected joint prosthesis, or have received antibiotics for a
suspected infection of a joint prosthesis, if that prosthesis has not been removed or
replaced.
19. Have had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis,
or pyelonephritis), or have been hospitalized for an infection, or have been treated with
intravenous antibiotics for an infection within 2 months prior to first administration of
study agent. Less serious infections (eg, acute upper respiratory tract infection, simple
urinary tract infection) need not be considered exclusionary at the discretion of the
investigator.
20. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not
limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis,
recurrent urinary tract infection (eg, recurrent pyelonephritis), an open, draining, or
infected skin wound or ulcer.
21. Subject has a history of human immunodeficiency virus (HIV) antibody positive, or
tests positive for HIV at Screening.
22. Has a hepatitis B infection. Subjects must undergo screening for hepatitis B virus
(HBV; Appendix C). At a minimum, this includes testing for HBsAg (HBV surface
antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core antibody
total).
23. Subjects who are seropositive for antibodies to hepatitis C virus (HCV), unless they
have 2 negative HCV RNA test results 6 months apart prior to screening and have a
third negative HCV RNA test result at screening.
24. Have a history of known demyelinating diseases such as multiple sclerosis or optic
neuritis (contraindication for the use of anti-TNFα agent as rescue therapy).
25. Has a diagnosis of congestive heart failure Class III or IV.
26. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or
psychiatric disease.
27. Have a known history of lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
of unusual size or location, clinically significant splenomegaly, or history of monoclonal
gammopathy of undetermined significance.
28. Subject has a history of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin that have been treated with no evidence
of recurrence for at least 3 months before the first study agent administration and
carcinoma in situ of the cervix that has been surgically cured).
29. Subject has known allergies, hypersensitivity, or intolerance to ustekinumab or its
excipients and/or golimumab or its excipients (refer to the ustekinumab Investigator’s
Brochure and the golimumab Investigator’s Brochure).
30. Are currently receiving venom immunotherapy (honeybee, wasp, yellow jacket, hornet,
or fire ant).
31. Subject has taken any disallowed therapies as noted in Section 8, before the planned
first dose of study agent.
32. Subject has received an investigational drug (including investigational vaccines) within
5 half-lives or 3 months, whichever is longer, or used an invasive investigational
medical device within 3 months before the planned first dose of study agent or is
currently enrolled in an investigational study.
33. Subject has any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject (eg, compromise the well-being) or that
could prevent, limit, or confound the protocol-specified assessments.
34. Subject has had major surgery, (eg, requiring general anesthesia) within 1 month before
screening, or will not have fully recovered from surgery, or has surgery planned during
the time the subject is expected to participate in the study or within 1 month after the
last dose of study agent administration.
Note: subjects with planned surgical procedures to be conducted under local
anesthesia may participate
35. Have a transplanted organ (with the exception of a corneal transplant performed
>3 months prior to first administration of study agent).
36. Have or have had a substance abuse (drug or alcohol) problem within the previous 3
years.
37. Are unwilling or unable to undergo multiple venipunctures because of poor tolerability
or lack of easy access.
38. Subject is an employee of the investigator or study site, with direct involvement in the
proposed study or other studies under the direction of that investigator or study site, as
well as family members of the employees or the investigator.
in the study.
1. Have other inflammatory diseases that might confound the evaluations of benefit from
the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic
lupus erythematosus, or Lyme disease.
2. Has received infliximab or infliximab biosimilar, within 12 weeks of the first
study agent administration.
Has received adalimumab, adalimumab biosimilar, or certolizumab pegol within
6 weeks of the first study agent administration.
Has received etanercept or etanercept biosimilar within 6 weeks of the first study
agent administration.
3. Has ever received golimumab
4. Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the
study or within 5 months after receiving the last administration of study agent.
5. Have received any systemic immunosuppressives or DMARDs other than MTX, SSZ,
or HCQ within 4 weeks prior to first administration of study agent. Medications in these
categories include, but are not limited to chloroquine, azathioprine, cyclosporine,
mycophenolate mofetil, gold, and penicillamine. Corticosteroids are not included in this
criterion; see other eligibility criteria regarding corticosteroids.
6. Have received leflunomide within 3 months prior to the first administration of study
agent (irrespective of undergoing a drug elimination procedure), or have received
leflunomide within 12 months prior to the first administration of study agent and have
not undergone a drug elimination procedure.
7. Have received epidural, intra-articular, IM, or IV corticosteroids, including
adrenocorticotropic hormone during the 4 weeks prior to first administration of study
agent.
8. Have received any prior biologic therapy other than TNFα inhibitors, including, but not
limited to ustekinumab, tocilizumab, alefacept, efalizumab, natalizumab, abatacept,
anakinra, brodalumab, secukinumab, ixekizumab, and B-cell depleting therapies.
9. Have ever received tofacitinib or any other Janus kinase (JAK) inhibitor.
10. Have total spinal ankylosis.
11. Have a known hypersensitivity to human immunoglobulin proteins.
12. Have used cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen
mustard, or other alkylating agents.
13. Have a history of active granulomatous infection, including histoplasmosis, or
coccidioidomycosis, prior to screening. Refer to inclusion criterion #15 for information
regarding eligibility with a history of latent TB.
14. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
15. Have a chest radiograph within 3 months prior to the first administration of study agent
that shows an abnormality suggestive of a malignancy or current active infection,
including TB.
16. Have had a nontuberculous mycobacterial infection or opportunistic infection
(eg, cytomegalovirus, pneumocystosis, aspergillosis).
17. Have received, or are expected to receive, any live virus or bacterial vaccination within
3 months before the first administration of study agent, during the study, or within
3 months after the last administration of study agent. For BCG vaccination criterion,
refer to Exclusion Criterion #14.
18. Have a history of an infected joint prosthesis, or have received antibiotics for a
suspected infection of a joint prosthesis, if that prosthesis has not been removed or
replaced.
19. Have had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis,
or pyelonephritis), or have been hospitalized for an infection, or have been treated with
intravenous antibiotics for an infection within 2 months prior to first administration of
study agent. Less serious infections (eg, acute upper respiratory tract infection, simple
urinary tract infection) need not be considered exclusionary at the discretion of the
investigator.
20. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not
limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis,
recurrent urinary tract infection (eg, recurrent pyelonephritis), an open, draining, or
infected skin wound or ulcer.
21. Subject has a history of human immunodeficiency virus (HIV) antibody positive, or
tests positive for HIV at Screening.
22. Has a hepatitis B infection. Subjects must undergo screening for hepatitis B virus
(HBV; Appendix C). At a minimum, this includes testing for HBsAg (HBV surface
antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core antibody
total).
23. Subjects who are seropositive for antibodies to hepatitis C virus (HCV), unless they
have 2 negative HCV RNA test results 6 months apart prior to screening and have a
third negative HCV RNA test result at screening.
24. Have a history of known demyelinating diseases such as multiple sclerosis or optic
neuritis (contraindication for the use of anti-TNFα agent as rescue therapy).
25. Has a diagnosis of congestive heart failure Class III or IV.
26. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or
psychiatric disease.
27. Have a known history of lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
of unusual size or location, clinically significant splenomegaly, or history of monoclonal
gammopathy of undetermined significance.
28. Subject has a history of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin that have been treated with no evidence
of recurrence for at least 3 months before the first study agent administration and
carcinoma in situ of the cervix that has been surgically cured).
29. Subject has known allergies, hypersensitivity, or intolerance to ustekinumab or its
excipients and/or golimumab or its excipients (refer to the ustekinumab Investigator’s
Brochure and the golimumab Investigator’s Brochure).
30. Are currently receiving venom immunotherapy (honeybee, wasp, yellow jacket, hornet,
or fire ant).
31. Subject has taken any disallowed therapies as noted in Section 8, before the planned
first dose of study agent.
32. Subject has received an investigational drug (including investigational vaccines) within
5 half-lives or 3 months, whichever is longer, or used an invasive investigational
medical device within 3 months before the planned first dose of study agent or is
currently enrolled in an investigational study.
33. Subject has any condition for which, in the opinion of the investigator, participation
would not be in the best interest of the subject (eg, compromise the well-being) or that
could prevent, limit, or confound the protocol-specified assessments.
34. Subject has had major surgery, (eg, requiring general anesthesia) within 1 month before
screening, or will not have fully recovered from surgery, or has surgery planned during
the time the subject is expected to participate in the study or within 1 month after the
last dose of study agent administration.
Note: subjects with planned surgical procedures to be conducted under local
anesthesia may participate
35. Have a transplanted organ (with the exception of a corneal transplant performed
>3 months prior to first administration of study agent).
36. Have or have had a substance abuse (drug or alcohol) problem within the previous 3
years.
37. Are unwilling or unable to undergo multiple venipunctures because of poor tolerability
or lack of easy access.
38. Subject is an employee of the investigator or study site, with direct involvement in the
proposed study or other studies under the direction of that investigator or study site, as
well as family members of the employees or the investigator.
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
483 participants
