| Eligibility |
Inclusion Criteria:
Male and female patients aged =18 years at the time of signing the Informed Consent Form.
Subjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic
Arthritis (CASPAR) criteria (Appendix 4) confirmed less than 24 months prior to screening.
Subjects with active PsA defined as the presence of at least 3/68 tender and at least 3/66
swollen joints or 2 swollen and 2 tender joints plus one affected entheseal site (Achilles
tendon and/or plantar fascia) at baseline.
Are treatment naïve to DMARDs. Are capable of understanding and signing an informed consent
form. Women of childbearing potential or men capable of fathering children must be using
adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device,
barrier method with spermicide, surgical sterilization) during the study and for 6 months
after receiving the last administration of study agent. Female subjects of childbearing
potential must test negative for pregnancy. Female subjects must agree to not donate eggs
(ova, oocytes) during the study and for 6 months after last dose of study agent. Male
subjects must agree to not donate sperm while in the study and for 6 months after last dose
of study agent.
Patients fulfilling the following TB criteria:
7.1. Have no history of latent or active TB prior to screening. An exception is made for
subjects with a history of latent TB and documentation of having completed appropriate
treatment for latent TB 3 years prior to the first administration of study agent. It is the
responsibility of the investigator to verify the adequacy of previous antituberculous
treatment and provide appropriate documentation.
7.2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical
examination.
7.3. Have had no close contact with a person with active TB or, if there has been such a
contact, will be referred to a physician specializing in TB to undergo additional
evaluation, and if warranted, receive appropriate treatment as if having latent TB prior to
or simultaneously with the first administration of study agent.
7.4. Within 6 weeks prior to the administration of study agent, either have a negative
QuantiFERON-TB Gold test result 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 either prior to or simultaneously with the first
administration of study agent.
7.5. In the event of 2 indeterminate QuantiFERON-TB Gold in-tube tests results, the
subjects will be treated as if having latent TB prior or simultaneously with the first
administration of study agent.
7.6. Have a chest radiograph (posterior-anterior view), read by a qualified radiologist,
whose diagnostic assessment is consistent with no evidence of current active TB or old
inactive TB, and taken within 12 months of the study.
7.7. Have a screening laboratory test result as follows: 7.7.1. Hb=8.5 g/dL or =5.3 mmol/L
7.7.2. White blood cell (WBC) count =3.5x103 cells/uL 7.7.3. Neutrophils =1.5 x103 cells/uL
7.7.4. Platelets =100x103 cells/uL 7.7.5. Serum alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal
(UKN) for the central laboratory conducting the test.
7.7.6. Serum creatinine not exceeding 1.5 mg/dL
Exclusion Criteria:
1. Received previous treatment with any DMARDs.
2. Received previous treatment with golimumab or other tumour necrosis factor inhibitor
(TNFi) or other biologic drugs.
3. Any chronic inflammatory arthritis diagnosed before 16 years old. Exclusions for
general safety
Patients with significant concurrent medical diseases including uncompensated congestive
heart failure, myocardial infarction within 52 weeks from screening, unstable angina
pectoris, uncontrolled hypertension (BP>160/95), severe pulmonary disease, or history of
human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, central nervous
system (CNS) demyelinating events suggestive of multiple sclerosis, renal or
gastrointestinal conditions, which in the opinion of the investigator places the patient at
an unacceptable risk for participation in the study or would make implementation of the
protocol difficult.
Patients with cancer or a history of cancer (other than resected cutaneous basal cell
carcinoma, and in situ cervical cancer) within 5 years of screening.
Patients with current crystal or infective arthritis. Patients with chronic infection of
the upper respiratory tract (eg. Sinusitis), chest (eg. Bronchiectatic lung disease),
urinary tract or skin (eg. Paronychia, chronic ulcers, open wounds) within 4 weeks of
screening.
Patients who 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, histoplasmosis or coccidioidomycosis.
Patients with any ongoing or active infection or any major episode of infection requiring
hospitalization or treatment with IV antibiotics within the preceding 30 days of screening
and/or orally administered antibiotics in the preceding 15 days of screening.
Patients with abnormal liver function including known liver cirrhosis, fibrosis, or known
alcoholic steatohepatitis (NASH) at the time of screening or abnormal blood tests as shown
by:
Aminotransferase (AST) / alanine aminotransferase (ALT) > 3x ULN, OR Bilirubin >51umol/L
Patients with known severe hypoproteinaemia at the time of screening, e.g. in nephrotic
syndrome or impaired renal function, as shown by:
• Serum Creatinine > 133 mol/L
Patients with known significantly impaired bone marrow function as for example significant
anaemia, leukopaenia, neutropaenia or thrombocytopaenia as shown by the following
laboratory values at the time of screening:
White blood cells < 3000 x 106/L Platelets < 125 x 109/L Haemoglobin < 9.0 g/dL for males
and < 8.5 g/dL for females Patients with a history of latent or active TB prior to
screening will not be eligible. For exceptions refer to inclusion criteria.
Subjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes
testing for HBsAg (surface antigen), anti-HBs (surface antibody), and anti-HBc total (core
antibody total).
11.1. Subjects who test positive for surface antigen (HBsAg+) are not eligible for this
study, regardless of the results of other hepatitis B tests.
11.2. Subjects who test negative for surface antibody (HBsAg-) and test positive for core
antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.
11.3. Subjects who test positive only for surface antibody (anti-HBs+) are eligible for
this study.
11.4. Subjects who test positive only for core antibody (anti-HBc+) must undergo further
testing for hepatitis B deoxyribonucleic acid (HBV DNA test). If the HBV DNA test is
positive, the subject is not eligible for this study. If the HBV DNA test is negative, the
subject is eligible for this study. In the event the DNA test cannot be performed, the
subject is not eligible for the study.
Primary or secondary immunodeficiency (history of or currently active) unless related to
primary disease under investigation.
Pregnancy, lactation (nursing) or women of child-bearing potential (WCBP) unwilling to use
an effective birth control measure (Appendix 1) whilst receiving treatment and after the
last dose of protocol treatment as indicated in the relevant SmPC/IB.
Men whose partners are of child-bearing potential but who are unwilling to use an effective
birth control measure whilst receiving treatment and after the last dose of protocol
treatment as indicated in the relevant SmPC/IB.
Patients who have received any corticosteroids within 4 weeks prior to screening.
Patients with a history of confirmed blood dyscrasia. Patients with a history of mental
illness that would interfere with their ability to comply with the study protocol.
Patients with a history of drug and/or alcohol abuse that would interfere with their
ability to comply with the study protocol.
Patients with a history of any viral hepatitis within 1 year of screening Patients who have
received or are expected to receive any live virus or bacterial vaccinations or treatments
that include live organisms (eg. a therapeutic infectious agent such as BCG that is
instilled into the bladder for the treatment of cancer) within 3 months prior to the first
administration of study agent, during the trial, or within 6 months after the last
administration of the study agent.
Patients who demonstrate Hypersensitivity to the active substance, or any of the excipients
detailed in the SmPC.
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