Table 1 Eligibility criteria for randomization into the GOLMePsA trial

1

Male and female subjects aged ≥18 years at the time of signing the Informed Consent Form.

2

Patients with a diagnosis of PsA and fulfilling CASPAR classification criteria confirmed within 24 months prior to the screening visit.

3

Patients with active PsA, defined by:

 • the presence of at least 3/68 tender joints AND at least 3/66 swollen joints;

OR

 • 2 swollen AND 2 tender joints, along with one affected entheseal site (Achilles tendon and/or plantar fascia).

4

Subjects capable of understanding and signing an Informed Consent Form prior to any trial-related procedure.

5

Women of childbearing potential (WCBP) or men capable of fathering children must be using adequate birth control measures (e. g.: 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 drugs. WCBP have to 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.

6

Patients with active current or latent tuberculosis (TB), including those diagnosed as a result of GOLMePsA trial screening procedures, who can provide adequate documentation of previous or were recently commenced on adequate anti-TB treatment according to local practice guidelines prior to the start of protocol treatment.

7

Planned surgery within the study period which is expected to require omission of any study medication of 28 days or more

8

Patient who have received previous treatment with any sDMARD.

9

Patient who have received previous treatment with golimumab or other TNFi or other biologic or investigational drugs.

10

Any chronic inflammatory arthritis diagnosed before 16 years of age.

11

Patients with current crystal or septic arthritis.

12

The candidates ineligible to (see Table 4) or unsuccessful in bearing the WB-MRI procedures will not be excluded from the study.

13

Patient who have received any corticosteroids within 4 weeks prior to screening.

14

Patients with significant concurrent medical conditions including:

• Uncompensated congestive heart failure;

• Myocardial infarction within 52 weeks from screening;

• Unstable angina pectoris;

• Uncontrolled arterial hypertension (blood pressure > 160/95 mmHg);

• Severe pulmonary disease;

• History of human immunodeficiency virus infection or immunodeficiency syndromes;

• Central nervous system demyelinating events suggestive of multiple sclerosis;

• Renal or gastrointestinal conditions;

Which in the opinion of the investigator place the patient at an unacceptable risk for participation in the study or would make implementation of the protocol difficult.

15

Patients with cancer or a history of cancer (other than resected cutaneous basal cell carcinoma and in situ uterine cervical cancer) within 5 years of screening.

16

Patients with chronic infections of the upper respiratory tract (e. g.: Sinusitis), chest (e. g.: Bronchiectatic lung disease), urinary tract or skin (e. g.: Paronychia, chronic ulcers, open wounds) within 4 weeks of screening.

17

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 (for TB exceptions refer also to inclusion criteria 6), histoplasmosis or coccidioidomycosis.

18

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.

19

Patients with abnormal liver function including known liver cirrhosis, fibrosis, or known non-alcoholic steato-hepatitis at the time of screening or abnormal blood tests as shown by:

 • Aspartate aminotransferase / alanine aminotransferase >3× upper limit of normality,

OR

 • Bilirubin >51 μmol/L.

20

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 μmol/L.

21

Patients with known significantly impaired bone marrow function, e. g. significant anaemia, leukopaenia, neutropaenia or thrombocytopaenia, as shown by the following laboratory values at the time of screening:

 • White blood cells <3000 × 10^6/L;

 • Platelets <125 × 10^9/L;

 • Haemoglobin <90 g/L for males and <85 g/L for females.

22

Patients with a history of untreated latent or active TB prior to screening will not be eligible (for exceptions refer to inclusion criteria 6).

23

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).

 • Subjects who test positive for surface antigen (HBsAg+) are not eligible for this study, regardless of the results of other hepatitis B tests.

 • Subjects who test negative for surface antigen (HBsAg-) and test positive for core antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.

 • Subjects who test positive only for surface antibody (anti-HBs+) are eligible for this study.

 • Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for HBV 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.

24

Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.

25

Pregnancy, lactation (nursing) or WCBP unwilling to use an effective birth control measure (detailed in the inclusion criteria 5) whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant Summary of Product Characteristics (SmPC)/Investigator Brochure (IB).

26

Men unwilling, or whose partners are WCBP who are unwilling to use an effective birth control measure (detailed in the inclusion criteria 5) whilst receiving treatment and after the last dose of protocol treatment as indicated in the relevant SmPC/IB.

27

Patients with a history of confirmed blood dyscrasia.

28

Patients with a history of mental illness that would interfere with their ability to comply with the study protocol.

29

Patients with a history of drug and/or alcohol abuse that would interfere with their ability to comply with the study protocol.

30

Patients with a history of any viral hepatitis within 1 year of screening.

31

Patients who have received or are expected to receive any live virus or bacterial vaccinations or treatments that include live organisms (e. g.: a therapeutic infectious agent such as the bacillus of Calmette-Guerin (BCG) that is instilled into the bladder for the treatment of cancer) within 3 months prior to the first administration of the investigational medicinal product (IMP) and/or non investigational medicinal products (NIMPs), during the trial, or within 6 months after the last administration of the IMP and/or NIMPs.

32

Patients who demonstrate hypersensitivity to the IMP and/or NIMPs, or any of the excipients detailed in the relevant SmPC.