Table 2 Inclusion and exclusion criteria of the NORD-STAR study

Inclusion criteria

 Age ≥18 years

 RA according to ACR/EULAR 2010 criteria [55]

  < 24 months from arthritis symptom onset

 RF positive and/or ACPA positive and/or CRP ≥10 mg/L

 DAS28 CRP >3.2 [56]

  ≥ 2 swollen and ≥2 tender joints (based on a 66/68 joint count) [27]

 Female patients are either not of childbearing potential or use birth control (IUD, contraceptives or have a vasectomized partner)

 Female patients should have a negative serum or urine pregnancy test upon screening

 Judged to be in good general health based on medical history, physical examination, laboratory profile, chest X-ray and electrocardiogram

 Willingness to provide written informed consent

 Willingness to administer s.c. injections or receive these by trained personnel

Exclusion criteria

 Previous DMARD therapy for rheumatic diseases

 Current active inflammatory joint disease other than RA

 Received prednisone (or equivalent) dose >7.5 mg/day or dose adjustment within the preceding 4 weeks

 Received i.a. or parenteral administration of glucocorticoids within the preceding 4 weeks

 Undergone joint surgery within the preceding 2 months (at joints assessed in the study)

 Diagnosed with chronic arthritis before age of 17 years

 History with allergic reactions or significant sensitivity to constituents of study drugs

 Treated with any investigatory drugs within the preceding month

 Active infection of any kind (except fungal infections of nail beds)

 Active infection or infection requiring hospitalization within 4 weeks of screening

 Poorly controlled medical condition which, in the opinion of the investigator, would put the subject at risk by participation in the study

 History of clinically significant hematologic, liver or renal disease

 Neurologic symptoms suggestive of CNS demyelinating disease and/or diagnosis of central demyelinating disease

 History of cancer or lymphoproliferative disease (successfully treated cutaneous squamous cell or basal cell carcinoma, localized carcinoma in situ of the cervix and curatively treated malignancy >5 years prior to screening are allowed)

 History of listeriosis/histoplasmosis/untreated tuberculosis or persistent chronic infections, or recent active infections requiring hospitalization or treatment with i.v. anti-infectives within 30 days or orally administered anti-infectives within 14 days prior to baseline visit

 Latent tuberculosis

 Severely immunocompromised

 Female patients who are breastfeeding, pregnant or considering becoming pregnant during the study or within 150 days after the last dose of study medication

 Male patients who are planning to father a child during the time they are included in the study

 Clinically significant drug or alcohol usage during the preceding year

 Chronic widespread pain syndrome

 Considered by the investigator to be an unsuitable candidate for the study

 Unwilling to comply with study protocol

 Abnormal screening laboratory results (ASAT/ALAT >1.75 times ULN, positive serum hCG, positive test for hepatitis B and/or C, creatinine levels >2 times ULN, hemoglobin <90 g/L, absolute neutrophil count <1.5 × 10³/μL, serum total bilirubin ≥1.5 mg/dL)