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

From: Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 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)
  1. Abbreviations: RA rheumatoid arthritis, ACR American College of Rheumatology, EULAR European League Against Rheumatism, RF rheumatoid factor, ACPA anti-citrullinated peptide antibody, CRP C-reactive protein, DAS Disease Activity Score, IUD intra-uterine device, s.c. subcutaneous, DMARD disease-modifying antirheumatic drugs, i.a. intra-articular, i.v. intravenous, ASAT aspartate transaminase, ALAT alanine transaminase, ULN upper limit of normal, hCG human chorionic gonadotropin