Table 1

Population/intervention/comparator/outcome/study design and search criteria for the systematic review

CriteriaInclusion
Study designRandomised controlled trials above phase I
(including crossover studies up to time of crossover)
Population
  • Adult patients (18 years or older) with moderately to severely active rheumatoid arthritis who have had inadequate response to one or more csDMARD

  • Adult patients (18 years or older) with moderately to severely active rheumatoid arthritis who have had inadequate response to one or more anti-tumour necrosis factors

Treatment/interventionThe following interventions are of interest at any dosage or administration type:
  • Sarilumab (REGN88, SAR153191)

  • Adalimumab (Humira)

  • Certolizumab (Cimzia)

  • Etanercept (Enbrel)

  • Golimumab (Simponi)

  • Infliximab (Remicade)

  • Abatacept (Orencia)

  • Rituximab (MabThera/Rituxan)

  • Tocilizumab (RoActemra/Actemra)

  • Tofacitinib (Xeljanz)

  • SB4 (Samsung Bioepis)

  • GP2015 (Sandoz)

  • ABP501 (Amgen)

  • BI695501 (Boehringer)

  • SB5 (Samsung Bioepis)

  • Remsima (CT-P13)

  • SB2 (Samsung Bioepis)

  • Inflectra (CT-P13)

  • Flixabi (Biogen)

  • Rituxan (GP2013)

  • Baricitinib (LY3009104, INCB028050)

ComparatorPlacebo or any of the above listed treatments in combination with a csDMARD(s) (ie, methotrexate, leflunomide, hydroxychloroquine, minocycline, sulfasalazine, azathioprine, sodium aurothiomalate and auranofin) or csDMARD as monotherapy or in combination with other csDMARD(s).
OutcomesEfficacy, safety and patient-reported outcomes at 24 weeks (±4 weeks) and 52 weeks (±8 weeks).
TimeNo limit on time horizon.
LanguageEnglish language.
  • csDMARD, conventional disease-modifying antirheumatic drugs.