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. 2012 Dec 17;6:429–464. doi: 10.2147/BTT.S36707

Table 1.

Summary of inclusion criteria for the systematic review and meta-analysis

Study design Phase II or III prospective, randomized controlled trials with at least one treatment arm containing a bDMARD combination therapy or bDMARD monotherapy
Population Adult patients (≥18 years) meeting the ACR classification criteria for rheumatoid arthritis
Previously treated with MTX or other DMARD
≤15% of patients previously treated with TNF-α inhibitors
Interventions Any bDMARD licensed in the EU
Studies needed to include at least one treatment arm of bDMARD in combination with a DMARD or as a monotherapy
No restrictions to drug dose or formulation, mode of delivery or duration of treatment
Comparators DMARD (combination analysis) or placebo (monotherapy analysis)
Other comparators where needed to connect the network or preserve randomization
Outcomes ACR 20/50/70 response rate to treatment (defined as a 20%, 50%, or 70% improvement in the ACR score)
Outcome reported between 12 and 30 weeks of follow-up
Language of publication Non-English full-text papers were excluded, but English abstracts of non-English full-text papers were included

Abbreviations: ACR, American College of Rheumatology; bDMARD, biological disease-modifying antirheumatic drug; DMARD, disease-modifying antirheumatic drug; MTX, methotrexate; TNF-α, tumour necrosis factor-alpha.