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Table 2 Poor prognostic factors used as inclusion criteria in randomized controlled trials

From: Poor prognostic factors guiding treatment decisions in rheumatoid arthritis patients: a review of data from randomized clinical trials and cohort studies

Trial Inclusion criteria Primary endpoint Secondary endpoints
AGREE [45] RA (1987) ≤2 years, MTX-naïve
Poor prognosis: RF/ACPA-positive, SJC ≥10, TJC ≥12, CRP ≥4.5 mg/l, erosions
Remission (DAS28-CRP <2.6)
Joint damage (TSS) at 1 year
ACR response DAS28-CRP
HAQ-DI, HRQoL improvement
Radiologic nonprogression
TEAR [42] RA (1987) <3 years, biologic DMARD-naïve
Poor prognosis: RF/ACPA positive or radiologic erosions
Active: SJC ≥4, TJC ≥4 (28 joints), DAS28-ESR >3.2
DAS28-ESR at week 48 and 102 ACR response
Modified HAQ
Joint damage
C-EARLY [40] RA (2010) ≤1 year, DMARD-naïve
poor prognosis (RF/ACPA-positive)
Active RA: SJC ≥4, TJC ≥4, DAS28-ESR >3.2, ESR ≥28 or CRP ≥10 mg/l
Sustained remission (DAS28-ESR <2.6) or low disease activity (<3.2) at week 40 and 52 ACR response HAQ-DI
TSS (change from baseline)
At week 52
C-OPERA [6] RA (2010) ≤1 year, MTX-naïve
Poor prognosis (ACPA ≥3× upper limit of normal and RF-positive and/or erosions
Active RA: DAS28-ESR ≥3.2
Non-progression (defined: mTSS ≤0.5 change from baseline to 12 months) SDAI, Boolean and DAS28-ESR
HAQ-DI
ACR response
FUNCTION [41] RA (1987) ≤2 years, MTX-naïve
Poor prognosis: RF/ACPA-positive or radiologic erosions
Active RA: DAS28-ESR >3.2, SJC ≥4 (66 joints), TJC ≥6 (68 joints), ESR ≥28 or CRP ≥10 mg/l
Remission (DAS28-ESR <2.6 at week 24 ACR response
Modified TSS
SF-36
CareRA [46] RA (1987) ≤1 year, DMARD-naïve
Lack of poor prognosis: no erosions, DAS ≤3.2, seronegative
Remission (DAS28-CRP ≤3.2) at week 16 EULAR response
HAQ response
Cumulative disease activity
  1. ACPA anti-citrullinated protein-peptide antibodies, ACR American College of Rheumatology, CRP C-reactive protein, ESR erythrocyte sedimentation rate, EULAR European League Against Rheumatism, HAQ-DI Health Assessment Questionnaire Damage Index, HRQoL health-related quality of life, MTX methotrexate, DAS disease activity score, DMARD disease-modifying antirheumatic drug, TSS Total Sharp Score, RA rheumatoid arthritis, RF rheumatoid factor, SDAI Simple Disease Activity Index, SF-36 Short Form-36, SJC swollen joint count, TJC tender joint count