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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