Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission

Condition(s) studied

Study summary

The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources.

The investigators will perform an extensive evaluation of all patients who participated in the ARCTIC REWIND study 10 and 15 years after they achieved sustained remission and received different treatment strategies.

Eligibility

Primary outcome measure(s)

• Disease activity remission status — Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
  Remission status will be assessed according to e.g the disease activity score DAS, the Simplified Disease Activity Index (SDAI) and ACR/EULAR Boolean 2.0 remission. DAS includes the ritchie articular index, the swollen joint count (based on 44 joints), the ESR and the Patient's Global Assessment of disease activity on a VAS 0-100 mm (PGA). The following cut-points are used: High disease activity: DAS \> 3.7; Moderate disease activity: 3.7 ≥ DAS\>2.4; Low disease activity: 2.4 ≥ DAS ≥ 1.6; In remission: DAS \< 1.6 The SDAI includes tender and swollen joints (of 28), PGA, PhGA and CRP. According to SDAI, the following cut-points are used: High disease activity: SDAI\> 26.0; Moderate disease activity: 26.0 ≥ SDAI\>11.0; Low disease activity: 11.0 ≥ SDAI \> 3.3; In remission: SDAI ≤ 3.3 ACR/EULAR 2.0 remission is defined as the combination of tender joints ≤ 1, swollen joints ≤ 1, CRP ≤ 1 and patient global assessment ≤ 2 (on a scale 0-10).
• Disease Modifying Anti-Rheumatic Drug (DMARD)-free remission — Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
  The prevalence of DMARD-free remission
• Radiographic score (van der Heijde modified Sharp score (vdHSS) — Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
  Radiographs of hands and feet. The van der Heijde-modified Sharp scoring method will be used, which assesses erosions in 16 joints of each hand (range, 0-5 for each joint) and in 6 joints of each foot (range, 0-10 per joint) and joint space narrowing in 15 joints for each hand and in 6 joints for each foot (range, 0-4 per joint).This gives scores for erosions on a scale from 0 to 280 and joint space narrowing on a scale from 0 to168, thus the total van der Heijde-modified Sharp score ranges from 0 to 448, with higher scores indicating greater joint damage.
• Radiographic joint damage progression — Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
  Radiographs of hands and feet. The van der Heijde-modified Sharp scoring method will be used, which assesses erosions in 16 joints of each hand (range, 0-5 for each joint) and in 6 joints of each foot (range, 0-10 per joint) and joint space narrowing in 15 joints for each hand and in 6 joints for each foot (range, 0-4 per joint).This gives scores for erosions on a scale from 0 to 280 and joint space narrowing on a scale from 0 to168, thus the total van der Heijde-modified Sharp score ranges from 0 to 448, with higher scores indicating greater joint damage. The images will be compared to the last corresponding images undertaken in the ARCTIC REWIND trial. Progression will be calculated as e.g. annual increase in van der Heijde modified Sharp score ≥ 1 unit.
• Disease activity composite measures — Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
  The following composite measures will be included: disease activity score (DAS), DAS based on 28 joint counts (DAS28), the simplified disease activity index (SDAI) and the clinical disease activity index (CDAI). These are based on tender and swollen joint counts, the PGA, acute phase reactants (except from CDAI), and, for SDAI and CDAI also the PhGA. DAS: High disease activity: DAS \> 3.7; Moderate disease activity: 3.7 ≥ DAS\>2.4; Low disease activity: 2.4 ≥ DAS ≥ 1.6; In remission: DAS \< 1.6 DAS28: High disease activity: DAS28 \> 5.1; Moderate disease activity: 5.1 ≥ DAS28\>3.2; Low disease activity: 3.2 ≥ DAS28 ≥ 2.6; In remission: DAS28 \< 2.6 CDAI: High disease activity: CDAI \> 22.0; Moderate disease activity: 22.0 ≥ CDAI\>10.0; Low disease activity: 10.0 ≥ CDAI \> 2.8; In remission: CDAI ≤ 2.8 SDAI: High disease activity: SDAI\> 26.0;Moderate disease activity: 26.0 ≥ SDAI\>11.0; Low disease activity: 11.0 ≥ SDAI; In remission SDAI ≤ 3.3
• Patient reported physical function — Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial
  The Patient-Reported Outcomes Measurement Information (PROMIS) HAQ (Health Assessment Questionnaire ) 20-item short form will be used in this study. Each question has five response options, ranging in value from one to five. To find the total raw score, the sum of the values of the response to each question is calculated, giving a range in scores from 20 to 100 if all questions are answered. The total raw score should be translated into a T-score for each participant (either by standardized conversion tables or using item-level calibrations), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD worse than average.

Trial sites (10)

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