Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission

NCT06783322 | Not Yet Recruiting

• 1 other identifier: DS-00887
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

remission; tapering; drug-free remission; long-term outcomes

Outcome Measures

Primary Outcomes (6)

• Disease activity remission status

  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).

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Disease Modifying Anti-Rheumatic Drug (DMARD)-free remission

  The prevalence of DMARD-free remission

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Radiographic score (van der Heijde modified Sharp score (vdHSS)

  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.

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Radiographic joint damage progression

  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.

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Disease activity composite measures

  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

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Patient reported physical function

  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.

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

Secondary Outcomes (20)

• Health-related quality of life

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Patient global assessment of disease activity

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Physician global assessment of disease activity

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Ultrasound inflammation

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

• Swollen joint count

  Assessed at the visit 10- and 15-year after the initial inclusion into the ARCTIC REWIND trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of men and women with established rheumatoid arthritis who have experienced sustained remission and participated in the ARCTIC REWIND trial. All the 259 patients that entered the ARCTIC REWIND trial are eligible to participate in the extension study.

You may qualify if:

• Participation in the ARCTIC REWIND trial
• Patients able and willing to give written informed consent and comply with the requirements of the study protocol

You may not qualify if:

• Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• The Research Council of Norway: collaborator
• Olav Thon Foundation: collaborator

Study Sites (10)

Ålesund Hospital

Ålesund, Norway

Location

Haukeland University Hospital

Bergen, Norway

Location

Vestre Viken Hospital

Drammen, Norway

Location

Sørlandet Hospital

Kristiansand, Norway

Location

Revmatismesykehuset

Lillehammer, Norway

Location

Helgelandssykehuset Mo i Rana

Mo i Rana, Norway

Location

Østfold Hospital

Moss, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

Martina Hansens Hospital

Sandvika, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, buffy coat, PBMC, RNA storage tubes and full blood

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Nina Paulshus Sundlisæter, MD PhD

CONTACT

+47 22451500; ninasundlisater@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 20, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: March 10, 2025

Record last verified: 2025-02

Locations

NO (10)