10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease

Rheumatoid Arthritis Clinical Trial

— ARCTIC-FORWARD  

Official title:

10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304013
• Other study ID #: DIA2021-1/ver 1
• Status: Recruiting
• Start date: December 22, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: March 2022
• Source: Diakonhjemmet Hospital
• Contact: Siri Lillegraven, PhD
• Phone: +47 93467767
• Email: siri.lillegraven[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The ARCTIC-FORWARD study is a multi-center prospective observational study investigating the long-term outcomes of rheumatoid arthritis (RA) patients who received structured treat-to-target therapy early in their disease. The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs.

Description:

Rheumatoid arthritis (RA) is one of the most common autoimmune diseases. Recent developments in RA treatment has shown to change the outcome of RA for the early stages of the disease, with very limited loss of work participation and high rates of disease activity remission. The data on the long-term outcome for patients who received early optimal treatment is much more limited, and it is of special clinical interest to know to what extent these patients should be monitored with regards to slowly evolving joint damage, subclinical inflammation, loss of physical function and loss of work participation.

The aim of this study is to assess clinical, radiographic and functional long-term outcomes of modern RA care and to identify risk factors for progressive disease.The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs. We will perform an extensive evaluation of all patients participating in the ARCTIC study 10 years after the initiation of structured treat-to-target therapy. Outcomes include disease activity, radiographic damage, functional status, DMARD use, extra-articular manifestations including interstitial lung disease, comorbidities, survival, work participation, health care resource use, and health related quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: All patients that entered the ARCTIC study are eligible for the follow-up study. The main inclusion criteria in the ARCTIC study were age 18-75 years, fulfilment of the 2010 ACR classification criteria for RA, DMARD naivety with indication from DMARD therapy, and symptom duration of less than two years.

Exclusion Criteria: Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Haukeland University Hospital	Bergen
Norway	Vestre Viken Hospital	Drammen
Norway	Haugesund Hospital, Helse Fonna	Haugesund
Norway	Revmatolog Anne Lindtner Noraas	Kristiansand
Norway	Sørlandet Hospital	Kristiansand
Norway	Østfold Hospital	Moss
Norway	Diakonhjemmet Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olavs hospital (Trondheim University hospital)	Trondheim
Norway	Martina Hansens Hospital	Viken

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of radiographs joint damage	Radiographs of hands and feet	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Primary	Disease activity	Assessed by the disease activity score (DAS)	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Primary	Disease activity remission	Remission based on disease activity score (DAS)	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Primary	Physical and mental health	Assessed by SF-36	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Ultrasound inflammation	Power doppler and B-mode	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Grip strength	Measured by dynamometer	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Patient reported impact of disease	RAID	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Swollen joint count	44 joints	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Tender joint count	28 joints	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Tender joints	Assessed by Ritchie Articular index	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Comorbidities	Questionnaire	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	C-reactive protein (CRP)	Blood test	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Erythrocyte sedimentation rate (ESR)	Blood test	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Presence of rheumatoid noduli	Skin examination	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Osteoporosis	Assessed by Dual-energy X-ray absorptiometry (DEXA)	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Medication use	Record of disease modifying drugs antirheumatic drugs including corticosteroids	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Patient global assessment of disease activity	0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Physician global assessment of disease activity	0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Interstitial lung disease	Assessed by HRCT	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Physical activity level	Assessed by accelerometer	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Patient reported Physical function	Assessed by HAQ-PROMIS	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Health-related quality of life	Assessed by EQ-5D	10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Work Productivity	Work Productivity and Activity Impairment Questionnaire: WPAI:RA	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Secondary	Pulmonary function	Spirometry and DLCO	At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)