Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: Ultrasonography

• Registration Number: NCT01205854
• Lead Sponsor: Espen A. Haavardsholm

Brief Summary

The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known.

Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US leads to better care for RA patients.

This study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional assessment plus ultrasonography	Ultrasonography	-

Primary Outcome Measures

Name	Time	Method
Complete clinical Disease Activity Score (DAS) remission	24 months	Specifically, the primary endpoint will be the proportion of patients with all the following criteria met at the end of the study (at 24 months): * DAS score \< 1.6 at visits 11, 12 and 13 (after 16, 20 and 24 months); * Absence of swollen joints at visits 11, 12 and 13 (after 16, 20 and 24 months); * No radiological progression between visit 11 (16 months) and visit 13 (24 months)

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI) of dominant hand	12 months	MRIs of dominant hand are scored according to the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) for synovitis, bone marrow edema and erosions, and Haavardsholm tenosynovitis score, as well as a novel joint space narrowing score will be applied.
American College of Rheumatology (ACR) response	12 months	Proportion of patients with ACR20, ACR50, ACR70 and ACR90 response.
Remission	12 months	Various definitions of remission will be calculated, including DAS-remission, ACR-remission, Simplified Diseases Activity Index (SDAI) remission and Clinical Disease Activity Index (CDAI) remission
European League Against Rheumatism (EULAR) response	12 months	EULAR good, moderate and non-response
Medical Outcomes Study Short-Form 36-item (SF-36)	12 months	The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Work performance	12 months	1. Absenteeism (work time missed); 2. Presenteeism (impairment at work / reduced on-the-job effectiveness); 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism); 4. Activity Impairment
Conventional radiography	12 months	Radiographs of hands (posterior/anterior) and foot (anterior/posterior) will be taken at baseline, 3, 6 and 12 months. The modified Sharp van der Heijde Score (vdHSS) will be calculated, including an erosion score and a joint space narrowing score.
EuroQol-5 Dimension (EQ-5D)	24 months	EQ-5D is a standardised instrument for use as a measure of health outcome.
The RA Impact of Disease (RAID) score	12 months	The RAID includes seven domains with the following relative weights: pain (21%), functional disability (16%), fatigue (15%), emotional well-being (12%), sleep (12%), coping (12%) and physical well-being (12%).
Health Assessment Questionnaire (HAQ-PROMIS)	12 months	The HAQ-PROMIS is a questionnaire evaluating the physical function in patients with RA.
Dual Energy X-ray Absorptiometry (DEXA) of spine and hip	12 months	Bone density measurements (DEXA hip and spine, both Z- and T-scores as well as bone mineral density) will be performed at baseline and after 12 and 24 months.
Disease Activity Score (DAS)	12 months	The DAS is a composite score that includes the Ritchie articular index (RAI), the 44- swollen joint counts (SJC-44), the Erythrocyte Sedimentation Rate (ESR) and a general health (GH) assessment on a Visual Analogue Scale (VAS).; The DAS is calculated as follows: DAS = 0.54\*sqrt(RAI) + 0.065\*(SJC-44) + 0.33\*Ln(ESR) + 0.0072\*GH
Ultrasonography (synovitis)	12 months	36 joints and 2 tendons will be scored for both grey scale and power doppler synovitis on a 0-3 scale.

Trial Locations

Locations (11)

Haugesund Sanitetsforening Revmatismesykehus; 🇳🇴 Haugesund, Norway

Martina Hansens Hospital AS; 🇳🇴 Sandvika, Bærum, Norway

Sykehuset Østfold HF, Dept. of Rheumatology; 🇳🇴 Moss, Fredrikstad, Norway

Helse Bergen HF, Haukeland University Hospital, Dept. of Rheumatology; 🇳🇴 Bergen, Norway

Vestre Viken HF, Dept. of Rheumatology; 🇳🇴 Drammen, Norway

Sørlandet Sykehus HF, Dept. of Rheumatology; 🇳🇴 Kristiansand, Norway

Revmatologene bendvold/Dovland; 🇳🇴 Kristiansand, Norway

Universitetssykehuset Nord-Norge HF, Dept. of Rheumatology; 🇳🇴 Tromsø, Norway

Diakonhjemmet Sykehus AS, Dept. of Rheumatology; 🇳🇴 Oslo, Norway

St Olavs Hospital HF, Dept. of Rheumatology; 🇳🇴 Trondheim, Norway

Helse Sunnmøre HF, Dept. of Rheumatology; 🇳🇴 Ålesund, Norway