NCT01205854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

4.6 years

First QC Date

September 16, 2010

Last Update Submit

April 15, 2015

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisultrasonographyremissionimaging remissiontight controltreat to target

Outcome Measures

Primary Outcomes (1)

  • Complete clinical Disease Activity Score (DAS) remission

    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)

    24 months

Secondary Outcomes (25)

  • Magnetic Resonance Imaging (MRI) of dominant hand

    24 months

  • American College of Rheumatology (ACR) response

    24 months

  • Remission

    24 months

  • European League Against Rheumatism (EULAR) response

    24 months

  • Work performance

    24 months

  • +20 more secondary outcomes

Study Arms (2)

Conventional clinical and laboratory assessment

NO INTERVENTION

Conventional assessment plus ultrasonography

EXPERIMENTAL
Device: Ultrasonography

Interventions

UltrasonographyDEVICE

Standardized ultrasonographic assessment of 32 joints, assessed for both grey scale synovitis and power doppler signal, at each visit. Dose escalations based on DAS response in combination with change in US score. All joints with US Power Doppler signal are targets for intra articular injections.

Conventional assessment plus ultrasonography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant, non-nursing female
  • \> 18 years of age and \< 75 years of age
  • Patients classified as having RA (according to new ACR/EULAR criteria)
  • Disease duration less than 2 years (defined as time from 1st joint swelling)
  • The treating rheumatologist decides the patient requires treatment with a Disease Modifying Anti-Rheumatic Drug (DMARD)
  • The patient has taken no prior DMARD
  • Patients able and willing to give written informed consent and comply with the requirements of the study protocol

You may not qualify if:

  • Abnormal renal function (serum creatinine \> 142 µmol/L in female and \> 168 µmol/L in male)
  • Abnormal liver function, active or recent hepatitis, cirrhosis
  • Major co-morbidities like severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease and/or severe respiratory diseases.
  • Leukopenia and/or thrombocytopenia
  • Inadequate birth control conception, pregnancy, and/or breastfeeding
  • Indications of active tuberculosis
  • Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Helse Bergen HF, Haukeland University Hospital, Dept. of Rheumatology

Bergen, Bergen, 5021, Norway

Location

Martina Hansens Hospital AS

Sandvika, Bærum, 1306, Norway

Location

Vestre Viken HF, Dept. of Rheumatology

Drammen, Drammen, 3004, Norway

Location

Sykehuset Østfold HF, Dept. of Rheumatology

Moss, Fredrikstad, 1603, Norway

Location

Haugesund Sanitetsforening Revmatismesykehus

Haugesund, Haugesund, 5504, Norway

Location

Sørlandet Sykehus HF, Dept. of Rheumatology

Kristiansand, Kristiansand, 4604, Norway

Location

Diakonhjemmet Sykehus AS, Dept. of Rheumatology

Oslo, Oslo County, 0319, Norway

Location

Universitetssykehuset Nord-Norge HF, Dept. of Rheumatology

Tromsø, Tromsø, 9038, Norway

Location

St Olavs Hospital HF, Dept. of Rheumatology

Trondheim, Trondheim, 7006, Norway

Location

Revmatologene bendvold/Dovland

Kristiansand, 4611, Norway

Location

Helse Sunnmøre HF, Dept. of Rheumatology

Ålesund, Ålesund, 6026, Norway

Location

Related Publications (10)

  • Sundin U, Aga AB, Skare O, Nordberg LB, Uhlig T, Hammer HB, van der Heijde D, Kvien TK, Lillegraven S, Haavardsholm EA; ARCTIC study group. Conventional versus ultrasound treat to target: no difference in magnetic resonance imaging inflammation or joint damage over 2 years in early rheumatoid arthritis. Rheumatology (Oxford). 2020 Sep 1;59(9):2550-2555. doi: 10.1093/rheumatology/kez674.

    PMID: 31999341DERIVED

  • Paulshus Sundlisaeter N, Olsen IC, Aga AB, Hammer HB, Uhlig T, van der Heijde D, Kvien TK, Lillegraven S, Haavardsholm EA; ARCTIC study group. Predictors of sustained remission in patients with early rheumatoid arthritis treated according to an aggressive treat-to-target protocol. Rheumatology (Oxford). 2018 Nov 1;57(11):2022-2031. doi: 10.1093/rheumatology/key202.

    PMID: 30053199DERIVED

  • Jonsson MK, Hensvold AH, Hansson M, Aga AB, Sexton J, Mathsson-Alm L, Cornillet M, Serre G, Lillegraven S, Fevang BS, Catrina AI, Haavardsholm EA. The role of anti-citrullinated protein antibody reactivities in an inception cohort of patients with rheumatoid arthritis receiving treat-to-target therapy. Arthritis Res Ther. 2018 Jul 13;20(1):146. doi: 10.1186/s13075-018-1635-7.

    PMID: 30001740DERIVED

  • Paulshus Sundlisaeter N, Aga AB, Olsen IC, Hammer HB, Uhlig T, van der Heijde D, Kvien TK, Lillegraven S, Haavardsholm EA; ARCTIC study group. Clinical and ultrasound remission after 6 months of treat-to-target therapy in early rheumatoid arthritis: associations to future good radiographic and physical outcomes. Ann Rheum Dis. 2018 Oct;77(10):1421-1425. doi: 10.1136/annrheumdis-2017-212830. Epub 2018 Jun 22.

    PMID: 29934373DERIVED

  • Nordberg LB, Lillegraven S, Aga AB, Sexton J, Lie E, Hammer HB, Olsen IC, Uhlig T, van der Heijde D, Kvien TK, Haavardsholm EA. The Impact of Ultrasound on the Use and Efficacy of Intraarticular Glucocorticoid Injections in Early Rheumatoid Arthritis: Secondary Analyses From a Randomized Trial Examining the Benefit of Ultrasound in a Clinical Tight Control Regimen. Arthritis Rheumatol. 2018 Aug;70(8):1192-1199. doi: 10.1002/art.40494. Epub 2018 Jun 29.

    PMID: 29575737DERIVED

  • Jonsson MK, Sundlisaeter NP, Nordal HH, Hammer HB, Aga AB, Olsen IC, Brokstad KA, van der Heijde D, Kvien TK, Fevang BS, Lillegraven S, Haavardsholm EA. Calprotectin as a marker of inflammation in patients with early rheumatoid arthritis. Ann Rheum Dis. 2017 Dec;76(12):2031-2037. doi: 10.1136/annrheumdis-2017-211695. Epub 2017 Aug 16.

    PMID: 28814431DERIVED

  • Aga AB, Berner Hammer H, Christoffer Olsen I, Uhlig T, Kvien TK, van der Heijde D, Fremstad H, Madland TM, Lexberg AS, Haukeland H, Rodevand E, Hoili C, Stray H, Noraas AL, Widding Hansen IJ, Bakland G, Lillegraven S, Lie E, Haavardsholm EA. Development of a feasible and responsive ultrasound inflammation score for rheumatoid arthritis through a data-driven approach. RMD Open. 2016 Dec 16;2(2):e000325. doi: 10.1136/rmdopen-2016-000325. eCollection 2016.

    PMID: 28074154DERIVED

  • Haavardsholm EA, Aga AB, Olsen IC, Lillegraven S, Hammer HB, Uhlig T, Fremstad H, Madland TM, Lexberg AS, Haukeland H, Rodevand E, Hoili C, Stray H, Noraas A, Hansen IJ, Bakland G, Nordberg LB, van der Heijde D, Kvien TK. Ultrasound in management of rheumatoid arthritis: ARCTIC randomised controlled strategy trial. BMJ. 2016 Aug 16;354:i4205. doi: 10.1136/bmj.i4205.

    PMID: 27530741DERIVED

  • Nordberg LB, Lillegraven S, Lie E, Aga AB, Olsen IC, Hammer HB, Uhlig T, Jonsson MK, van der Heijde D, Kvien TK, Haavardsholm EA; and the ARCTIC working group. Patients with seronegative RA have more inflammatory activity compared with patients with seropositive RA in an inception cohort of DMARD-naive patients classified according to the 2010 ACR/EULAR criteria. Ann Rheum Dis. 2017 Feb;76(2):341-345. doi: 10.1136/annrheumdis-2015-208873. Epub 2016 Apr 19.

    PMID: 27094444DERIVED

  • Aga AB, Hammer HB, Olsen IC, Uhlig T, Kvien TK, van der Heijde D, Fremstad H, Madland TM, Lexberg AS, Haukeland H, Rodevand E, Hoili C, Stray H, Bendvold AN, Soldal DM, Bakland G, Lie E, Haavardsholm EA. First step in the development of an ultrasound joint inflammation score for rheumatoid arthritis using a data-driven approach. Ann Rheum Dis. 2016 Aug;75(8):1444-51. doi: 10.1136/annrheumdis-2015-207572. Epub 2015 Jun 17.

    PMID: 26085490DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tore K Kvien, MD, PhD

    Diakonhjemmet Hospital AS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post. doctoral Researcher, MD Ph.D.

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

NO(11)