NCT01752309

Brief Summary

Rheumatoid arthritis a chronic and progressive inflammatory disease characterized by synovial membrane inflammation, possibly leading to destruction of joints. To start early with a combination therapy results in a better outcome for patients. Using ultrasonography it is possible to detect clinically and radiographically absent synovitis and erosions. However, it is unclear whether or not these findings have predictive value in these patients regarding disease activity or radiographical progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

Geographic Reach
1 country

7 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

June 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

December 12, 2012

Last Update Submit

November 18, 2014

Conditions

Rheumatoid ArthritisPredictive Value of Ultrasound in Early Rheumatoid Arthritis

Keywords

Early Rheumatoid arthritisRheumatoid arthritisUltrasoundPredictivePrognosis

Outcome Measures

Primary Outcomes (1)

  • Persistence of active disease after one year, defined as a Disease Activity Score of 44 joints (DAS44) > 3.4

    One year after inclusion in the study

Secondary Outcomes (1)

  • Change in Sharp vd Heijde score during the year of inclusion

    At date of inclusion and after one year

Other Outcomes (1)

  • Change of DAS over time

    At date of inclusion, after 3 months and after one year

Study Arms (1)

Rheumatoid Arthritis, ultrasound, persistence disease activity

Patients diagnosed with early Rheumatoid Arthritis will be assessed three times in one year with ultrasound to evaluate the predictive value of ultrasound.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Starting in June 2010, all newly diagnosed rheumatoid arthritis patients who will be participating in 2 ongoing trials will be invited to participate in this study. In Almelo they will be recruited from the outpatient Rheumatology clinic.

You may qualify if:

  • Newly diagnosed rheumatoid arthritis patients, diagnosed according to the American College of Rheumatology (ACR) 1987-criteria
  • Naïve for Disease Modifying Anti Rheumatic Drugs (DMARDs), biologicals and glucocorticoids.
  • Starting with treatment with a potent anti-rheumaticum. E.g. methotrexate (MTX), biologicals or glucocorticoids.

You may not qualify if:

  • Contra-indications for MTX, biologicals or glucocorticoids.
  • Insufficient ability to read and write in Dutch
  • Personality disorders that limit the participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Medical Center Alkmaar

Alkmaar, North Holland, 1815JD, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Overijssel, 7609PP, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, South Holland, 3300AK, Netherlands

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015GE, Netherlands

Location

Maasstad Hospital

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Vlietland Hospital

Schiedam, South Holland, 3118JH, Netherlands

Location

University Medical Center Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

Related Publications (1)

  • Ten Cate DF, Jacobs JWG, Swen WAA, Hazes JMW, de Jager MH, Basoski NM, Haagsma CJ, Luime JJ, Gerards AH. Can baseline ultrasound results help to predict failure to achieve DAS28 remission after 1 year of tight control treatment in early RA patients? Arthritis Res Ther. 2018 Jan 30;20(1):15. doi: 10.1186/s13075-018-1514-2.

    PMID: 29382379DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jolanda J. Luime, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David F. Ten Cate, MD

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 19, 2012

Study Start

June 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

NL(7)