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Rheumatoid ArthritisULTRAPRONCT03228342

Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

A study testing MusculoSkeletal Ultrasound in people with Rheumatoid Arthritis and Patient Reported Outcomes, run by Clínica de Artritis Temprana at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients classified in remission/low disease activity in terms of Patient Reported Outcomes. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
MusculoSkeletal Ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteMexico
Study dates
3 May 2017to 28 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A clinical diagnosis of RA made at the discretion of the attending experienced rheumatologist.
  • Patients classified in remission/low disease activity

Who cannot join

  • <16 years old.
  • Patient with recent trauma in the evaluated joints.
  • Luxation in the MCP, PIP or MTP joints.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City, 14000

Other trials in Mexico

About this study

Official title: The Impact of Musculoskeletal Ultrasound-added to Clinical Evaluations- on Patient Reported Outcomes: A Prospective Study of Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity (ULTRAPRO)

Evaluate the impact of MusculoSkeletal Ultrasound added to Rheumatoid Arthritis patients classified in remission/low disease activity in terms of Patient Reported Outcomes.

Being tested
MusculoSkeletal Ultrasound
Keywords
Rheumatoid Arthritis, Ultrasound, Impact
Medical subject headings
Arthritis, Rheumatoid, Tooth, Impacted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MusculoSkeletal UltrasoundDiagnostic test

    Patient will be assess with ultrasound (GUS-7 score) and the results will be informed to his/her attending Rheumatologist.

    The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.

  • MusculoSkeletal UltrasoundDiagnostic test

    Patient will be assess with ultrasound (GUS-7 score) and the results will not be informed to his/her attending Rheumatologist.

    The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization.

Study groups in NCT03228342
Study groupRoleWhat they receive
Ultrasound sharedExperimentalPatient will be assessed with ultrasound (GUS-7 score)
Receives: Diagnostic Test: MusculoSkeletal Ultrasound
Ultrasound not sharedExperimentalPatient will be assessed with ultrasound (GUS-7 score)
Receives: Diagnostic Test: MusculoSkeletal Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline of the Patient Reported Outcome (HAQ)

    Minimal Clinically Significant change in HAQ

    Measured: From baseline at 6 months

  2. Change from Baseline of the Patient Reported Outcome (RADAI)

    Minimal Clinically Significant change in RADAI

    Measured: from baseline at 6 months

  3. Change from Baseline of the Patient Reported Outcome (SF-36)

    Minimal Clinically Significant change in SF-36

    Measured: from baseline at 6 months

  4. Change from Baseline of the Patient Reported Outcome (VAS-Patient)

    Minimal Clinically Significant change in VAS-Patient

    Measured: from baseline at 6 months

Secondary outcomes (6)

  1. Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity

    Describe ultrasound findings at the moment of inclusion in the study.

    Measured: Baseline

  2. Clinical relapse: Proportion of patients with relapse after the intervention in both groups

    Describe the proportion of patients with relapse after the intervention in both groups.

    Measured: baseline and 6 months

  3. Change from Baseline of the Patient Reported Outcome (HAQ)

    Minimal Clinically Significant change in HAQ

    Measured: from baseline at 12 months

  4. Change from Baseline of the Patient Reported Outcome (RADAI)

    Minimal Clinically Significant change in RADAI

    Measured: from baseline at 12 months

  5. Change from Baseline of the Patient Reported Outcome (SF-36)

    Minimal Clinically Significant change in SF-36

    Measured: from baseline at 12 months

  6. Change from Baseline of the Patient Reported Outcome (VAS-Patient)

    Minimal Clinically Significant change in VAS-Patient

    Measured: from baseline at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start3 May 2017
  3. Primary completion28 Jan 2019
  4. Study completion28 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03228342
Sponsor's protocol ID
IRE-2218-17/19-1
Acronym
ULTRAPRO
Status last verified
Jan 2019
First submitted
3 May 2017
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Plaza M, Nowakowska-Plaza A, Pracon G, Sudol-Szopinska I. Role of ultrasonography in the diagnosis of rheumatic diseases in light of ACR/EULAR guidelines. J Ultrason. 2016 Mar;16(64):55-64. doi: 10.15557/JoU.2016.0006. Epub 2016 Mar 29.

    PubMed 27104003

  • Wakefield RJ, Gibbon WW, Conaghan PG, O'Connor P, McGonagle D, Pease C, Green MJ, Veale DJ, Isaacs JD, Emery P. The value of sonography in the detection of bone erosions in patients with rheumatoid arthritis: a comparison with conventional radiography. Arthritis Rheum. 2000 Dec;43(12):2762-70. doi: 10.1002/1529-0131(200012)43:123.0.CO;2-#.

    PubMed 11145034

  • Nakagomi D, Ikeda K, Okubo A, Iwamoto T, Sanayama Y, Takahashi K, Yamagata M, Takatori H, Suzuki K, Takabayashi K, Nakajima H. Ultrasound can improve the accuracy of the 2010 American College of Rheumatology/European League against rheumatism classification criteria for rheumatoid arthritis to predict the requirement for methotrexate treatment. Arthritis Rheum. 2013 Apr;65(4):890-8. doi: 10.1002/art.37848.

    PubMed 23334942

  • Terslev L, von der Recke P, Torp-Pedersen S, Koenig MJ, Bliddal H. Diagnostic sensitivity and specificity of Doppler ultrasound in rheumatoid arthritis. J Rheumatol. 2008 Jan;35(1):49-53. Epub 2007 Dec 15.

    PubMed 18172922

  • Peluso G, Michelutti A, Bosello S, Gremese E, Tolusso B, Ferraccioli G. Clinical and ultrasonographic remission determines different chances of relapse in early and long standing rheumatoid arthritis. Ann Rheum Dis. 2011 Jan;70(1):172-5. doi: 10.1136/ard.2010.129924. Epub 2010 Nov 19.

    PubMed 21097799

  • Dale J, Purves D, McConnachie A, McInnes I, Porter D. Tightening up? Impact of musculoskeletal ultrasound disease activity assessment on early rheumatoid arthritis patients treated using a treat to target strategy. Arthritis Care Res (Hoboken). 2014 Jan;66(1):19-26. doi: 10.1002/acr.22218.

    PubMed 24376248

  • Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, Kvien TK, Navarro-Compan MV, Oliver S, Schoels M, Scholte-Voshaar M, Stamm T, Stoffer M, Takeuchi T, Aletaha D, Andreu JL, Aringer M, Bergman M, Betteridge N, Bijlsma H, Burkhardt H, Cardiel M, Combe B, Durez P, Fonseca JE, Gibofsky A, Gomez-Reino JJ, Graninger W, Hannonen P, Haraoui B, Kouloumas M, Landewe R, Martin-Mola E, Nash P, Ostergaard M, Ostor A, Richards P, Sokka-Isler T, Thorne C, Tzioufas AG, van Vollenhoven R, de Wit M, van der Heijde D. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016 Jan;75(1):3-15. doi: 10.1136/annrheumdis-2015-207524. Epub 2015 May 12.

    PubMed 25969430

  • Galicia-Hernandez G, Parra-Salcedo F, Ugarte-Martinez P, Contreras-Yanez I, Ponce-de-Leon A, Pascual-Ramos V. Sustained moderate-to-high disease activity and higher Charlson score are predictors of incidental serious infection events in RA patients treated with conventional disease-modifying anti-rheumatic drugs: a cohort study in the treat-to-target era. Clin Exp Rheumatol. 2016 Mar-Apr;34(2):261-9. Epub 2016 Mar 3.

    PubMed 26939612

  • Backhaus M, Ohrndorf S, Kellner H, Strunk J, Backhaus TM, Hartung W, Sattler H, Albrecht K, Kaufmann J, Becker K, Sorensen H, Meier L, Burmester GR, Schmidt WA. Evaluation of a novel 7-joint ultrasound score in daily rheumatologic practice: a pilot project. Arthritis Rheum. 2009 Sep 15;61(9):1194-201. doi: 10.1002/art.24646.

    PubMed 19714611

  • Backhaus TM, Ohrndorf S, Kellner H, Strunk J, Hartung W, Sattler H, Iking-Konert C, Burmester GR, Schmidt WA, Backhaus M. The US7 score is sensitive to change in a large cohort of patients with rheumatoid arthritis over 12 months of therapy. Ann Rheum Dis. 2013 Jul;72(7):1163-9. doi: 10.1136/annrheumdis-2012-201397. Epub 2012 Sep 6.

    PubMed 22956596

  • Scire CA, Montecucco C, Codullo V, Epis O, Todoerti M, Caporali R. Ultrasonographic evaluation of joint involvement in early rheumatoid arthritis in clinical remission: power Doppler signal predicts short-term relapse. Rheumatology (Oxford). 2009 Sep;48(9):1092-7. doi: 10.1093/rheumatology/kep171. Epub 2009 Jun 26.

    PubMed 19561156

  • Saleem B, Brown AK, Quinn M, Karim Z, Hensor EM, Conaghan P, Peterfy C, Wakefield RJ, Emery P. Can flare be predicted in DMARD treated RA patients in remission, and is it important? A cohort study. Ann Rheum Dis. 2012 Aug;71(8):1316-21. doi: 10.1136/annrheumdis-2011-200548. Epub 2012 Jan 31.

    PubMed 22294638

  • Brown AK, Conaghan PG, Karim Z, Quinn MA, Ikeda K, Peterfy CG, Hensor E, Wakefield RJ, O'Connor PJ, Emery P. An explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis. Arthritis Rheum. 2008 Oct;58(10):2958-67. doi: 10.1002/art.23945.

    PubMed 18821687

  • Singh JA, Saag KG, Bridges SL Jr, Akl EA, Bannuru RR, Sullivan MC, Vaysbrot E, McNaughton C, Osani M, Shmerling RH, Curtis JR, Furst DE, Parks D, Kavanaugh A, O'Dell J, King C, Leong A, Matteson EL, Schousboe JT, Drevlow B, Ginsberg S, Grober J, St Clair EW, Tindall E, Miller AS, McAlindon T. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2016 Jan;68(1):1-26. doi: 10.1002/art.39480. Epub 2015 Nov 6.

    PubMed 26545940

  • Fransen J, Langenegger T, Michel BA, Stucki G. Feasibility and validity of the RADAI, a self-administered rheumatoid arthritis disease activity index. Rheumatology (Oxford). 2000 Mar;39(3):321-7. doi: 10.1093/rheumatology/39.3.321.

    PubMed 10788543

Questions about this trial

What is this clinical trial studying?

A study testing MusculoSkeletal Ultrasound in people with Rheumatoid Arthritis and Patient Reported Outcomes, run by Clínica de Artritis Temprana at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline of the Patient Reported Outcome (HAQ) (time frame: From baseline at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228342, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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