CClinicalTrials.gg
CompletedNCT03228342ULTRAPROUpdated Jan 30, 2019

Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

An interventional study of MusculoSkeletal Ultrasound and MusculoSkeletal Ultrasound in Rheumatoid Arthritis, Patient Reported Outcomes and Musculoskeletal Ultrasound, sponsored by Clínica de Artritis Temprana. Completed at 1 site in Mexico. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by Clínica de Artritis Temprana · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Rheumatoid Arthritis
  • Patient Reported Outcomes
  • Musculoskeletal Ultrasound

Keywords

  • Rheumatoid Arthritis
  • Ultrasound
  • Impact
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 94 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

This is the only study on the registry with Clínica de Artritis Temprana as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \<16 years old.
  • Patient with recent trauma in the evaluated joints.
  • Luxation in the MCP, PIP or MTP joints.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    Ultrasound shared

    Patient will be assessed with ultrasound (GUS-7 score)

    Diagnostic Test: MusculoSkeletal Ultrasound

  • Experimental
    Ultrasound not shared

    Patient will be assessed with ultrasound (GUS-7 score)

    Diagnostic Test: MusculoSkeletal Ultrasound

Interventions

  • Diagnostic testMusculoSkeletal Ultrasound

    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.

  • Diagnostic testMusculoSkeletal Ultrasound

    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.

06

What researchers measure

Primary outcomes

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

    Minimal Clinically Significant change in HAQ

    Time frame: From baseline at 6 months

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

    Minimal Clinically Significant change in RADAI

    Time frame: from baseline at 6 months

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

    Minimal Clinically Significant change in SF-36

    Time frame: from baseline at 6 months

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

    Minimal Clinically Significant change in VAS-Patient

    Time frame: from baseline at 6 months

Secondary outcomes

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

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

    Time frame: 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.

    Time frame: baseline and 6 months

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

    Minimal Clinically Significant change in HAQ

    Time frame: from baseline at 12 months

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

    Minimal Clinically Significant change in RADAI

    Time frame: from baseline at 12 months

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

    Minimal Clinically Significant change in SF-36

    Time frame: from baseline at 12 months

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

    Minimal Clinically Significant change in VAS-Patient

    Time frame: from baseline at 12 months

07

Study locations

1 site
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
    Mexico City, 14000, Mexico
08

References and documents

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 ↗
  • El Miedany Y, El Gaafary M, Palmer D. Assessment of the utility of visual feedback in the treatment of early rheumatoid arthritis patients: a pilot study. Rheumatol Int. 2012 Oct;32(10):3061-8. doi: 10.1007/s00296-011-2098-1. Epub 2011 Sep 11. PubMed 21909946 ↗
  • Wolfe F, Pincus T. Listening to the patient: a practical guide to self-report questionnaires in clinical care. Arthritis Rheum. 1999 Sep;42(9):1797-808. doi: 10.1002/1529-0131(199909)42:93.0.CO;2-Q. No abstract available. PubMed 10513792 ↗
  • Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE Jr. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. 2000 Jul;43(7):1478-87. doi: 10.1002/1529-0131(200007)43:73.0.CO;2-M. PubMed 10902749 ↗
  • Anderson JK, Zimmerman L, Caplan L, Michaud K. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S14-36. doi: 10.1002/acr.20621. No abstract available. PubMed 22588741 ↗
  • Lillegraven S, Prince FH, Shadick NA, Bykerk VP, Lu B, Frits ML, Iannaccone CK, Kvien TK, Haavardsholm EA, Weinblatt ME, Solomon DH. Remission and radiographic outcome in rheumatoid arthritis: application of the 2011 ACR/EULAR remission criteria in an observational cohort. Ann Rheum Dis. 2012 May;71(5):681-6. doi: 10.1136/ard.2011.154625. Epub 2011 Oct 12. PubMed 21994234 ↗
  • Fransen J, van Riel PL. Outcome measures in inflammatory rheumatic diseases. Arthritis Res Ther. 2009;11(5):244. doi: 10.1186/ar2745. Epub 2009 Oct 14. PubMed 19849821 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03228342
Lead sponsor
Clínica de Artritis Temprana
Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Responsible party
Sponsor
First posted
Jul 24, 2017
Start date
May 3, 2017
Primary completion
Jan 28, 2019
Completion
Jan 28, 2019
Last update
Jan 30, 2019

Study contacts

Virginia Pascual, MD
study director · INCMNSZ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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