Ultrasound Impact in Rheumatoid Arthritis Patient Reported Outcomes

Rheumatoid Arthritis Clinical Trial

— ULTRAPRO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228342
• Other study ID #: IRE-2218-17/19-1
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: January 28, 2019

Study information

• Verified date: January 2019
• Source: Clínica de Artritis Temprana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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:

• <16 years old.

• Patient with recent trauma in the evaluated joints.

• Luxation in the MCP, PIP or MTP joints.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Musculoskeletal Ultrasound
• Patient Reported Outcomes
• Rheumatoid Arthritis

Intervention

Diagnostic Test:
• MusculoSkeletal 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.
• MusculoSkeletal 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Clínica de Artritis Temprana	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (21)

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. Review. — View Citation

Backhaus M, Ohrndorf S, Kellner H, Strunk J, Backhaus TM, Hartung W, Sattler H, Albrecht K, Kaufmann J, Becker K, Sörensen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2011 Sep 11. — View Citation

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. — View Citation

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. Review. — View Citation

Galicia-Hernández G, Parra-Salcedo F, Ugarte-Martínez P, Contreras-Yáñez I, Ponce-de-León 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Scirè 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. — View Citation

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. Review. — View Citation

Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, Kvien TK, Navarro-Compán 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, Östör 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline of the Patient Reported Outcome (HAQ)	Minimal Clinically Significant change in HAQ	From baseline at 6 months
Primary	Change from Baseline of the Patient Reported Outcome (RADAI)	Minimal Clinically Significant change in RADAI	from baseline at 6 months
Primary	Change from Baseline of the Patient Reported Outcome (SF-36)	Minimal Clinically Significant change in SF-36	from baseline at 6 months
Primary	Change from Baseline of the Patient Reported Outcome (VAS-Patient)	Minimal Clinically Significant change in VAS-Patient	from baseline at 6 months
Secondary	Ultrasound findings in Rheumatoid Arthritis Patients Classified in Remission/Low Disease Activity	Describe ultrasound findings at the moment of inclusion in the study.	Baseline
Secondary	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.	baseline and 6 months
Secondary	Change from Baseline of the Patient Reported Outcome (HAQ)	Minimal Clinically Significant change in HAQ	from baseline at 12 months
Secondary	Change from Baseline of the Patient Reported Outcome (RADAI)	Minimal Clinically Significant change in RADAI	from baseline at 12 months
Secondary	Change from Baseline of the Patient Reported Outcome (SF-36)	Minimal Clinically Significant change in SF-36	from baseline at 12 months
Secondary	Change from Baseline of the Patient Reported Outcome (VAS-Patient)	Minimal Clinically Significant change in VAS-Patient	from baseline at 12 months