Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

Aletaha, D.; Landewe, R.; Karonitsch, T.; Bathon, J.; Boers, M.; Bombardier, C.; Bombardieri, S.; Choi, H.; Combe, B.; Dougados, M.; Emery, P.; Gomez‐Reino, J.; Keystone, E.; Koch, G.; Kvien, T. K.; Martin‐Mola, E.; Matucci‐Cerinic, M.; Michaud, K.; O'dell, J.; Paulus, H.; Pincus, T.; Richards, P.; Simon, L.; Siegel, J.; Smolen, J. S.; Sokka, T.; Strand, V.; Tugwell, P.; van der Heijde, D.; van Riel, P.; Vlad, S.; van Vollenhoven, R.; Ward, M.; Weinblatt, M.; Wells, G.; White, B.; Wolfe, F.; Zhang, B.; Zink, A.; Felson, D.

doi:10.1002/art.24123

Cited by 214Rheumatoid Arthritis Research and TherapiesStatistical Methods in Clinical TrialsMeta-analysis and systematic reviews

The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.

Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

Aletaha, D., Landewe, R., Karonitsch, T., Bathon, J., Boers, M., Bombardier, C., Bombardieri, S., Choi, H., Combe, B., Dougados, M., Emery, P., Gomez‐Reino, J., Keystone, E., Koch, G., Kvien, T. K., Martin‐Mola, E., Matucci‐Cerinic, M., Michaud, K., O'dell, J., Paulus, H., Pincus, T., Richards, P., Simon, L., Siegel, J., Smolen, J. S., Sokka, T., Strand, V., Tugwell, P., van der Heijde, D., van Riel, P., Vlad, S., van Vollenhoven, R., Ward, M., Weinblatt, M., Wells, G., White, B., Wolfe, F., Zhang, B., Zink, A., Felson, D.·2008·Arthritis Care & Research

DOI 10.1002/art.24123

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Abstract

Objective: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods: The project followed the EULAR standardized operating procedures, which use a three‐step approach: 1) expert‐based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). Results: Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue. Conclusion: These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta‐analyses.

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Clinical parameters recorded did not include all core set measures as per EULAR/ACR collaborative recommendations for reporting disease activity in rheumatoid arthritis clinical trials.
“and clinical parameters recorded did not include all the core set measures as per the EULAR/ACR collaborative recommendations for reporting disease activity in clinical trials of patients with RA.59”
From Diurnal production of cortisol and prediction of treatment response in rheumatoid arthritis: a 6-month, real-life prospective cohort study (2024) · cites this paper as [59]

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Authors: Aletaha, D., Landewe, R., Karonitsch, T., Bathon, J., Boers, M., Bombardier, C., Bombardieri, S., Choi, H., Combe, B., Dougados, M., Emery, P., Gomez‐Reino, J., Keystone, E., Koch, G., Kvien, T. K., Martin‐Mola, E., Matucci‐Cerinic, M., Michaud, K., O'dell, J., Paulus, H., Pincus, T., Richards, P., Simon, L., Siegel, J., Smolen, J. S., Sokka, T., Strand, V., Tugwell, P., van der Heijde, D., van Riel, P., Vlad, S., van Vollenhoven, R., Ward, M., Weinblatt, M., Wells, G., White, B., Wolfe, F., Zhang, B., Zink, A., & Felson, D.
Affiliations: Medical University of Vienna (AT)
Johns Hopkins University (US)
Vrije Universiteit Amsterdam (NL)
Institute for Work & Health (CA)
University of Pisa (IT)
University of British Columbia (CA)
Centre Hospitalier Universitaire de Montpellier (FR)
Université Paris Descartes (FR)
University of Leeds (GB)
University of Toronto (CA)
University of North Carolina at Chapel Hill (US)
Diakonhjemmet Hospital (NO)
University of Florence (IT)
University of California, Los Angeles (US)
New York University (US)
University of Bristol (GB)
Harvard University (US)
United States Food and Drug Administration (US)
Central Finland Health Care District (FI)
Stanford University (US)
Leiden University (NL)
Radboud University Nijmegen (NL)
Boston University (US)
Karolinska Institutet (SE)
National Institutes of Health (US)
University of Ottawa (CA)
Arthritis Foundation (US)
Charité – Universitätsmedizin Berlin (DE)
ORCID: Aletaha, D.
Karonitsch, T.
Bathon, J.
Boers, M.
Bombardier, C.
Bombardieri, S.
Choi, H.
Combe, B.
Dougados, M.
Emery, P.
Keystone, E.
Matucci‐Cerinic, M.
Michaud, K.
Pincus, T.
Simon, L.
Smolen, J. S.
Sokka, T.
Strand, V.
Tugwell, P.
van der Heijde, D.
van Riel, P.
van Vollenhoven, R.
Ward, M.
Weinblatt, M.
Wells, G.
White, B.
Zink, A.
Felson, D.
Venue: Arthritis Care & Research
Publisher: Wiley
Published: 2008-09-29
Volume: 59
Issue: 10
Pages: 1371-1377
ISSN: 0893-7524 (ISSN-L)
1529-0123
DOI: 10.1002/art.24123
OpenAlex: W2099680326
Cited by: 214
References: 17
Citations by year: 2026: 1 · 2025: 1 · 2024: 5 · 2023: 8 · 2022: 10 · 2021: 16 · 2020: 11 · 2019: 14 · 2018: 15 · 2017: 13 · 2016: 15 · 2015: 16 · 2014: 10 · 2013: 14 · 2012: 17
FWCI: 10.88
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Arthritis Care & Research (publishedVersion)
PubMed (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
Florence Research (University of Florence) (submittedVersion)
Radboud Repository (Radboud University) (submittedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: Versus Arthritis (18475)
Topics: Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: rheumatoid arthritis, disease activity, clinical trial reporting, reporting guidelines, low disease activity, remission, fatigue, outcome harmonization
MeSH terms: Arthritis, Rheumatoid, Clinical Trials as Topic, Cooperative Behavior, Humans, Antirheumatic Agents, Evidence-Based Medicine

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Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

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