Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.
van Vollenhoven, Ronald F ; Bolce, Rebecca ; Hambardzumyan, Karen ; Saevarsdottir, Saedis ; Forslind, Kristina LU
; Petersson, Ingemar
LU
; Sasso, Eric H
; Hwang, C C
; Segurado, Oscar G
and Geborek, Pierre
LU
(2015)
In Arthritis & Rheumatology
67(11).
p.2855-2860
- Abstract
- Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were... (More)
- Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were assessed at 1 year for all patients. Within each cohort, outcomes were compared between patients with CRP ≤10 mg/L and MBDA score >44 at the start of the respective treatment interval versus those with CRP >10 mg/L. Results Patients with baseline CRP ≤10 mg/L and MBDA score >44 at baseline had comparable clinical and radiographic outcomes to those for patients with CRP>10 mg/L. This broadened definition of inclusion criteria identified an additional 24% MTX-naïve and 47% MTX-IR patients. Conclusion Patient recruitment of RA clinical trials may be substantially enhanced by using "CRP >10 mg/L and/or MBDA score >44" as an inclusion criterion, without diminishing clinical or radiographic outcomes. This article is protected by copyright. All rights reserved. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/7720639
- author
- van Vollenhoven, Ronald F
; Bolce, Rebecca
; Hambardzumyan, Karen
; Saevarsdottir, Saedis
; Forslind, Kristina
LU
; Petersson, Ingemar
LU
; Sasso, Eric H
; Hwang, C C
; Segurado, Oscar G
and Geborek, Pierre
LU
- organization
- publishing date
- 2015
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Arthritis & Rheumatology
- volume
- 67
- issue
- 11
- pages
- 2855 - 2860
- publisher
- John Wiley & Sons Inc.
- external identifiers
-
- pmid:26213309
- wos:000363881400009
- scopus:84946083507
- pmid:26213309
- ISSN
- 2326-5205
- DOI
- 10.1002/art.39274
- language
- English
- LU publication?
- yes
- id
- 6edac393-238c-40a7-ad56-4836a082ee21 (old id 7720639)
- alternative location
- http://www.ncbi.nlm.nih.gov/pubmed/26213309?dopt=Abstract
- date added to LUP
- 2016-04-01 10:59:27
- date last changed
- 2025-10-14 10:15:08
@article{6edac393-238c-40a7-ad56-4836a082ee21,
abstract = {{Objective Rheumatoid arthritis (RA) clinical trials often exclude patients with low C-reactive protein (CRP), slowing trial enrollment. We evaluated whether RA patients with a high multi-biomarker disease activity (MBDA) score (>44) among those with low CRP (≤10 mg/L) could complement patients with CRP >10mg/L to enhance patient recruitment without affecting clinical trial outcomes. Methods We evaluated patients from the Swedish pharmacotherapy (SWEFOT) trial, which had no CRP selection criteria. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy for MTX-naïve patients (N=220) and after add-on therapy from Months 3 to 12 for MTX-inadequate responder (IR) patients (N=127). Radiographic outcomes were assessed at 1 year for all patients. Within each cohort, outcomes were compared between patients with CRP ≤10 mg/L and MBDA score >44 at the start of the respective treatment interval versus those with CRP >10 mg/L. Results Patients with baseline CRP ≤10 mg/L and MBDA score >44 at baseline had comparable clinical and radiographic outcomes to those for patients with CRP>10 mg/L. This broadened definition of inclusion criteria identified an additional 24% MTX-naïve and 47% MTX-IR patients. Conclusion Patient recruitment of RA clinical trials may be substantially enhanced by using "CRP >10 mg/L and/or MBDA score >44" as an inclusion criterion, without diminishing clinical or radiographic outcomes. This article is protected by copyright. All rights reserved.}},
author = {{van Vollenhoven, Ronald F and Bolce, Rebecca and Hambardzumyan, Karen and Saevarsdottir, Saedis and Forslind, Kristina and Petersson, Ingemar and Sasso, Eric H and Hwang, C C and Segurado, Oscar G and Geborek, Pierre}},
issn = {{2326-5205}},
language = {{eng}},
number = {{11}},
pages = {{2855--2860}},
publisher = {{John Wiley & Sons Inc.}},
series = {{Arthritis & Rheumatology}},
title = {{Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.}},
url = {{https://lup.lub.lu.se/search/files/2287665/8868316}},
doi = {{10.1002/art.39274}},
volume = {{67}},
year = {{2015}},
}