title: Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.
abstract: OBJECTIVE
  Rheumatoid arthritis (RA) clinical trials often exclude patients who have low C-reactive protein (CRP) levels, which slows enrollment into the trial. The purpose of this study was to determine whether high Multi-Biomarker Disease Activity (MBDA) scores (>44) in RA patients with low CRP levels (≤10 mg/liter) could be used as a complement to CRP levels >10 mg/liter to enhance patient recruitment without affecting clinical trial outcomes.
  
  
  METHODS
  We evaluated patients from the Swedish Pharmacotherapy (SWEFOT) trial, which did not include any selection criteria for CRP levels. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy in MTX-naive RA patients (n = 220) and after 3-10 months of add-on therapy in patients who were incomplete responders to MTX alone (MTX-IR) (n = 127). Radiographic outcomes were assessed at 1 year in all patients. Within each cohort, the outcomes were compared between patients with a CRP level of ≤10 mg/liter and an MBDA score of >44 at the start of the respective treatment interval versus those with a CRP level of >10 mg/liter.
  
  
  RESULTS
  Patients with both a CRP level of ≤10 mg/liter and an MBDA score of >44 at baseline had clinical and radiographic outcomes that were comparable to those in patients with a CRP level of >10 mg/liter at baseline. This broadened definition of the inclusion criteria identified an additional 24% of patients in the MTX-naive cohort and 47% in the MTX-IR cohort.
  
  
  CONCLUSIONS
  Patient recruitment into RA clinical trials may be substantially enhanced, without any decrease in clinical and radiographic outcomes, by using as an inclusion criterion "a CRP level of >10 mg/liter and/or an MBDA score of >44."
authors.affiliation: Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.affiliation: Rebecca Bolce, MSN, Eric H. Sasso, MD, C. C. Hwang, PhD, Oscar G. Segurado, MD, PhD: Crescendo Bioscience, Inc., South San Francisco, California.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Bolce
authors.affiliation: Lund University, Lund, Sweden.
authors.forename: Karen
authors.initials: K
authors.lastname: Hambardzumyan
authors.affiliation: Karolinska Institute and Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Saedis
authors.initials: S
authors.lastname: Saevarsdottir
authors.affiliation: Lund University, Lund, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Forslind
authors.affiliation: Lund University, Lund, Sweden.
authors.forename: Ingemar F
authors.initials: IF
authors.lastname: Petersson
authors.affiliation: Rebecca Bolce, MSN, Eric H. Sasso, MD, C. C. Hwang, PhD, Oscar G. Segurado, MD, PhD: Crescendo Bioscience, Inc., South San Francisco, California.
authors.forename: Eric H
authors.initials: EH
authors.lastname: Sasso
authors.affiliation: Rebecca Bolce, MSN, Eric H. Sasso, MD, C. C. Hwang, PhD, Oscar G. Segurado, MD, PhD: Crescendo Bioscience, Inc., South San Francisco, California.
authors.forename: C C
authors.initials: CC
authors.lastname: Hwang
authors.affiliation: Rebecca Bolce, MSN, Eric H. Sasso, MD, C. C. Hwang, PhD, Oscar G. Segurado, MD, PhD: Crescendo Bioscience, Inc., South San Francisco, California.
authors.forename: Oscar G
authors.initials: OG
authors.lastname: Segurado
authors.affiliation: Lund University, Lund, Sweden.
authors.forename: Pierre
authors.initials: P
authors.lastname: Geborek
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D018579:Patient Selection; D012720:Severity of Illness Index
chemical_list: D018501:Antirheumatic Agents; D008727:Methotrexate