A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol

Arthritis & Rheumatology
J R CurtisYusuf Yazici

Abstract

The aim of the Patient/Physician Reported Efficacy Determination In Clinical Practice Trial (PREDICT; ClinicalTrials identifier NCT01255761) was to compare the patient-reported Routine Assessment of Patient Index Data 3 (RAPID-3) instrument with the investigator-based Clinical Disease Activity Index (CDAI) for assessing certolizumab pegol (CZP) treatment response in rheumatoid arthritis patients at 12 weeks and to predict the treatment response at week 52 using the data from week 12 (coprimary end points). Patients received 400 mg of CZP at weeks 0, 2, and 4 (loading dose), followed by 200 mg every 2 weeks thereafter. Patients were randomized 1:1 to assessment with the RAPID-3 or the CDAI. Responder classification was performed at week 12; treatment response was defined as a score of ≤6 or a 20% improvement over baseline on the RAPID-3 or a score of ≤10 or a 20% improvement over baseline on the CDAI. Long-term treatment success was defined as a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) of ≤3.2 at week 52. Comparisons were made for the coprimary end points using noninferiority methods. Patients with improvement of <1 on the CDAI score or with no improvement on the RAPID-3 score at w...Continue Reading

References

Aug 7, 2007·Best Practice & Research. Clinical Rheumatology·Daniel Aletaha, Josef S Smolen
Dec 19, 2012·Rheumatology·Kathryn F Hobbs, Marc D Cohen
May 15, 2013·Journal of Clinical Rheumatology : Practical Reports on Rheumatic & Musculoskeletal Diseases·Isabel CastrejónTheodore Pincus

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Citations

Apr 3, 2016·Annals of the Rheumatic Diseases·Josef S SmolenUNKNOWN European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)
Sep 9, 2017·The Cochrane Database of Systematic Reviews·Vicente Ruiz GarciaJosé A Bernal
Oct 13, 2018·British Journal of Pharmacology·Christopher Schultz
Nov 18, 2018·The Journal of Rheumatology·Jeffrey R CurtisLang Chen
Oct 23, 2020·Arthritis Care & Research·Tate M JohnsonBryant R England

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Clinical Trials Mentioned

NCT01255761

Software Mentioned

RAPID

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