Study | Research Studies | School of Medicine

A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Primary Objective

For Period 1, the primary objective is to evaluate the efficacy and safety of upadacitinib and adalimumab, in adult subjects on background MTX, following an inadequate response or intolerance to a single TNFi. For Period 2, the objective is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib and adalimumab in subjects who have completed Period 1.

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Description

This is a Phase 3b/4 multicenter study that includes 2 periods. Period 1 is a 12-week randomized, double-blind, double-dummy, active comparator-controlled period designed to compare the efficacy and safety of upadacitinib (15 mg QD) + MTX versus dalimumab (40 mg eow) + MTX in adult subjects with moderately to severely active RA following an inadequate response or intolerance to a single TNFi. Period 2 is a 36-week blinded extension period to evaluate the safety, tolerability, and efficacy of upadacitinib 15 mg QD+ MTX, or adalimumab 40 mg eow+ MTX, in subjects with RA who have completed Period 1.

Details

Age

Adult

Eligibility

 Diagnosis of RA for ≥ 3 months prior to screening based on the 2010 ACR/EULAR classification criteria for RA.  Subjects have been treated for ≥ 3 consecutive months prior to screening with 1 TNFi (originator or biosimilar) for RA (except adalimumab [originator or biosimilar]), but continue to exhibit active RA, or had to discontinue due to intolerability, irrespective of treatment duration. Up to 15% of subjects who were intolerant to 1 TNFi will be allowed to enroll.Subjects must have been on oral or parenteral MTX therapy ≥ 3 months and on a stable prescription of 15 to 25 mg/week (or ≥ 10 mg/week in subjects intolerant of MTX at doses ≥ 15 mg/week) for ≥ 4 weeks prior to the first dose of study drug. In addition, all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.  Additional local requirements for MTX may apply.  Subject meets both of the following disease activity criteria:  ≥ 6 swollen joint (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline;  hsCRP ≥ 3 mg/L (central lab, ULN 2.87 mg/L) at screening.

Locations

Barbara Davis Center
University of Colorado Hospital

Principal Investigator

Elena Weinstein

Study ID

Protocol Number: 23-1332

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