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Tumor Necrosis Factor (TNF) Inhibitor

Upadacitinib vs Adalimumab for Rheumatoid Arthritis (SELECT- SWITCH Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.
On oral or parenteral methotrexate (MTX) therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

SELECT- SWITCH Trial Summary

This trial will assess the safety and effectiveness of upadacitinib compared to adalimumab in treating RA when used with a stable dose of methotrexate. 480 participants will be enrolled in 250 sites across the world, and receive either upadacitinib or adalimumab randomly. Assessments and side effects will be monitored.

Who is the study for?
Adults with moderate to severe Rheumatoid Arthritis (RA) who haven't responded well or are intolerant to one TNF-inhibitor, excluding adalimumab. They must have been on a stable methotrexate dose for at least 3 months and meet specific criteria for joint swelling, tenderness, and inflammation levels. Not eligible if they've used adalimumab before, other non-TNF biologic treatments, had arthritis before age 17, or taken any JAK inhibitors.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of oral Upadacitinib against subcutaneous Adalimumab in RA patients. It's double-blinded and randomizes participants into two groups: one receives Upadacitinib with placebo injections; the other gets Adalimumab with placebo pills. The study spans across approximately 250 sites worldwide with about 480 participants.See study design
What are the potential side effects?
Potential side effects may include infection risks due to immune system suppression by both drugs, liver enzyme elevations from Upadacitinib, injection site reactions from Adalimumab, as well as gastrointestinal issues and headaches common to many RA medications.

SELECT- SWITCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Rheumatoid Arthritis for 3 months or more.
Select...
I have been on a stable methotrexate treatment for at least 3 months and take folic or folinic acid supplements.
Select...
I have 6 or more swollen and tender joints and high levels of inflammation.

SELECT- SWITCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2
Secondary outcome measures
Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Change from Baseline in Participants Assessment of Pain
+2 more

SELECT- SWITCH Trial Design

2Treatment groups
Experimental Treatment
Group I: Upadacitinib+ Adalimumab matching PlaceboExperimental Treatment2 Interventions
Participants will receive upadacitinib once a day along with matching placebo for adalimumab at eow (every other week) in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.
Group II: Adalimumab + Upadacitinib matching PlaceboExperimental Treatment2 Interventions
Participants will receive adalimumab at eow (every other week) along with matching placebo for upadacitinib once a day in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9670
Adalimumab
2013
Completed Phase 4
~6480

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
501,910 Total Patients Enrolled
48 Trials studying Rheumatoid Arthritis
113,140 Patients Enrolled for Rheumatoid Arthritis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,629 Total Patients Enrolled
10 Trials studying Rheumatoid Arthritis
8,436 Patients Enrolled for Rheumatoid Arthritis

Media Library

Adalimumab (Tumor Necrosis Factor (TNF) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05814627 — Phase 3
Rheumatoid Arthritis Research Study Groups: Adalimumab + Upadacitinib matching Placebo, Upadacitinib+ Adalimumab matching Placebo
Rheumatoid Arthritis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT05814627 — Phase 3
Adalimumab (Tumor Necrosis Factor (TNF) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814627 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications for this clinical trial being accepted at the present moment?

"Affirmative; the current data on clinicaltrials.gov divulges that recruitment for this study is ongoing, having initially been posted and updated lastly on June 15th 2023."

Answered by AI

What is the cap on patient enrollment for this experiment?

"This clinical trial needs 480 qualified participants to properly evaluate the efficacy of the drug, and can be conducted at Rheumatology Associates of Oklahoma /ID# 253994 in Oklahoma City, OK or Corporacion de Beneficiencia Osorno /ID# 252556 in Osorno, Los Lagos."

Answered by AI

Are there numerous venues where this clinical experiment is currently being conducted in the city?

"This medical study is currently being conducted in 191 different sites, ranging from Oklahoma City to Osorno and Zagreb. To reduce the burden of traveling, it's recommended that those who wish to participate choose a location close-by."

Answered by AI

To what extent might this treatment be hazardous for individuals?

"Our team has assigned a rating of 3 to the safety profile of this therapy, as it is in Phase 3 clinical trials with evidence-backed efficacy and multiple rounds validating its security."

Answered by AI

Who else is applying?

What site did they apply to?
Tekton Research, Inc. /ID# 254004
Trinity Universal Research Associates - Carrollton /ID# 254648
Clinical Research of Philadelphia, LLC /ID# 255025
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I have tried numerous drugs. I get concerned that they will greatly affect my liver. Looking forward to trying something new.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
2023. "Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05814627.
All > Montreal > Ra
~284 spots leftby Sep 2025
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