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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.
Must not have
History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).
Prior exposure to any janus kinase (JAK) inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Pivotal Trial
Summary
This trial is testing two medications, upadacitinib (a daily pill) and adalimumab (an injection), for adults with rheumatoid arthritis who haven't responded to other treatments. The study aims to see which drug is safer and more effective. Both medications work by reducing inflammation through different mechanisms in the immune system. Adalimumab, an injection, has been extensively studied and used for treating rheumatoid arthritis, showing significant improvements in patients who have not responded to other treatments.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had arthritis before I was 17 or have an inflammatory joint disease that is not RA.
Select...
I have previously taken medication that targets JAK enzymes.
Select...
I have previously taken adalimumab.
Select...
I have previously used a non-TNFi biologic drug for my rheumatic disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2
Secondary study objectives
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~11250
Adalimumab
2013
Completed Phase 4
~7950
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Rheumatoid Arthritis (RA) include methotrexate, TNF inhibitors, and Janus kinase (JAK) inhibitors like upadacitinib. Methotrexate works by inhibiting the metabolism of folic acid, which reduces inflammation and slows disease progression.
TNF inhibitors block the activity of tumor necrosis factor-alpha, a cytokine involved in systemic inflammation. JAK inhibitors, such as upadacitinib, interfere with the JAK-STAT signaling pathway, which is crucial for the inflammatory process in RA.
By targeting these pathways, these treatments help reduce inflammation, prevent joint damage, and improve overall function and quality of life for RA patients.
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review.The BeSt story: on strategy trials in rheumatoid arthritis.
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review.The BeSt story: on strategy trials in rheumatoid arthritis.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,022 Previous Clinical Trials
519,762 Total Patients Enrolled
48 Trials studying Rheumatoid Arthritis
113,207 Patients Enrolled for Rheumatoid Arthritis
ABBVIE INC.Study DirectorAbbVie
443 Previous Clinical Trials
160,185 Total Patients Enrolled
10 Trials studying Rheumatoid Arthritis
8,459 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously taken medication that targets JAK enzymes.I have 6 or more swollen and tender joints and high levels of inflammation.I have been diagnosed with Rheumatoid Arthritis for 3 months or more.I have RA and have been treated with a TNFi for 3 months or more but still have active symptoms, or I couldn't tolerate the TNFi.I have previously taken adalimumab.I have previously used a non-TNFi biologic drug for my rheumatic disease.I had arthritis before I was 17 or have an inflammatory joint disease that is not RA.I am from China, Japan, Korea, or Taiwan and take a stable dose of MTX of at least 7.5 mg/week.I have been on a stable methotrexate treatment for at least 3 months and take folic or folinic acid supplements.
Research Study Groups:
This trial has the following groups:- Group 1: Adalimumab + Upadacitinib matching Placebo
- Group 2: Upadacitinib+ Adalimumab matching Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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