487 Participants Needed
AbbVie logo

Upadacitinib vs Adalimumab for Rheumatoid Arthritis

(SELECT- SWITCH Trial)

Recruiting in Middleburg Heights (>99 mi)
+294 other locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AbbVie
Must be taking: Methotrexate
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stay on a stable dose of methotrexate (MTX) throughout the study. The protocol does not specify if you need to stop other medications, but you must have been treated with a TNF inhibitor for at least 3 months before joining.

Is Upadacitinib safe for humans?

Upadacitinib has been shown to be generally safe in humans, but it may increase the risk of serious infections, herpes zoster (shingles), and elevated creatine phosphokinase levels. These risks are similar to those of other treatments like methotrexate and adalimumab, and its safety continues to be monitored in long-term studies.12345

How does the drug upadacitinib differ from other treatments for rheumatoid arthritis?

Upadacitinib is unique because it is an oral medication that works by inhibiting Janus kinase 1 (JAK-1), a protein involved in inflammation, and has shown superior effectiveness compared to adalimumab when used with methotrexate in patients with rheumatoid arthritis who do not respond well to methotrexate alone.24678

What data supports the effectiveness of the drug Upadacitinib for treating rheumatoid arthritis?

Research shows that Upadacitinib, a drug taken by mouth, helps improve how patients with rheumatoid arthritis feel and function, especially when other treatments haven't worked well. It has been approved for use in the USA based on positive results from large studies.29101112

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
See 2 more

Exclusion Criteria

I have previously taken medication that targets JAK enzymes.
I have previously taken adalimumab.
I have previously used a non-TNFi biologic drug for my rheumatic disease.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either oral upadacitinib once daily and matching adalimumab placebo every other week, or subcutaneous adalimumab every other week and matching upadacitinib placebo once daily

12 weeks
Regular visits at a hospital or clinic

Treatment Period 2

Eligible participants continue to receive the same study treatment as assigned in Period 1

12 weeks
Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Adalimumab
  • Upadacitinib
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Upadacitinib+ Adalimumab matching PlaceboExperimental Treatment2 Interventions
Group II: Adalimumab + Upadacitinib matching PlaceboExperimental Treatment2 Interventions

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Humira for:
🇺🇸
Approved in United States as Humira for:
🇨🇦
Approved in Canada as Humira for:
🇯🇵
Approved in Japan as Humira for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a 48-week study involving patients with rheumatoid arthritis who did not respond adequately to methotrexate, upadacitinib showed significant improvements in patient-reported outcomes compared to placebo and was at least as effective as adalimumab.
Patients treated with upadacitinib reported greater reductions in pain, disability, and stiffness, with more individuals achieving clinically meaningful improvements across various measures compared to those on adalimumab.
Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE.Strand, V., Tundia, N., Bergman, M., et al.[2022]
In a phase 3 trial involving patients with psoriatic arthritis who did not respond to previous treatments, upadacitinib showed significant improvements in patient-reported outcomes (PROs) compared to placebo and was as effective as adalimumab, particularly in measures like the Health Assessment Questionnaire Disability Index (HAQ-DI) and the SF-36 Physical Component Summary score.
Patients treated with upadacitinib experienced rapid improvements in symptoms as early as week 2, with sustained benefits observed through week 56, indicating its efficacy in enhancing quality of life for those with psoriatic arthritis.
Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1.Strand, V., Mease, PJ., Soriano, ER., et al.[2022]
Upadacitinib, an oral JAK-1 inhibitor, received marketing approval in the USA in August 2019 for treating moderately to severely active rheumatoid arthritis after showing positive results in multinational phase III trials.
The approval was specifically for patients who had an inadequate response or intolerance to methotrexate, highlighting its role as an effective alternative treatment option.
Upadacitinib: First Approval.Duggan, S., Keam, SJ.[2020]

Citations

Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. [2022]
Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. [2022]
Upadacitinib: First Approval. [2020]
Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. [2023]
Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. [2021]
Upadacitinib in Rheumatoid Arthritis: A Benefit-Risk Assessment Across a Phase III Program. [2022]
Comparison of the efficacy and safety of tofacitinib and upadacitinib in patients with active rheumatoid arthritis: A Bayesian network meta-analysis of randomized controlled trials. [2020]
Upadacitinib versus placebo or adalimumab with background methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate: a subgroup analysis of a phase III randomized controlled trial in Central and Eastern European patients. [2022]
Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. [2020]
Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response. [2020]
Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial. [2020]
Long-term safety and efficacy of upadacitinib or adalimumab in patients with rheumatoid arthritis: results through 3 years from the SELECT-COMPARE study. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security