1629 Participants Needed

Upadacitinib for Rheumatoid Arthritis

(SELECT-COMPARE Trial)

Recruiting at 369 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AbbVie
Must be taking: Methotrexate
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
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

Will I have to stop taking my current medications?

You will need to stop taking all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) except for methotrexate (MTX). If you have been on a biological disease-modifying anti-rheumatic drug (bDMARD), a washout period (time without taking certain medications) is required.

Is upadacitinib safe for humans?

Upadacitinib has a generally good safety profile but may increase the risk of herpes zoster (shingles) and should not be used with certain other medications. It is not recommended for people with active tuberculosis, serious infections, active cancer, or severe liver problems. Safety monitoring continues in long-term studies.12345

How is the drug Upadacitinib different from other rheumatoid arthritis treatments?

Upadacitinib is unique because it is an oral medication that selectively inhibits Janus kinase 1 (JAK-1), which helps reduce inflammation in rheumatoid arthritis. It has shown superior effectiveness compared to some other treatments like adalimumab and abatacept, especially in patients who did not respond well to methotrexate or other biologic drugs.13678

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

Upadacitinib has shown positive results in phase III trials for treating rheumatoid arthritis, leading to its approval in the USA for patients who do not respond well to methotrexate. It has demonstrated efficacy in improving patient-reported outcomes compared to placebo and adalimumab.1891011

Who Is on the Research Team?

AI

AbbVie Inc.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with moderately to severely active rheumatoid arthritis who have been on a stable dose of methotrexate but haven't responded well to it. Participants must have at least 6 swollen and tender joints, evidence of bone erosion or positive RA markers, and may have had limited exposure to one other RA drug (not adalimumab). Those with other joint diseases or previous JAK inhibitor use are excluded.

Inclusion Criteria

I have 6 or more swollen and tender joints.
I have tried only one bDMARD (not adalimumab) for my condition and either couldn't tolerate it or used it for less than 3 months.
I have stopped taking all rheumatic disease drugs except for methotrexate.
See 3 more

Exclusion Criteria

I have previously taken JAK inhibitor medications.
I have tried adalimumab or similar medications without enough improvement.
I have a history of joint disease, but not RA. Secondary Sjogren's Syndrome is okay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive randomized treatment with upadacitinib, placebo, or adalimumab for up to 48 weeks, with potential switches based on response criteria

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension

Participants continue study treatment as assigned at the end of Period 1 for up to 5 years, with ongoing assessment of joint improvement

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Adalimumab
  • Placebo for Adalimumab
  • Placebo for Upadacitinib
  • Upadacitinib
Trial Overview The trial is testing the effectiveness and safety of Upadacitinib compared to a placebo and Adalimumab in adults with rheumatoid arthritis. All participants are already taking Methotrexate. The goal is to see if Upadacitinib can better reduce joint inflammation and prevent further damage.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: UpadacitinibExperimental Treatment3 Interventions
Group II: AdalimumabActive Control3 Interventions
Group III: Placebo followed by ABT-494Placebo Group3 Interventions

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

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Approved in European Union as Rinvoq for:
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Approved in United States as Rinvoq for:
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Approved in Canada as Rinvoq 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

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]
In a study involving 661 patients with rheumatoid arthritis (RA) who did not respond adequately to conventional DMARDs, upadacitinib (15 mg and 30 mg) significantly improved patient-reported outcomes such as pain, physical function, and overall disease activity after 12 weeks compared to placebo.
Patients taking upadacitinib reported clinically meaningful improvements in various measures, with the number needed to treat (NNT) for these benefits ranging from 4 to 8, indicating that a small number of patients need to be treated for one to experience significant improvement.
Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT.Strand, V., Pope, J., Tundia, N., et al.[2021]
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]

Citations

Upadacitinib: First Approval. [2020]
The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. [2022]
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 improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE. [2022]
Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis. [2022]
Upadacitinib tartrate in rheumatoid arthritis. [2021]
Upadacitinib for Patients with Rheumatoid Arthritis: A Comprehensive Review. [2023]
Upadacitinib in Rheumatoid Arthritis: A Benefit-Risk Assessment Across a Phase III Program. [2022]
Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. [2023]
Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. [2021]
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