Your session is about to expire
← Back to Search
Janus Kinase (JAK) Inhibitor
Upadacitinib for Rheumatoid Arthritis (SELECT-COMPARE Trial)
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 26
Awards & highlights
SELECT-COMPARE Trial Summary
This trial found that upadacitinib was more effective than placebo and adalimumab in adults with RA who had an inadequate response to MTX.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Upadacitinib might cause infections, headaches, nausea, high blood pressure, liver issues or blood clots. Adalimumab could lead to injection site reactions, upper respiratory infections like sinusitis or sore throat, headache, rash or gastrointestinal symptoms.
SELECT-COMPARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 6 or more swollen and tender joints.
Select...
I have stopped taking all rheumatic disease drugs except for methotrexate.
Select...
I have been diagnosed with rheumatoid arthritis for at least 3 months.
Select...
I have bone erosions and either a positive rheumatoid factor or anti-CCP antibodies.
Select...
I have been on methotrexate for over 3 months and take folic or folinic acid.
SELECT-COMPARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 26
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 Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Rheumatoid Factor
Secondary outcome measures
Change From Baseline in DAS28 (CRP) at Week 12
Change From Baseline in Duration of Morning Stiffness at Week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
+9 moreSide effects data
From 2023 Phase 3 trial • 613 Patients • NCT030863436%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg
SELECT-COMPARE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: UpadacitinibExperimental Treatment3 Interventions
Participants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were to be switched to 40 mg adalimumab eow until Week 48.
Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Group II: AdalimumabActive Control3 Interventions
Participants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index [CDAI] ≤ 10) were to be switched to 15 mg upadacitinib orally QD until Week 48.
Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Group III: Placebo followed by ABT-494Placebo Group3 Interventions
Participants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1).
Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.
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
Placebo for Adalimumab
2018
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
499,476 Total Patients Enrolled
48 Trials studying Rheumatoid Arthritis
111,991 Patients Enrolled for Rheumatoid Arthritis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
99,928 Total Patients Enrolled
24 Trials studying Rheumatoid Arthritis
16,572 Patients Enrolled for Rheumatoid Arthritis
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Adalimumab
- Group 2: Placebo followed by ABT-494
- Group 3: Upadacitinib
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other research has been conducted that is similar to Upadacitinib?
"At the moment, 69 different clinical trials are studying Upadacitinib. 26 of these studies are in Phase 3. Most of the research for Upadacitinib is based in London, but there are 5318 locations running trials for Upadacitinib worldwide."
Answered by AI
What desired outcome is this research looking to achieve?
"According to the study sponsor, AbbVie, the primary outcome being measured is the percentage of participants that have an ACR20 response at Week 12. Additionally, this trial will also collect data on secondary outcomes like the change from Baseline in DAS28 (CRP) at Week 12, Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26, and Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12."
Answered by AI
Does Upadacitinib have any dangerous side effects for patients?
"Upadacitinib has received a Phase 3 safety rating from our team, meaning that while there is some evidence of the drug's efficacy, there is also extensive data supporting its safety."
Answered by AI
Are there different research sites for this project?
"There are presently 100 locations where this study is running, some of which include Vancouver, Tupelo and Hamilton. It is crucial to pick the location nearest to you to reduce the amount of travelling required, should you enroll in the study."
Answered by AI
For what purpose is Upadacitinib most commonly prescribed?
"Upadacitinib is indicated for patients who have not responded well to other forms of treatment. Additionally, this medication can improve symptoms associated with dermatitis, atopic, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis."
Answered by AI
Who else is applying?
What state do they live in?
New York
Illinois
Texas
How old are they?
18 - 65
What site did they apply to?
T. Joseph Raoof, MD, Inc. /ID# 144884
St. Luke's Hospital /ID# 156750
Arthritis Rheumatic Back Disorder /ID# 143102
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
1
What questions have other patients asked about this trial?
How long does the entire process take? And what are the incentives?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I’ve tried 2 other drugs that haven’t worked and am on one that only pacifies.
PatientReceived 1 prior treatment
Prednisone & methotrexate were prescribed upon Dx. Not viable solutions due to sig /negative side-effects incl hair loss & osteopenia. Humira was considered, but wasn’t an option bc of potential neg side-effects.
PatientReceived no prior treatments
I was diagnosed just barely in August of this year, but since January, I have been so incredibly sick. I stay fatigued and completely ill. This disease has debilitated me and robbed me of my life. I am contacting y’all in hopes that I will be eligible for this trial in attempt to get my life back.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger