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Disease-Modifying Anti-Rheumatic Drug (DMARD)
Upadacitinib for Rheumatoid Arthritis
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14
Awards & highlights
Study Summary
This study is evaluating whether a drug called upadacitinib can help people with rheumatoid arthritis.
Eligible Conditions
- Rheumatoid Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
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 Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14
Secondary outcome measures
Change From Baseline in Duration of Morning Stiffness at Week 14
Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14
+4 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
Trial Design
4Treatment groups
Experimental Treatment
Group I: Upadacitinib 30 mgExperimental Treatment2 Interventions
Period 1: Participants receive upadacitnib 30 mg once daily and placebo to methotrexate once weekly for 14 weeks.
Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Group II: Upadacitinib 15 mgExperimental Treatment2 Interventions
Period 1: Participants receive upadacitnib 15 mg once daily and placebo to methotrexate once weekly for 14 weeks.
Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Group III: Methotrexate / Upadacitinib 30 mgExperimental Treatment4 Interventions
Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib once daily for 14 weeks.
Period 2: Participants receive upadacitinib 30 mg once daily until implementation of Protocol Amendment 5 when participants begin to receive upadacitinib 15 mg once daily up to Week 260.
Group IV: Methotrexate / Upadacitinib 15 mgExperimental Treatment4 Interventions
Period 1: Participants receive methotrexate once weekly and placebo to upadacitinib for 14 weeks.
Period 2: Participants receive upadacitinib 15 mg once daily up to Week 260.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved
Methotrexate
FDA approved
Placebo Upadacitinib
2016
Completed Phase 3
~650
Placebo Methotrexate
2014
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
500,396 Total Patients Enrolled
48 Trials studying Rheumatoid Arthritis
112,972 Patients Enrolled for Rheumatoid Arthritis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
100,909 Total Patients Enrolled
24 Trials studying Rheumatoid Arthritis
17,553 Patients Enrolled for Rheumatoid Arthritis
Frequently Asked Questions
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