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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)
Must not have
Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 26
Awards & highlights
Pivotal 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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously taken JAK inhibitor medications.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Rheumatoid Factor
Secondary study objectives
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 • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
INFLUENZA
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
WEIGHT INCREASED
12%
FALL
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
OROPHARYNGEAL PAIN
6%
SEBORRHOEIC KERATOSIS
6%
HEADACHE
6%
NAUSEA
6%
HIP FRACTURE
6%
PHARYNGITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
HYPOKALAEMIA
6%
SJOGREN'S SYNDROME
6%
RHINORRHOEA
6%
PNEUMONIA BACTERIAL
6%
ASTHMA
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
CONSTIPATION
6%
HYPONATRAEMIA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
PHOTODERMATOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HAEMOGLOBIN DECREASED
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
FEELING HOT
6%
COSTOCHONDRITIS
6%
LEUKOCYTOSIS
6%
TACHYCARDIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CHEST PAIN
6%
FATIGUE
6%
CANDIDA INFECTION
6%
SKIN LACERATION
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
OSTEOARTHRITIS
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
BACK PAIN
6%
DIZZINESS
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
OSTEOPENIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~11250
Placebo for Adalimumab
2018
Completed Phase 3
~390
Adalimumab
2013
Completed Phase 4
~7950
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
521,950 Total Patients Enrolled
48 Trials studying Rheumatoid Arthritis
112,058 Patients Enrolled for Rheumatoid Arthritis
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
99,990 Total Patients Enrolled
24 Trials studying Rheumatoid Arthritis
16,616 Patients Enrolled for Rheumatoid Arthritis
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Placebo followed by ABT-494
- Group 2: Adalimumab
- 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.