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T-cell Co-stimulation Modulator
Abatacept vs Adalimumab for Rheumatoid Arthritis
Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and positive for rheumatoid factor (RF) according to central lab testing during screening
Must not have
History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)
At risk for tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29, 57, 85, 113, 141, 169
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will compare the effectiveness of two different drugs for people with early rheumatoid arthritis who haven't responded well to methotrexate.
Who is the study for?
Adults with early rheumatoid arthritis (RA) that began within the last year, who have not responded well to methotrexate alone. Participants must not have used other RA drugs or treatments and should test positive for specific RA markers. They need at least 3 tender and swollen joints and a certain level of disease activity.
What is being tested?
The trial is testing if abatacept is more effective than adalimumab when both are taken with methotrexate in adults with early, seropositive RA who haven't had a good response to methotrexate alone. Patients will be randomly assigned to receive either abatacept or adalimumab.
What are the potential side effects?
Possible side effects include injection site reactions, increased risk of infections, headaches, nausea, and potentially serious allergic reactions. Both medications can affect the immune system's ability to fight off infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken any RA drugs except for methotrexate.
Select...
My tests show high levels of Anti-CCP-2 and positive for rheumatoid factor.
Select...
My rheumatoid arthritis symptoms started less than a year ago.
Select...
I have at least 3 tender and 3 swollen joints now and when first checked.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had an inflammatory joint disease that is not rheumatoid arthritis.
Select...
I am at risk for tuberculosis.
Select...
I cannot have 5 or more of my joints checked for pain or swelling.
Select...
I have an autoimmune disease other than rheumatoid arthritis or active fibromyalgia.
Select...
I have a history of ongoing or repeated bacterial infections.
Select...
I have or had a condition that affects the protective covering of my nerves.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 29, 57, 85, 113, 141, 169
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29, 57, 85, 113, 141, 169
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of SE+ Participants Meeting 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 24
Secondary study objectives
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) Over Time for SE+ Participants
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for All Participants
Adjusted Mean Change From Baseline in 36-item Short Form Survey (SF-36) at Week 104 for SE+ Participants
+31 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%
WEIGHT INCREASED
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
MUSCLE SPASMS
12%
SINUSITIS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
PARAESTHESIA
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
SWELLING
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHEUMATOID ARTHRITIS
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
ORAL CANDIDIASIS
6%
STAPHYLOCOCCAL INFECTION
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
PATELLA FRACTURE
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
LIGAMENT RUPTURE
6%
PNEUMONIA BACTERIAL
6%
PERIPHERAL SWELLING
6%
FEMUR FRACTURE
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
INFECTIOUS PLEURAL EFFUSION
6%
OSTEOARTHRITIS
6%
ACUTE KIDNEY INJURY
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
SEBORRHOEIC KERATOSIS
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
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/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)Experimental Treatment3 Interventions
Group II: Arm 1: Abatacept + MethotrexateExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abatacept
2005
Completed Phase 4
~112250
Adalimumab
2013
Completed Phase 4
~7950
Methotrexate
2019
Completed Phase 4
~4400
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,681 Previous Clinical Trials
4,124,675 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,213 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had an inflammatory joint disease that is not rheumatoid arthritis.I am at risk for tuberculosis.I haven't taken any RA drugs except for methotrexate.I cannot have 5 or more of my joints checked for pain or swelling.I have an autoimmune disease other than rheumatoid arthritis or active fibromyalgia.I have a history of ongoing or repeated bacterial infections.I have or had a condition that affects the protective covering of my nerves.My tests show high levels of Anti-CCP-2 and positive for rheumatoid factor.I have had a recent infection.My rheumatoid arthritis symptoms started less than a year ago.I have been on a stable dose of MTX for at least 4 weeks.I have at least 3 tender and 3 swollen joints now and when first checked.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Abatacept + Methotrexate
- Group 2: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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