Rheumatoid ArthritisPhase 4NCT02557100
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
A Phase 4 study testing Abatacept, Adalimumab and Methotrexate in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 28 sites in 3 countries.
Trial summary
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Abatacept, Adalimumab and Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 19 Nov 2015to 28 Mar 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of RA for no more than 12 months prior to enrollment
- Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA
- Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses
- At least 3 tender \& 3 swollen joints
- Anti-cyclic citrullinated peptide (CCP) > 3X the upper limit of normal and positive rheumatoid factor
Who cannot join
- History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc)
- Prior use of non-biologic therapy other than methotrexate
- Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy
- Subjects with chronic or recent acute serious infection
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
United States21 sites
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, 22205
University Of Colorado Health Sciences Center
Aurora, Colorado, 80045
University Of Alabama At Birmingham
Birmingham, Alabama, 35294-7201
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635-8406
St. Joseph Heritage Medical Group
Fullerton, California, 92835
Arizona Arthritis & Rheumatology Research PLLC
Glendale, Arizona, 85306
Aa Mrc Llc
Grand Blanc, Michigan, 48439
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, 35801
West Tennessee Research Institute
Jackson, Tennessee, 38305
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Marietta Rheumatology
Marietta, Georgia, 30060
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
Desert Medical Advances
Palm Desert, California, 92260
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, 85037
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324
Oregon Health & Science University (Ohsu)
Portland, Oregon, 97239
Clinical And Translational Research Center Of Alabama, Pc
Tuscaloosa, Alabama, 35406
Medical Faculty Associates,Inc.
Washington D.C., District of Columbia, 20037
Howard University Hospital
Washington D.C., District of Columbia, 20060
The Center For Rheumatology And Bone Research
Wheaton, Maryland, 20902
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
Canada4 sites
Institut De Rhumatologie De Montreal
Montreal, Quebec, H2L 1S6
Dr. Anil K Gupta Med Prof Corp
Toronto, Ontario, M9V 4B4
Centre De Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2
Essex County Medical Society
Windsor, Ontario, N8X 5A6
Mexico3 sites
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Mexico City, 11850
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V.
Mexico City, 06760
About this study
Official title: A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Abatacept, Adalimumab, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
AdalimumabDrug
Also called Humira
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Abatacept Single Blind Treatment Period Receives: Drug: Abatacept; Drug: Methotrexate |
| Treatment B | Active comparator | Adalimumab Single Blind Treatment Period Receives: Drug: Abatacept; Drug: Adalimumab; Drug: Methotrexate |
| Treatment C | Active comparator | Abatacept Cumulative Treatment Period Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Adverse Events (AEs)
Percentage of participants who experienced an AE
Measured: up to 85 days post last dose, approximately 40 weeks
Percentage of Participants With an Serious Adverse Events (SAEs)
Percentage of participants who experienced an SAEs
Measured: up to 85 days post last dose, approximately 40 weeks
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
Percentage of participants who experienced an (AEsDc)
Measured: up to 85 days post last dose, approximately 40 weeks
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
Percentage of participants who experienced an (SAEsDc)
Measured: up to 85 days post last dose, approximately 40 weeks
Percentage of Drug Related Adverse Events (DRAEs)
Percentage of participants who experienced an DRAEs
Measured: up to 85 days post last dose, approximately 40 weeks
Percentage of Drug Related Serious Adverse Events (DRSAEs)
Percentage of participants who experienced an DRSAEs
Measured: up to 85 days post last dose, approximately 40 weeks
Number of Deaths
Number of participants who experienced Death
Measured: up to 85 days post last dose, approximately 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start19 Nov 2015
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557100
- Sponsor's protocol ID
- IM101-567
- Status last verified
- Aug 2020
- First submitted
- 4 Sep 2015
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rigby W, Buckner JH, Louis Bridges S Jr, Nys M, Gao S, Polinsky M, Ray N, Bykerk V. HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA. Arthritis Res Ther. 2021 Sep 18;23(1):245. doi: 10.1186/s13075-021-02607-7.
PubMed 34537057
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs
- ClinicalTrials.gov ID
- NCT02557100
- Acronym / sponsor ID
- IM101-567
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Abatacept, Drug: MethotrexateAbatacept Single Blind Treatment Period |
| Treatment B | Active comparator | Drug: Abatacept, Drug: Adalimumab, Drug: MethotrexateAdalimumab Single Blind Treatment Period |
| Treatment C | Active comparator | Drug: AbataceptAbatacept Cumulative Treatment Period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptoms of RA for no more than 12 months prior to enrollment
- Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA
- Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses
- At least 3 tender \& 3 swollen joints
- Anti-cyclic citrullinated peptide (CCP) > 3X the upper limit of normal and positive rheumatoid factor
Key exclusion criteria (5 listed)
- History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc)
- Prior use of non-biologic therapy other than methotrexate
- Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy
- Subjects with chronic or recent acute serious infection
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia | Drug | Treatment A, Treatment B, Treatment C |
| AdalimumabAlso: Humira | Drug | Treatment B |
| Methotrexate | Drug | Treatment A, Treatment B |
Primary outcome
Percentage of Adverse Events (AEs)
Time frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an AE
Percentage of Participants With an Serious Adverse Events (SAEs)
Time frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an SAEs
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
Time frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (AEsDc)
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
Time frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (SAEsDc)
Percentage of Drug Related Adverse Events (DRAEs)
Time frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRAEs
Percentage of Drug Related Serious Adverse Events (DRSAEs)
Time frame: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRSAEs
Number of Deaths
Time frame: up to 85 days post last dose, approximately 40 weeks
Number of participants who experienced Death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34537057Rigby W, Buckner JH, Louis Bridges S Jr, Nys M, Gao S, Polinsky M, Ray N, Bykerk V. HLA-DRB1 risk alleles for RA are associated with differential clinical responsiveness to abatacept and adalimumab: data from a head-to-head, randomized, single-blind study in autoantibody-positive early RA. Arthritis Res Ther. 2021 Sep 18;23(1):245. doi: 10.1186/s13075-021-02607-7.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abatacept, Adalimumab and Methotrexate in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Adverse Events (AEs) (time frame: up to 85 days post last dose, approximately 40 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.