MedDataX Logo

Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

NCT ID: NCT00124982

Last Updated: 2012-02-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

NCT00048568

Rheumatoid Arthritis
COMPLETED PHASE3

A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

NCT00048932

Rheumatoid Arthritis
COMPLETED PHASE3

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

NCT00484289

Rheumatoid Arthritis
COMPLETED PHASE3

An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

NCT00162201

Rheumatoid Arthritis
COMPLETED PHASE1

A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

NCT04909801

Rheumatoid Arthritis
ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open-label Abatacept (ABA)-Previous User

In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Intervention Type DRUG

During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

Open-label ABA-Current User

In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Intervention Type DRUG

During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

Anti-Tumor Necrosing Factor (TNF) Therapy

Intervention Type DRUG

Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months

Long-term ABA

Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Intervention Type DRUG

During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abatacept

IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Intervention Type DRUG

Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1).

Intervention Type DRUG

Anti-Tumor Necrosing Factor (TNF) Therapy

Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Orencia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Completed double-blind portion of the IM101064 study.
* Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
* American College of Rheumatology (ACR) functional class I, II, III
* Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria

* Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
* History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Birmingham, Alabama, United States

Site Status

Local Institution

Huntsville, Alabama, United States

Site Status

Local Institution

Paradise Valley, Arizona, United States

Site Status

Local Institution

Peoria, Arizona, United States

Site Status

Local Institution

Tucson, Arizona, United States

Site Status

Local Institution

Long Beach, California, United States

Site Status

Local Institution

Palm Springs, California, United States

Site Status

Local Institution

Palo Alto, California, United States

Site Status

Local Institution

San Diego, California, United States

Site Status

Local Institution

Santa Monica, California, United States

Site Status

Local Institution

Colorado Springs, Colorado, United States

Site Status

Local Institution

Denver, Colorado, United States

Site Status

Local Institution

Danbury, Connecticut, United States

Site Status

Local Institution

Hamden, Connecticut, United States

Site Status

Local Institution

Trumbull, Connecticut, United States

Site Status

Local Institution

Washington D.C., District of Columbia, United States

Site Status

Local Institution

Aventura, Florida, United States

Site Status

Local Institution

Clearwater, Florida, United States

Site Status

Local Institution

Fort Lauderdale, Florida, United States

Site Status

Local Institution

Jupiter, Florida, United States

Site Status

Local Institution

Largo, Florida, United States

Site Status

Local Institution

Sarasota, Florida, United States

Site Status

Local Institution

Atlanta, Georgia, United States

Site Status

Local Institution

Blue Ridge, Georgia, United States

Site Status

Local Institution

Macon, Georgia, United States

Site Status

Local Institution

Morton Grove, Illinois, United States

Site Status

Local Institution

Evansville, Indiana, United States

Site Status

Local Institution

Indianapolis, Indiana, United States

Site Status

Local Institution

Des Moines, Iowa, United States

Site Status

Local Institution

Kansas City, Kansas, United States

Site Status

Local Institution

Prairie Village, Kansas, United States

Site Status

Local Institution

Bowling Green, Kentucky, United States

Site Status

Local Institution

Louisville, Kentucky, United States

Site Status

Local Institution

New Orleans, Louisiana, United States

Site Status

Local Institution

Boston, Massachusetts, United States

Site Status

Local Institution

Peabody, Massachusetts, United States

Site Status

Local Institution

Springfield, Massachusetts, United States

Site Status

Local Institution

Worcester, Massachusetts, United States

Site Status

Local Institution

Ann Arbor, Michigan, United States

Site Status

Local Institution

East Lansing, Michigan, United States

Site Status

Local Institution

Grand Rapids, Michigan, United States

Site Status

Local Institution

Lansing, Michigan, United States

Site Status

Local Institution

Petockey, Michigan, United States

Site Status

Local Institution

Minneapolis, Minnesota, United States

Site Status

Local Institution

Saint Paul, Minnesota, United States

Site Status

Local Institution

Omaha, Nebraska, United States

Site Status

Local Institution

Las Vegas, Nevada, United States

Site Status

Local Institution

Lebanon, New Hampshire, United States

Site Status

Local Institution

Nashua, New Hampshire, United States

Site Status

Local Institution

Cherry Hill, New Jersey, United States

Site Status

Local Institution

Dover, New Jersey, United States

Site Status

Local Institution

Manalapan, New Jersey, United States

Site Status

Local Institution

New Brunswick, New Jersey, United States

Site Status

Local Institution

Somerset, New Jersey, United States

Site Status

Local Institution

Teaneck, New Jersey, United States

Site Status

Local Institution

Voorhees Township, New Jersey, United States

Site Status

Local Institution

Albany, New York, United States

Site Status

Local Institution

Brooklyn, New York, United States

Site Status

Local Institution

Hewlett, New York, United States

Site Status

Local Institution

Lake Success, New York, United States

Site Status

Local Institution

Mineola, New York, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

Olean, New York, United States

Site Status

Local Institution

Orchard Park, New York, United States

Site Status

Local Institution

Rochester, New York, United States

Site Status

Local Institution

Schenectady, New York, United States

Site Status

Local Institution

Smithtown, New York, United States

Site Status

Local Institution

Syracuse, New York, United States

Site Status

Local Institution

Asheville, North Carolina, United States

Site Status

Local Institution

Charlotte, North Carolina, United States

Site Status

Local Institution

Hickory, North Carolina, United States

Site Status

Local Institution

Wilmington, North Carolina, United States

Site Status

Local Institution

Bismarck, North Dakota, United States

Site Status

Local Institution

Akron, Ohio, United States

Site Status

Local Institution

Beachwood, Ohio, United States

Site Status

Local Institution

Cleveland, Ohio, United States

Site Status

Local Institution

Columbus, Ohio, United States

Site Status

Local Institution

Mayfield Village, Ohio, United States

Site Status

Local Institution

Youngstown, Ohio, United States

Site Status

Local Institution

Portland, Oregon, United States

Site Status

Local Institution

Bala-Cynwyd, Pennsylvania, United States

Site Status

Local Institution

Bethlehem, Pennsylvania, United States

Site Status

Local Institution

Camp Hill, Pennsylvania, United States

Site Status

Local Institution

Duncansville, Pennsylvania, United States

Site Status

Local Institution

Erie, Pennsylvania, United States

Site Status

Local Institution

Meadville, Pennsylvania, United States

Site Status

Local Institution

Philadelphia, Pennsylvania, United States

Site Status

Local Institution

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution

West Reading, Pennsylvania, United States

Site Status

Local Institution

Wexford, Pennsylvania, United States

Site Status

Local Institution

Willow Grove, Pennsylvania, United States

Site Status

Local Institution

Providence, Rhode Island, United States

Site Status

Local Institution

Myrtle Beach, South Carolina, United States

Site Status

Local Institution

Simpsonville, South Carolina, United States

Site Status

Local Institution

Sioux Falls, South Dakota, United States

Site Status

Local Institution

Hixson, Tennessee, United States

Site Status

Local Institution

Knoxville, Tennessee, United States

Site Status

Local Institution

Austin, Texas, United States

Site Status

Local Institution

Corpus Christi, Texas, United States

Site Status

Local Institution

Dallas, Texas, United States

Site Status

Local Institution

Galveston, Texas, United States

Site Status

Local Institution

Houston, Texas, United States

Site Status

Local Institution

Lubbock, Texas, United States

Site Status

Local Institution

San Antonio, Texas, United States

Site Status

Local Institution

Sugarland, Texas, United States

Site Status

Local Institution

Burke, Virginia, United States

Site Status

Local Institution

Chesapeake, Virginia, United States

Site Status

Local Institution

Fairfax, Virginia, United States

Site Status

Local Institution

Salem, Virginia, United States

Site Status

Local Institution

Seattle, Washington, United States

Site Status

Local Institution

Vancouver, Washington, United States

Site Status

Local Institution

Glendale, Wisconsin, United States

Site Status

Local Institution

La Crosse, Wisconsin, United States

Site Status

Local Institution

Madison, Wisconsin, United States

Site Status

Local Institution

Brussels, , Belgium

Site Status

Local Institution

Leuven, , Belgium

Site Status

Local Institution

Prague, , Czechia

Site Status

Local Institution

Boisguillaume, , France

Site Status

Local Institution

Bordeaux, , France

Site Status

Local Institution

Brest, , France

Site Status

Local Institution

Chambray-lès-Tours, , France

Site Status

Local Institution

Montpellier, , France

Site Status

Local Institution

Nice, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Rennes, , France

Site Status

Local Institution

Strasbourg, , France

Site Status

Local Institution

Toulouse, , France

Site Status

Local Institution

Freiburg im Breisgau, , Germany

Site Status

Local Institution

Hamburg, , Germany

Site Status

Local Institution

Kiel, , Germany

Site Status

Local Institution

Leipzig, , Germany

Site Status

Local Institution

Tübingen, , Germany

Site Status

Local Institution

Cork, Cork, Ireland

Site Status

Local Institution

Genova, , Italy

Site Status

Local Institution

Milan, , Italy

Site Status

Local Institution

Torino, , Italy

Site Status

Local Institution

Guadalajara, Jalisco, Mexico

Site Status

Local Institution

Distrito Federal, Mexico City, Mexico

Site Status

Local Institution

Alicante, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Guipuzcoa, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Santander, , Spain

Site Status

Local Institution

Valencia, , Spain

Site Status

Local Institution

Cambridge, Cambridgeshire, United Kingdom

Site Status

Local Institution

Manchester, Greater Manchester, United Kingdom

Site Status

Local Institution

Maidstone, Kent, United Kingdom

Site Status

Local Institution

Leeds, North Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Czechia France Germany Ireland Italy Mexico Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Schiff M, Pritchard C, Huffstutter JE, Rodriguez-Valverde V, Durez P, Zhou X, Li T, Bahrt K, Kelly S, Le Bars M, Genovese MC. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. doi: 10.1136/ard.2008.099218. Epub 2008 Dec 15.

Reference Type BACKGROUND
PMID: 19074911 (View on PubMed)

Alten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.

Reference Type DERIVED
PMID: 29329602 (View on PubMed)

Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

Reference Type DERIVED
PMID: 27889300 (View on PubMed)

Hassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. doi: 10.1185/030079908x297376. Epub 2008 Apr 9.

Reference Type DERIVED
PMID: 18402714 (View on PubMed)

Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis. 2008 Apr;67(4):547-54. doi: 10.1136/ard.2007.074773. Epub 2007 Oct 5.

Reference Type DERIVED
PMID: 17921185 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IM101-064

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase IIIB Subcutaneous Abatacept Monotherapy Study
NCT00547521 COMPLETED PHASE3
Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.
NCT00048581 COMPLETED PHASE3
Remission and Joint Damage Progression in Early Rheumatoid Arthritis
NCT00122382 COMPLETED PHASE3
A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis
NCT03882008 COMPLETED PHASE4
Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)
NCT01088321 COMPLETED
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)
NCT00254293 COMPLETED PHASE1/PHASE2
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
NCT02504268 COMPLETED PHASE3
Abatacept With Methotrexate- Phase IIB
NCT00162266 COMPLETED PHASE2
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
NCT00124449 COMPLETED PHASE2
Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis
NCT02885818 COMPLETED
Abatacept Versus Adalimumab Head-to-Head
NCT00929864 COMPLETED PHASE3
Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients
NCT01001832 COMPLETED PHASE2/PHASE3
A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
NCT00420199 COMPLETED PHASE3
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
NCT02557100 COMPLETED PHASE4
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
NCT03086343 COMPLETED PHASE3
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
NCT00095147 COMPLETED PHASE3
Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients
NCT01351480 COMPLETED PHASE3
Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis
NCT01142726 COMPLETED PHASE3
Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)
NCT01088360 ACTIVE_NOT_RECRUITING
A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
NCT00345748 COMPLETED PHASE2
A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone
NCT02066389 COMPLETED PHASE2
Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis
NCT00649545 APPROVED_FOR_MARKETING
Post-marketing Study Assessing the Long-Term Safety of Abatacept
NCT02169544 COMPLETED
Methotrexate-Inadequate Response Study
NCT00559585 COMPLETED PHASE3
Safety Study of Abatacept to Treat Rheumatoid Arthritis
NCT01247766 COMPLETED