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

NCT ID: NCT00048932

Last Updated: 2011-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1795 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.

Detailed Description

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This was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing designed study. The treatment period was 12 months. Eligible participants were randomized to 1 of 2 treatment groups: abatacept fixed dose approximating 10 mg/kg (based on participant's body weight; 500 mg for participants weighing \< 60kg; 750 mg for participants weighing 60 to 100 kg; and 1 gram for participants weighing \> 100 kg, monthly) or placebo intravenous (IV) infusion. All participants continued their background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period. Double-blind study medication (abatacept or placebo) was administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses.

All participants who completed the 12-month double-blind study period (Day 1 through Day 365), were eligible to continue into the open-label period. All eligible participants (active or placebo) were re-allocated to receive abatacept at a weight-tiered dose that approximated 10 mg/kg, based on their Day 365 body weight. Participants continued to receive infusions every 28 days.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Double-blind abatacept

Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period

Group Type ACTIVE_COMPARATOR

Double-blind Abatacept

Intervention Type DRUG

Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Day 1, 15, and 29.

Double-blind Placebo

Participants received Placebo (dextrose 5% water \[D5W\] for injection U.S.P or normal saline \[NS\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \[DMARDs\], or combination) throughout the double-blind treatment period.

Group Type PLACEBO_COMPARATOR

Double-blind Placebo

Intervention Type DRUG

Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.

Open-label Abatacept

Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.

Group Type ACTIVE_COMPARATOR

Open-label Abatacept

Intervention Type DRUG

Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Every 28 days.

Interventions

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Double-blind Abatacept

Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Day 1, 15, and 29.

Intervention Type DRUG

Double-blind Placebo

Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.

Intervention Type DRUG

Open-label Abatacept

Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Every 28 days.

Intervention Type DRUG

Other Intervention Names

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Orencia BMS-188667 Orencia BMS-188667

Eligibility Criteria

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Inclusion Criteria

* Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV
* Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day 1.

Exclusion:

* Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus \[SLE\], Scleroderma)
* Active tuberculosis (TB) requiring treatment within last 3 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Local Institution

Decatur, Alabama, United States

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Paradise, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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San Francisco, California, United States

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Loveland, Colorado, United States

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Hamden, Connecticut, United States

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Lake Worth, Florida, United States

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Largo, Florida, United States

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Blairsville, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Cumberland, Maryland, United States

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Westminster, Maryland, United States

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Boston, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Royal Oak, Michigan, United States

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Toms River, New Jersey, United States

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Los Alamos, New Mexico, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Hickory, North Carolina, United States

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Canton, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Elyria, Ohio, United States

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Youngstown, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Wyomissing, Pennsylvania, United States

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Columbia, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Ducktown, Tennessee, United States

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Nashville, Tennessee, United States

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Richmond, Virginia, United States

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Edmonds, Washington, United States

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Olympia, Washington, United States

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Tacoma, Washington, United States

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Menomonee Falls, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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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)

Other Identifiers

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IM101-031

Identifier Type: -

Identifier Source: org_study_id