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A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

NCT ID: NCT00409838

Last Updated: 2013-08-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of the study is to demonstrate the clinical efficacy of abatacept (body-weight tiered dose approximating 10 mg/kg) compared with placebo on a background of methotrexate after 6 months (Day 169) of treatment in Korean patients with active rheumatoid arthritis and an inadequate clinical response to methotrexate

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis, with inadequate response to methotrexate

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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Abatacept and Methotrexate

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

Methotrexate

Intervention Type DRUG

Tablets, Oral, ≥ 15 mg, weekly, 6 months

Placebo and Methotrexate

(standard of care)

Group Type PLACEBO_COMPARATOR

Methotrexate

Intervention Type DRUG

Tablets, Oral, ≥ 15 mg, weekly, 6 months

Placebo

Intervention Type DRUG

IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

Abatacept - Open Label

Open-label extension phase

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

Solution, intravenous, 10 mg/kg, every 28 days

Methotrexate

Intervention Type DRUG

Tablets, oral, 15 mg weekly to be adjusted according to patient condition

Interventions

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Abatacept

Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

Intervention Type DRUG

Methotrexate

Tablets, Oral, ≥ 15 mg, weekly, 6 months

Intervention Type DRUG

Placebo

IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months

Intervention Type DRUG

Abatacept

Solution, intravenous, 10 mg/kg, every 28 days

Intervention Type DRUG

Methotrexate

Tablets, oral, 15 mg weekly to be adjusted according to patient condition

Intervention Type DRUG

Other Intervention Names

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Orencia BMS-188667 Orencia BMS-188667

Eligibility Criteria

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Inclusion Criteria

* Rheumatoid arthritis (RA) for longer than 1 year from the time of the initial diagnosis of RA
* Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
* Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses

Exclusion Criteria

* Evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment
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

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Seoul, Sungdong-Gu, South Korea

Site Status

Local Institution

Anyang, , South Korea

Site Status

Local Institution

Daegu, , South Korea

Site Status

Local Institution

Daejeon, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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IM101-124

Identifier Type: -

Identifier Source: org_study_id