Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis

NCT ID: NCT00989235

Last Updated: 2011-06-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this exploratory sub-study was to evaluate from a clinical perspective the impact on disease activity of lowering the dose of abatacept from 10 mg/kg to 5 mg/kg in subjects who had achieved remission (Disease Activity Score 28 \[DAS 28\]-erythrocyte sedimentation rate \[ESR\] \< 2.6) at Day 701 of study IM101023.

Detailed Description

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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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Abatacept (10 mg/Kg)

Group Type ACTIVE_COMPARATOR

Abatacept

Intervention Type DRUG

IV solution, IV, 10 mg/Kg, Once monthly, 1 year

Abatacept (5 mg/Kg)

Group Type ACTIVE_COMPARATOR

Abatacept

Intervention Type DRUG

IV solution, IV, 5 mg/Kg, Once monthly, 1 year

Interventions

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Abatacept

IV solution, IV, 10 mg/Kg, Once monthly, 1 year

Intervention Type DRUG

Abatacept

IV solution, IV, 5 mg/Kg, Once monthly, 1 year

Intervention Type DRUG

Other Intervention Names

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BMS-188667 BMS-188667

Eligibility Criteria

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Inclusion Criteria

* Subjects who have completed the main study, are willing to participate and have a DAS 28 ESR score of \< 2.6 on Day 701 of the main study

Exclusion Criteria

* None
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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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

References

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Westhovens R, Robles M, Ximenes AC, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Murthy B. Maintenance of remission following 2 years of standard treatment then dose reduction with abatacept in patients with early rheumatoid arthritis and poor prognosis. Ann Rheum Dis. 2015 Mar;74(3):564-8. doi: 10.1136/annrheumdis-2014-206149. Epub 2014 Dec 30.

Reference Type DERIVED
PMID: 25550337 (View on PubMed)

Other Identifiers

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Eudrac # 2002-000784-26

Identifier Type: -

Identifier Source: secondary_id

IM101-023 LT (Sub study)

Identifier Type: -

Identifier Source: org_study_id

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