NCT00989235

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Apr 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 3, 2011

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

October 2, 2009

Results QC Date

May 12, 2011

Last Update Submit

June 18, 2011

Conditions

Rheumatoid Arthritis

Keywords

NOS

Outcome Measures

Primary Outcomes (1)

  • Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)

    An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score \>=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).

    Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Secondary Outcomes (19)

  • Number of Participants Experiencing Disease Relapse

    After 12 Months of treatment

  • Mean Time-Matched Baseline DAS28 CRP Scores

    Baseline

  • Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment

    Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365

  • Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)

    After 12 months of treatment

  • Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment

    After 12 months of treatment

  • +14 more secondary outcomes

Study Arms (2)

Abatacept (10 mg/Kg)

ACTIVE COMPARATOR
Drug: Abatacept

Abatacept (5 mg/Kg)

ACTIVE COMPARATOR
Drug: Abatacept

Interventions

AbataceptDRUG

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

Also known as: BMS-188667
Abatacept (10 mg/Kg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25550337DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Results Point of Contact

Title
BMS Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

April 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 21, 2011

Results First Posted

June 3, 2011

Record last verified: 2011-06