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A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00767325
First received: October 6, 2008
Last updated: December 8, 2011
Last verified: December 2011
History of Changes

October 6, 2008
December 8, 2011
December 2008
October 2011   (final data collection date for primary outcome measure)
Power Doppler Ultrasonography (PDUS) assessments of the MCP joints (2-5th) of both hands [ Time Frame: at screening and all visits until 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00767325 on ClinicalTrials.gov Archive Site
Global PDUS score, total PDUS score and components, and DAS28-CRP or DAS29-CRP derived criteria [ Time Frame: at specified timepoints during the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography
Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

The purpose of the study is to assess early signs of response to Abatacept+MTX my measuring improvement of your hand joints inflammation by using an ultrasound machine.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Rheumatoid Arthritis
Drug: Abatacept
Abatacept solution, IV, <60 kg will receive 500 mg, 60-100 kg will receive 750 mg, >100 kg will receive 100 mg on Day 1, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Other Names:
  • Orencia®
  • BMS-188667
Experimental: A
Intervention: Drug: Abatacept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Disease activity defined by a DAS28-CRP > 3.2, or all of the following criteria must be met; a tender joint count of ≥6, and a C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN)
  • Diagnosis of RA for more than 6 months
  • Total synovitis PDUS score >1 for at least 2 MCP joints (MCP2-5) and a total synovitis PDUS score ≥ 1 for at least one other MCP (MCP2-5)
  • Concomitant treatment with methotrexate for at least 3 months
  • No treatment with any background non biologic DMARD other than methotrexate for at least 28 days before treatment (Day 1)
  • Naive to treatment with biologic DMARDs

Exclusion Criteria:

  • Women of childbearing potential who are unwilling or unable to use birth control, specific medical history and concurrent diseases
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Hungary,   Italy,   Norway,   Spain,   United Kingdom
 
NCT00767325
IM101-179
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP