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Remission in Early Rheumatoid Arthritis
This study has been completed.
Study NCT00122382   Information provided by Bristol-Myers Squibb
First Received: July 19, 2005   Last Updated: September 14, 2009   History of Changes

July 19, 2005
September 14, 2009
July 2005
February 2009   (final data collection date for primary outcome measure)
  • The proportion of subjects who achieve remission as defined by a DAS 28 score less that 2.6. [ Time Frame: in 12 months of treatment (Day 365) ] [ Designated as safety issue: No ]
  • Joint damage progression measured by radiographic evaluation using the Genant‑Modified Sharp total score [ Time Frame: at 12 months of treatment (Day 365) ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve remission in 12 months of treatment (Day 365) as defined by a DAS 28 score less that 2.6.
  • Joint damage progression measured by radiographic evaluation using the Genant‑Modified Sharp total score at 12 months of treatment (Day 365).
Complete list of historical versions of study NCT00122382 on ClinicalTrials.gov Archive Site
  • Compare the proportion of subjects with an ACR50 response [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
  • Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
  • Compare the disease activity as measured by DAS 28 score [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
  • Compare the improvement in physical function using the HAQ disability index [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
  • Compare the improvement in health-related quality of life using SF-36 [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
  • Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
  • Assess the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, joint space narrowing and total score [ Time Frame: at month 24 (Day 729) ] [ Designated as safety issue: No ]
  • Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Assess the improvement in physical function [ Time Frame: at month 24 (Day 729) ] [ Designated as safety issue: No ]
  • Compare the proportion of subjects with an ACR50 response at month 12 (Day 365).
  • Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response at month 12 (Day 365).
  • Compare the disease activity as measured by DAS 28 score at month 12 (Day 365).
  • Compare the improvement in physical function using the HAQ disability index at month 12 (Day 365) and assess the improvement in physical function at month 24 (Day 729).
  • Compare the improvement in health-related quality of life using SF-36 at month 12 (Day 365).
  • Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing at month 12 (Day 365).
  • Assess the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, joint space narrowing and total score at month 24 (Day 729).
  • Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept.
 
Remission in Early Rheumatoid Arthritis
A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Rheumatoid Arthritis
  • Drug: abatacept and methotrexate
  • Drug: placebo and methotrexate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
750
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) <2 years; never received treatment with methotrexate; erosions noted on x-ray.
  • CRP >= 8.0 mg/L
  • Rheumatoid factor or anti CCP positive
  • Additional laboratory requirements

Exclusion Criteria:

  • Women and men who are not willing to use birth control
  • Diagnosed with other rheumatic disease
  • History of cancer within 5 years
  • Active tuberculosis
  • Treatment with another investigation drug within 28 days
  • Active bacterial or viral infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   United Kingdom
 
NCT00122382
Study Director, Bristol-Myers Squibb
IM101-023
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2009

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