| 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 ]
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- 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).
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| 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 ]
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- 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.
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| |
| 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
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| |
| |
| |
| 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 |