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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00929864
Date of registration: 29/06/2009
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: Abatacept Versus Adalimumab Head-to-Head
Scientific title: A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
Date of first enrolment: October 2009
Target sample size: 869
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00929864
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Argentina Canada Chile Peru United States
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

Inclusion Criteria:

- Moderate to severe Rheumatoid arthritis (RA) according to American College of
Rheumatology (ACR) criteria

- Methotrexate failure

- Naive to RA biologics

- =5 years duration of disease

- Disease Activity Score-28 C-reactive protein (DAS28 CRP) = 3.2

- Willingness to self-inject subcutaneous (SC) drug

Exclusion Criteria:

- Previous or current medical conditions that are warnings against the use of tumor
necrosis factor (TNF)-blocking agents

- History of active or chronic hepatitis

- Cancer in the last 5 years

- History of severe chronic or recurrent bacterial or viral infections

- Risk of tuberculosis

- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,
Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Adalimumab
Primary Outcome(s)
The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population [Time Frame: Day 1 to Day 365]
Secondary Outcome(s)
Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population [Time Frame: Day 1 to Day 729]
Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population [Time Frame: Day 1 to Day 365]
Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population [Time Frame: Day 1 to Day 729]
Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population [Time Frame: Day 1 to Day 729]
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population [Time Frame: Day 1 to 12 Months]
Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population [Time Frame: Baseline to Day 729]
Secondary ID(s)
IM101-235
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 03/01/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00929864
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