Abatacept Versus Adalimumab Head-to-Head

• 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
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Chile, Peru, United States

Contacts

• Name: Bristol-Myers Squibb
• 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: Adalimumab

Drug: Abatacept

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 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]

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]

Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population [Time Frame: Day 1 to Day 729]

Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population [Time Frame: Day 1 to Day 729]

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]

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]

Secondary ID(s)

IM101-235

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/01/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00929864