Text Size

Abatacept Versus Adalimumab Head-to-Head

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00929864
First received: June 29, 2009
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Abatacept
Drug: Adalimumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The proportion of subjects meeting the ACR criteria of 20% improvement (ACR 20) after 12 months of treatment [ Time Frame: Day 365 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The comparative safety profile of 12 and 24 months treatment of abatacept vs. adalimumab estimated by the rate of SAEs, serious infections, and pre-specified opportunistic infections [ Time Frame: Day 1, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
  • Radiographic effect of 12 and 24 months Tx of abatacept vs adalimumab estimated by non-progressors rate from baseline using smallest detectable difference in joint damage measured by radiographic evaluation using modified vanderHeijde total Sharp score [ Time Frame: Day 1, Day 365, Day 729 ] [ Designated as safety issue: No ]
  • The comparative retention profile of 12 months (Day 365) and 24 months (Day 729) treatment of abatacept vs. adalimumab estimated by the rate of discontinuation for any cause [ Time Frame: Day 1, Day 365, Day 729 ] [ Designated as safety issue: Yes ]
  • The comparative tolerability of 12 months (Day 365) and 24 months (Day 729) treatment of abatacept vs. adalimumab estimated by the rate of injection site reactions and induction of autoantibodies. [ Time Frame: Day 1, Day 365, Day 729 ] [ Designated as safety issue: Yes ]

Enrollment: 662
Study Start Date: October 2009
Study Completion Date: November 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abatacept Drug: Abatacept
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Other Names:
  • Orencia
  • BMS-188667
Active Comparator: Adalimumab Drug: Adalimumab
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Other Name: Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe RA according to ACR criteria
  • MTX failure
  • Naive to RA biologics
  • ≤5 years duration of disease
  • DAS28 CRP ≥ 3.2
  • Willingness to self-inject SC drug

Exclusion Criteria:

  • Previous or current medical conditions that are warnings against the use of 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, GI, pulmonary, cardiac, neurologic, or cerebral disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929864

  Show 84 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00929864     History of Changes
Other Study ID Numbers: IM101-235
Study First Received: June 29, 2009
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Minesterio de Salud
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
 Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013