Abatacept Versus Adalimumab Head-to-Head - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00929864

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab Abatacept

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 ]

Estimated Enrollment:	648
Study Start Date:	October 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Abatacept: Active Comparator	Drug: Abatacept Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Adalimumab: Active Comparator	Drug: Adalimumab Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)

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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 128 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-235
Study First Received:	June 29, 2009
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00929864 History of Changes
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:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Immunosuppressive Agents
Pharmacologic Actions
Abatacept
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010