A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography
NCT ID: NCT00767325
Last Updated: 2013-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
104 participants
INTERVENTIONAL
2008-12-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Abatacept, 10 mg/kg
Abatacept
Abatacept, 10 mg/kg, solution given intravenously on Days 1, 15, 29,57, 85, 113, 141, and 169
Methotrexate
Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline
Interventions
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Abatacept
Abatacept, 10 mg/kg, solution given intravenously on Days 1, 15, 29,57, 85, 113, 141, and 169
Methotrexate
Methotrexate administered in a dose of 15 mg/week or higher for at least 3 months and at a stable dose for at least 28 days prior to baseline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of rheumatoid arthritis for longer than 6 months from time of initial diagnosis
* Total synovitis power Doppler ultrasonography (PDUS) score \>1 for at least 2 metacarpophalangeal (MCP) joints (MCP2-5) and a total synovitis PDUS score ≥1 for at least 1 other MCP joint (MCP2-5)
* Concomitant treatment with methotrexate at a dose ≥15 mg for at least 3 months before Day 1 and a stable dose for the last 28 days before Day 1
* No treatment with any background nonbiologic disease-modifying antirheumatic drug (DMARD) other than methotrexate for at least 28 days before treatment (Day 1)
* Stable dose of corticosteroids equivalent of 10 mg prednisone /day during the 28 days prior to Day 1
* Naive to treatment with biologic DMARDs
Exclusion Criteria
* Women who are pregnant or breastfeeding
* Meeting all diagnostic criteria for any other rheumatic disease
* Previous MCP arthroplasty, with such a procedure scheduled, or anticipating the need for such a procedure during the study. Participants who had undergone or were scheduled to undergo joint arthroplasties other than of the MCP joints were permitted to enroll in the study provided all other eligibility criteria were met.
* Active vasculitis of a major organ system with the exception of rheumatoid nodule
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to rheumatoid arthritis
* History of cancer in the last 5 years, other than nonmelanoma skin cell cancer cured by local resection or carcinoma in situ. Existing nonmelanoma skin cell cancers should have been removed, the lesion site healed, and residual cancer ruled out prior to administration of study medication
* Clinically significant abuse of alcohol or drugs
* Evidence of active or latent bacterial or viral infections at the time of potential enrollment
* Herpes zoster or cytomegalovirus infection that resolved less than 2 months before the informed consent document was signed
* For participants at risk for tuberculosis (TB):
* A history of active (TB) within the last 3 years, even if treated
* Latent TB that was not successfully treated ≥4 weeks
* Current clinical, radiographic, or laboratory evidence of active TB.
* Participants who have received live vaccines within 3 months of the anticipated first dose of study medication
* Participants with positive test results for hepatitis B surface antigen or hepatitis C antibody, with hepatitis C virus detected with polymerase chain reaction or recombinant immunoblot assay.
* Participants with hemoglobin level \<8.5 g/dL or white blood cell count\< 3000/mm\^3 or platelet count \<100,000/mm\^3 or serum creatinin level \>2\*the upper limit of normal (ULN) or serum alanine transaminase level or aspartate aminotransferase level \>2\*ULN
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Glostrup Municipality, , Denmark
Local Institution
Bois-Guillaume, , France
Local Institution
Boulogne, , France
Local Institution
Échirolles, , France
Local Institution
Nice, , France
Local Institution
München, , Germany
Local Institution
Budapest, , Hungary
Local Institution
Jesi (Ancona), , Italy
Local Institution
Pisa, , Italy
Local Institution
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution
Siena, , Italy
Local Institution
Verona, , Italy
Local Institution
Oslo, , Norway
Local Institution
Trondheim, , Norway
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Leeds, North Yorkshire, United Kingdom
Countries
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References
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D'Agostino MA, Boers M, Wakefield RJ, Berner Hammer H, Vittecoq O, Filippou G, Balint P, Moller I, Iagnocco A, Naredo E, Ostergaard M, Gaillez C, Le Bars M. Exploring a new ultrasound score as a clinical predictive tool in patients with rheumatoid arthritis starting abatacept: results from the APPRAISE study. RMD Open. 2016 May 5;2(1):e000237. doi: 10.1136/rmdopen-2015-000237. eCollection 2016.
Golinski ML, Vandhuick T, Derambure C, Freret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loet X, Vittecoq O, Lequerre T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFalpha inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.
D'Agostino MA, Wakefield RJ, Berner-Hammer H, Vittecoq O, Filippou G, Balint P, Moller I, Iagnocco A, Naredo E, Ostergaard M, Boers M, Gaillez C, Van Holder K, Le Bars M; OMERACT-EULAR-Ultrasound Task Force. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis. 2016 Oct;75(10):1763-9. doi: 10.1136/annrheumdis-2015-207709. Epub 2015 Nov 20.
Related Links
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Investigator Inquiry form
Other Identifiers
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IM101-179
Identifier Type: -
Identifier Source: org_study_id
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