A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00767325
• Date of registration: 06/10/2008
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography
• Scientific title: Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
• Date of first enrolment: December 2008
• Target sample size: 104
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00767325
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Denmark, France, Germany, Hungary, Italy, Norway, Spain, United Kingdom

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

Key inclusion riteria:

- Disease activity defined by a disease activity score 28-C-reactive protein >3.2, or
meeting the following criteria: a tender joint count =6; a swollen joint count =6;
C-reactive protein measurement greater than the upper limit of normal

- 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

Key exclusion criteria:

- Women of childbearing potential who are unwilling or unable to use birth control

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: Abatacept

Primary Outcome(s)

Mean Change From Baseline in Global Power Doppler Ultrasonography (PDUS) Score Assessing the Metacarpophalangeal (MCP) 2-5 Joints of Both Hands (LOCF Analysis) [Time Frame: Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169]

Earliest Time Point at Which Improvement of Core Component of the Global PDUS in the MCP (2-5) Joints of Both Hands Was Assessed [Time Frame: Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169]

Secondary Outcome(s)

Mean Change From Baseline in Global PDUS MCP 2-5 Component Scores Over Time (LOCF Analysis) [Time Frame: Days 7, 15, 29, and 169]

Number of Participants With Adverse Events (AEs) of Interest [Time Frame: Days 1 to 169 to 56 days following last infusion]

Number of Participants With Death as Outcome, Serious Adverse Events(SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs [Time Frame: Days 1 to 169 to 56 days following last infusion]

Number of Early (Days 7 to 113) Global PDUS MCP 2-5 Scores or Global PDUS Component MCP 2-5 Scores Associated With an Acceptable Predictability of Clinical Response at Day 169, As Assessed by DAS28-CRP [Time Frame: Days 1 to 169]

Secondary ID(s)

IM101-179

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/06/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00767325