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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2008-001523-57-IT
Date of registration: 17/03/2009
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb International Corporation
Public title: Multicenter, 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 - ND
Scientific title: Multicenter, 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 - ND
Date of first enrolment: 23/12/2008
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001523-57
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: studio multicentrico, multinazionale in aperto If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Denmark France Germany Hungary Italy Norway Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1) Subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA (1987). 2) RA that has existed for longer than 6 months from the initial diagnosis of RA. 3) Subjects must have disease activity defined by a Disease Activity Score (DAS)28 CRP > 3.2, or a tender joint count of  6, a swollen joint count of  6, and a C reactive protein (CRP) measurement greater than the upper limit of normal (ULN). 4) Subjects must have been treated with methotrexate in a dose of at least 15 mg for at least 3 months before screening and on a stable dose for the last 28 days before the first dose of abatacept (Day 1). In subjects with intolerance to methotrexate, the dose may be reduced to a maximum tolerated dose (ie, 10 mg weekly) for at least 3 months before screening, and subjects must be on a stable dose for the last 28 days before the first dose of abatacept (Day 1). 5) Subjects must be naive to treatment with biologic disease-modifying anti-rheumatic drugs (DMARDs: anti-TNFα, anakinra, rituximab, or other investigational drug). 6) Subjects must have a total synovitis PDUS score >1 for at least 3 metacarpophalangeal joints at the screening visit and at the baseline visit (Day 1, before infusion).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Women who are unwilling or unable to use an acceptable method to avoid pregnancy, pregnant or breastfeeding. 2. Sexually active fertile men not using an acceptable method to avoid pregnancy if their partners are WOCBP. 3. Subjects who are impaired, incapacitated, or incapable of completing study related assessments. 4. Subjects who meet all diagnostic criteria for any other rheumatic disease 5. Subjects with active vasculitis , current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study. 6. Female subjects who have had a breast cancer screening that is suspicious for malignancy or history of cancer in the last 5 years. 7. Subjects who clinically, significantly abuse drugs or alcohol. 8. Subjects with evidence of active or latent bacterial or viral infections at the time of potential enrollment, including HIV, herpes zoster or cytomegalovirus 9. Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication. 10. Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection 11. Subjects at risk for tuberculosis (TB). 12. Subjects must not be positive for hepatitis B surface antigen 13. Subjects who are positive for hepatitis C antibody 14. Subjects with any of the following laboratory values: Hemoglobin < 8.5 g/dL, WBC < 3000/mm3, Platelets < 100,000/mm3, Serum creatinine > 2 times the ULN, Serum ALT or AST > 2 times the ULN 15. Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study. 16. Subjects who have at any time received treatment with any investigational drug within 28 days of the Day 1dose. 17. Subjects who have at any time received treatment with abatacept 18. Prisoners or subjects who are involuntarily incarcerated or who are compulsorily detained for treatment of either a psychiatric or physical illness.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
active rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid
Intervention(s)

Trade Name: ORENCIA
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: ABATACEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)
Main Objective: To assess the occurrence of early signs of response to abatacept with background methotrexate, as defined by improvement of synovitis measured by Power Doppler Ultrasonography of the affected metacarpophalangeal joints during the study in subjects with active rheumatoid arthritis and inadequate response to methotrexate
Primary end point(s): Efficacy and safety parameters will be assessed at each predefined timepoint: Days 1, 7, 15, 29, 43, 57, 85, 113, 141, 169, and 199. Primary efficacy assessments consist of Power Doppler Ultrasonography (PDUS) MCP joint assessments and the DAS28 CRP. The global PDUS score and DAS28 CRP will be calculated at all visits during 6 months of treatment. Safety will be assessed throughout the study via physical examinations; monitoring of vital signs, adverse events, and serious adverse events; pregnancy tests; and blood chemistry and hematology analyses.
Secondary Objective: To estimate the predictability of the total PDUS score or its components of the synovitis level of the MCP joints to disease activity measured by DAS28-CRP or DAS28-CRP-derived criteria at specified timepoints during the study.
Secondary Outcome(s)
Secondary ID(s)
2008-001523-57-NO
IM101-179
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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