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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-FR
Date of registration: 21/10/2008
Prospective Registration: Yes
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
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
Date of first enrolment: 04/11/2008
Target sample size: 100
Recruitment status: Authorised-recruitment may be ongoing or finished
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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
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 must meet the 1987 criteria of the American Rheumatism Association
for the classification of RA
2) Subjects must have had a diagnosis of RA for more than 6 months from the time
of the initial diagnosis of RA.
3) Subjects must have disease activity defined by a DAS28-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 a total synovitis PDUS score >1 for at least 3 MCPs at the
screening visit and at the baseline (Day 1, before infusion) visit.
5) Subjects must have been treated with methotrexate 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
could be reduced to a maximum tolerated dose (ie, 10 mg weekly) 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).
6) Subjects who received combination therapy (methotrexate plus another
nonbiologic DMARD) before study entry require washout. These subjects must
not be treated with any background nonbiologic DMARD other than methotrexate
for at least 28 days before treatment (Day 1). In the case of leflunomide, the
washout period is 8 weeks unless subjects take cholestyramine according to the
manufacturer’s recommendation.
7) Subjects who have received oral corticosteroids during the 28 days before
treatment (Day 1) must have been on a stable dose for at least 25 out of 28 days
and on a total dose of = the equivalent of 10 mg prednisone/day.
8) Subjects must be naive to treatment with biologic DMARDs (infliximab,
anakinra, etanercept, adalimumab, rituximab, and any investigational biologic
DMARD).
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)Subjects who are impaired, incapacitated, or incapable of completing studyrelated
assessments.
2) Subjects who meet all diagnostic criteria for any other rheumatic disease (eg,
lupus erythematous).
3) Subjects who underwent previous MCP arthroplasty, have such a procedure
scheduled, or anticipate the need for such a procedure during the study.
4) Subjects with active vasculitis of a major organ system, with the exception of
rheumatoid nodules.
5) Subjects with 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 and in whom the possibility of malignancy cannot be reasonably
excluded by additional clinical, laboratory, or other diagnostic evaluations
7) Subjects with a history of cancer in the last 5 years, other than non-melanoma
skin cell cancers cured by local resection or carcinoma in situ. Existing nonmelanoma
skin cell cancers should be removed, the lesion site healed and residual
cancer ruled out before administration of the study drug.
8) Subjects who clinically, significantly abuse drugs or alcohol.
9) Subjects with evidence (as assessed by the investigator) of active or latent
bacterial or viral infections at the time of potential enrollment, including subjects
with evidence of human immunodeficiency virus (HIV).
10) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than
2 months before the informed consent document was signed.
11) Subjects who have received any live vaccines within 3 months of the anticipated
first dose of study medication.
12) Subjects with any serious bacterial infection within the last 3 months, unless
treated and resolved with antibiotics, or any chronic bacterial infection (eg,
chronic pyelonephritis, osteomyelitis or bronchiectasis).
13) Subjects at risk for tuberculosis (TB). Specifically excluded from this study will
be subjects with:
• A history of active TB within the last 3 years, even if it was treated.
• A history of active TB greater than 3 years ago, unless there is
documentation that the prior anti-TB treatment was appropriate in duration
and type.
• Current clinical, radiographic, or laboratory evidence of active TB.
• Latent TB that was not successfully treated (= 4 weeks).
14) Subjects must not be positive for hepatitis B surface antigen.
15) Subjects who are positive for hepatitis C antibody if the presence of hepatitis C
virus was also shown with polymerase chain reaction or recombinant immunoblot
assay.
16) Subjects with any of the following laboratory values
• Hemoglobin < 8.5 g/dL
• WBC < 3000/mm3 (< 3 x 109/L)
• Platelets < 100,000/mm3 (< 3 x 109/L)
• Serum creatinine > 2 times the ULN
• Serum ALT or AST > 2 times the ULN
17) Any other laboratory test results that, in the opinion of the investigator, might
place a subject at unacceptable risk for participation in the study.
18) Subjects who have at any time received treatment with any investigational drug
within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1
dose.
19) Subjects who have at any time received treatment with abatacept (BMS-188667
or CTLA4Ig).
20)Women who are pregnant or breastfeeding.
21) Women with a positive pregnancy test on en


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Intervention(s)

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Other descriptive name: CTLA4Ig
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)
Main Objective: The main objective is 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): Study Assessments and Primary Endpoints:
• 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: The second objective is 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
IM101179
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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