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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: 1 May 2012
Main ID:  EUCTR2004-002620-18-BE
Date of registration: 04/08/2005
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb International Corporation
Public title: A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory Arthritis at High Risk for the Development of Rheumatoid Arthritis
Scientific title: A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory Arthritis at High Risk for the Development of Rheumatoid Arthritis
Date of first enrolment: 30/06/2005
Target sample size: 250
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002620-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Belgium Germany Italy Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1)Subjects must have a diagnosis of UA. A subject with UA should have symptomatic
clinical synovitis of two or more joints and should possess at least one and not more
than three of the criteria for classification of RA of the American Rheumatism
Association (1987). See Appendices 1 and 2of the protocol.
2)Subjects must not meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous).
3)The subject’s disease duration [defined as the time from the onset of symptoms (joint pain, swelling, or stiffness) of arthritis to enrollment ] must be less than one year.
4) Subjects must have be positive for autoantibodies against cyclic citrullinated peptides by ELISA (Immunoscan RA Mark 2, Euro-Diagnostica, Arnhem, The Netherlands).
5)Men and women, ages 18 - 75 years old. Men and WOCBP are eligible if they are practicing effective contraceptive measures.
-WOCBP and men must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last infusion of abatacept in such a manner that the risk of pregnancy is minimized.

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)WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 10 weeks after the last infusion of abatacept.
2)Women who are pregnant or breastfeeding or with a positive pregnancy test on enrollment or prior to study drug administration.
3)Males unwilling or unable to use an adequate method of contraception for the entire study period and for up to 10 weeks after the last infusion of study medication.
4) Subjects who are impaired, incapacitated, or incapable of completing study related
assessments.
5) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
erythematous).
6) Undifferentiated Arthritis duration of greater than one year
7) Subjects who have previously received treatment with an approved biologic RA
therapy (infliximab, etanercept, anakinra, adalimumab).
8) Subjects with active vasculitis of a major organ system.
9) Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease.
Concomitant medical conditions that, in the opinion of the investigator, might place
the subject at unacceptable risk for participation in this study.
10) Female subjects, who have not had age and/or risk factor appropriate breast cancer screening (as defined by published guidelines and/or local standards endorsed by the national cancer or medical society and/or the Ministry of Health), or who have had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations (Please refer to Section 7.3.2).
11) Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing.
12) Subjects who have clinically significant drug or alcohol abuse.
13) Subjects with any serious acute bacterial infection (such as pneumonia or
pyelonephritis unless treated and completely resolved with antibiotics).
14) Subjects with severe chronic or recurrent bacterial infections (such as recurrent
pneumonia, chronic bronchiectasis).
15) Subjects with active tuberculosis (TB) requiring treatment within the previous
3 years. Subjects with a positive PPD at screening will not be eligible for the study
unless active TB infection has been ruled out, and they have a negative chest x-ray at enrollment. A PPD response that is equal to or greater than 10 mm should be
considered a positive test, although a lower threshold (5 mm) may be applied as
determined by the clinical circumstance and investigator according to published
guidelines and/or local standards endorsed by the medical society. (Section 7.3.2)
16) Subjects with herpes zoster that resolved less than 2 months prior to enrollment.
17) 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) infection.
18) Subjects who have at any time received treatment with CTLA4Ig, or abatacept.
19) Subjects who have received treatment with any investigational drug within 28 days(or less than 5 terminal half-lives of elimination) of the Day 1 dose.
20)Subjects currently receiving treatment with immunoadsorption columns (such


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis, NOS
Intervention(s)

Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for injection
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-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: To assess the proportion of subjects with UA who develop RA as defined by 1987 ARA criteria one year after the start of blinded study medication.
Primary end point(s): The primary outcome of the study will be the proportion of subjects with a
diagnosis of RA by 1987 ARA criteria at 12 months. Secondary efficacy outcome measures include the proportion of subjects with a diagnosis of RA by 1987 ARA criteria at 24 months, the proportion of subjects with persistent symptomatic clinical synovitis at 6, 12, and 24 months, the mean full DAS (CRP) score at 6, 12, and 24 months, the proportion of subjects with a DAS score of <1.6 at 6, 12, and 24 months,
titers of RA-related autoantibodies, and inflammation and structural damage (degree of synovitis, erosions and joint space narrowing) on MRI using a centralized reader blinded to sequence and treatment. Subject reported outcomes will include the HAQ and SF-36. The changes in core components of the ACR RA composite variable will be assessed over time between the two treatment groups as a tertiary objective.
Secondary Objective: To assess the following criteria:
1) The proportion of subjects with UA who develop RA as defined by 1987
ARA criteria two years after the start of blinded study medication.
2)The degree of synovitis and structural joint damage of the hands (carpal,MCP & PIP joints) at 6, 12 & 24 months after the start of medication between the
2 treatment groups using dynamic MRI imaging.
3)The proportion of subjects with persistent symptomatic clinical synovitis at 6, 12 & 24 months after the start of medication between the 2 treatment groups & also subjects with a full DAS score of <1.6 at 6,12 &24 months.
4) The pharmacodynamic effect of abatacept on serum levels of autoantibodies
[IgM rheumatoid factor & anti-cyclic citrullinated peptide (anti-CCP2)].
5)Disease activity over time between the treatment groups using the mean
values of the full DAS(CRP) score.
See protocol for additonal secondary objectives.
Secondary Outcome(s)
Secondary ID(s)
2004-002620-18-DE
IM101-046
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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