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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: 10 June 2014
Main ID:  EUCTR2010-018674-20-IT
Date of registration: 17/12/2010
Prospective Registration: Yes
Primary sponsor: Bristol Myers Squibb International Corporation
Public title: A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - ND
Scientific title: A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - ND
Date of first enrolment: 21/10/2010
Target sample size: 470
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018674-20
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: yes Placebo: yes Other: no  
Phase: 
Countries of recruitment
Denmark Finland France Germany Italy Sweden
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1/ Signed Written Informed Consent a) Subject is willing to participate in the study and signed the informed consent 2/ Target Population a) Subjects have active clinical synovitis of at least 2 joints, 1 of which must be a small joint, for at least 8 weeks at the Screening Visit. Distal interphalangeal joints (DIP)s do not count toward this requirement b) Subjects have had the onset of persistent symptoms for = 2 years prior to the Screening Visit. c) Subjects have a DAS28-CRP = 3.2 at the Screening Visit d) Subjects are positive for anti-CCP2. e) Subjects are MTX naive or have minimum exposure to MTX defined as no more than 10 mg/wk for no more than 4 weeks and no dose for 1 month prior to the Screening Visit. f) Subjects are biologic naive and have not received treatment with an approved or investigational biologic RA therapy (for ex, infliximab, etanercept, anakinra, adalimumab, rituximab, tocilizumab, golimumab, and certolizumab) prior to screening. g) Subjects receiving oral corticosteroid treatment must be at the equivalent of = 10 mg predinisone daily for = 3 months prior to randomization. 3/ Age and Reproductive Status a) Men and women, ages = 18 b) Men and women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study for up to 10 weeks (14 weeks for EU) after the last dose of abatacept in such a manner that the risk of pregnancy is minimized. See Protocol Section 3.3.4 for the definition of WOCBP. c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational product. d) Women must not be breastfeeding e) Investigators should follow the manufacturer’s recommendations for MTX. f) Subjects must be able to receive an MRI. See Protocol Section 3.3.4 for contraindications
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.Target Disease Exceptions a)Subjects who meet diagnostic criteria for other rheumatic disease(eg.lupus erythematosus).2.Medical History and Concurrent Diseases a)Subjects who are impaired,incapacitated,or incapable of completing study related assessments. b)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. c) Female subjects who 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 d)Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Subjects with carcinoma in situ, treated with definitive surgical intervention prior to study entry, are allowed. e)Subjects who have clinically significant drug or alcohol abuse.f) Subjects with any serious acute bacterial infection(such as pneumonia or pyelonephritis unless treated and completely resolved with antibiotics). g)Subjects with severe chronic or recurrent bacterial infections(such as recurrent pneumonia, chronic bronchiectasis). h)Subjects at risk for tuberculosis (TB).Specifically, subjects with: i)Current clinical, radiographic or laboratory evidence of active TB. ii)A history of active TB within the last 3 years even if it was treated. iii)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. iv)Latent TB which was not successfully treated. Subjects with a positive TB screening test indicative of latent TB will not be eligible for the study unless active TB infection has been ruled out and they have initiated treatment for latent TB with isoniazid (INH) for at least 4 weeks prior to dosing of study drug and they have a negative chest x-ray at enrollment.Such subjects should complete 9 months of INH treatment. i) Subjects with herpes zoster that resolved less than 2 months prior to enrollment. j)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 3.Physical and Laboratory Test Findings a)Hepatitis B surface antigen-positive subjects. b) Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR positive. c)Subjects with any of the following laboratory values: i)Hgb < 8.5 g/dL. ii)WBC < 3,000/mm3 (3 x 109/L) iii)Platelets < 100,000/mm3 (100 x 109/L). iv)Serum creatinine > 2 times upper limit of normal. v)Serum ALT or AST > 2 times upper limit of normal. vi)Any other laboratory test results that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. 4.Allergies and Adverse Drug Reaction a)None 5.Prohibited Treatments and/or Therapies a)Subjects who have had prior exposure to abatacept(CTLA4-Ig) b)Subjects who have been exposed to any investigational drug within 4 weeks or 5 half-lives,whichever is longer.c) Subjects currently(or in the last 3 months)receiving treatment with azathioprine,gold,leflunomi


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073
Intervention(s)

Product Name: Abatacept
Product Code: BMS188667
Pharmaceutical Form: Solution for injection
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: METHOTREXATE HOSPIRA 2.5 mg tablety
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The 2 co-primary objectives for this study will compare the clinical efficacy of abatacept in combination with methotrexate to methotrexate alone on the following: 1) The proportion of randomized and treated subjects with DAS28-CRP < 2.6 at Month 12. 2) The proportion of randomized and treated subjects with DAS28-CRP < 2.6 at both Month 12 and Month 18
Primary end point(s): The co-primary endpoints are: 1) The proportion of randomized and treated subjects in remission (DAS28-CRP < 2.6) at Month 12 in the Treatment Period 2) The proportion of randomized and treated subjects in remission at both Month 12 and Month 18
Secondary Objective: 1) Assess physical function and health-related quality of life using HAQ and SF-36 (V2.0) in the abatacept/MTX combination, abatacept monotherapy, and MTX monotherapy arms 2) Assess joint damage progression by MRI scoring at Months 6, 12, 18, and 24 in the abatacept/MTX combination, abatacept monotherapy, and MTX monotherapy arms 3) Assess safety and tolerability including immunogenicity in the abatacept/MTX combination, abatacept monotherapy, and MTX monotherapy arms. 4) Assess the proportion of randomized and treated subjects in the abatacept monotherapy arm with a) DAS28-CRP < 2.6 at Month 12 and b) subjects with DAS28-CRP < 2.6 at both Month 12 and Month 18
Secondary Outcome(s)
Secondary ID(s)
2010-018674-20-FR
IM101-226
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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