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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:  EUCTR2007-004241-15-IT
Date of registration: 27/06/2008
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb International Corporation
Public title: A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND
Scientific title: A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND
Date of first enrolment: 04/03/2008
Target sample size: 220
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004241-15
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: yes Other trial design description: Stratificato If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: - same IMP used at different dosage  
Phase: 
Countries of recruitment
Belgium France Germany Italy Netherlands Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1) Signed Written Informed Consent. 2) Target Population a) meet Classification Criteria for Psoriatic Arthritis (CASPAR) (Appendix 3) for a duration of disease at least 3 months; b) prior failure of DMARD therapy (inefficacy or intolerance); if patient had prior failure of methotrexate, s/he must have been on at least 15 mg/week dose for at least 2 months; c) if recent failure of a TNFα blockade compound (inefficacy or intolerance), must be washed out prior to first dose: 56 days for infliximab and 28 days for etanercept and adalimumab; d) disease activity as defined by a tender joint count of ≥ 3, swollen joint count of ≥ 3 and clinically detectable synovitis at screening and Day 01 (prior to infusion); e) have active psoriasis with a qualifying target lesion ≥ 2 cm in diameter; f) Must be able to have MRI performed. 3) Age and Sex a) Men and women (not nursing and not pregnant) ≥ 18 years of age at the time of informed consent; b) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of investigational product 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. Sex and Reproductive Status a) 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 dose of investigational product b) Women who are pregnant or breastfeeding, or plan to become pregnant, or to start breastfeeding during the duration of the study c) Women with a positive pregnancy test on enrollment or prior to investigational product administration. 2) Medical History and Concurrent Diseases a) Subjects who are scheduled for or anticipate joint replacement surgery. b) Subjects who have a recent history of clinically significant drug or alcohol abuse c) Concomitant illness that in the opinion of the Investigator, is likely to require systemic glucocorticosteroid therapy during the study (e.g.; moderate to severe asthma) d) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic 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 e) Subjects who are unwilling or unable to have screening performed based on current local or country guidelines/standards to evaluate the presence of cancer (e.g. breast, cervical, colon, prostate, hepatocellular, gastric). f) Subjects with a history or current evidence of malignancies; specifically, subjects with: a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection), or evidence of current malignancy or signs of possible malignancy detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded. Female subjects who have had a manual examination or breast cancer imaging (mammogram, ultrasound, other method) 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 (see Section 6.3.4). g) Subjects at risk for tuberculosis (TB). h) Subjects with any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis and bronchiectasis) i) 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). j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to signing informed consent k) Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time, during and for 3 months after the duration of the study. 3) Physical and Laboratory Test Findings a) Subjects with Hepatitis B surface antigen. b) Subjects with Hepatitis C antibody-positive subjects who are also RIBApositive 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 subj


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Psoriatic arthritis
MedDRA version: 9.1 Level: LLT Classification code 10032451 Term: Other rheumatoid arthritis with visceral or systemic involvement
Intervention(s)

Trade Name: ORENCIA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: abatacept
CAS Number: 332348-12-6
Current Sponsor code: BMS-188667
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: Double-Blind: To compare the efficacy of 3 regimens of abatacept vs. placebo in a 6-month double-blind study of psoriatic arthritis, as measured by the proportion of subjects achieving an ACR20 response (American College of Rheumatology 20% response) at Day 169. Open-label: To assess the safety and tolerability of abatacept treatment during the open-label extension phase (18 months after the initial 6-month, double-blind period).
Primary end point(s): Safety outcomes include adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug. Efficacy: The primary efficacy outcome measure for this study is an ACR20 response at study Day 169. A secondary objective of this study is to estimate the difference in proportion of subjects who achieve an IGA sc ore of clear or almost clear in each of the 3 abatacept arms compared to placebo at Day 169.
Secondary Objective: Double blind: 1. To estimate the difference in proportion of subjects achieving an Investigator Global Assessment (IGA) score of clear or almost clear in each of the 3 abatacept arms compared to placebo at Day 169. 2. To estimate the difference in mean percentage change from baseline in each of the 3 abatacept arms compared to placebo in target lesion scores at Day 169. 3. To estimate the difference in mean changes from baseline in physical and mental functions as measured by SF-36 in each of the 3 abatacept arms compared to placebo at Day 169 4. To estimate the difference in proportion of subjects with a diminution in disabilities as measured by HAQ scores between the 3 abatacept arms placebo at Day 169. 5. To describe the safety, tolerability, immunogenicity, and to predict the pharmacokinetics of each of the 3 abatacept arms using population pharmacokinetics (POPPK) methodology. Open-label: See section 2.3.2 of the protocol.
Secondary Outcome(s)
Secondary ID(s)
2007-004241-15-FR
IM101-158
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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