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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: 14 September 2015
Main ID:  EUCTR2009-017379-90-IT
Date of registration: 31/03/2010
Prospective Registration: Yes
Primary sponsor: AZIENDA OSPEDALIERA SENESE
Public title: Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND
Scientific title: Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND
Date of first enrolment: 27/04/2010
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017379-90
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: Placebo: Other:  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1.Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed 2.Males and females >= 18 years of age 3.RA patients fulfilling the 1987 ACR criteria 4.Prior discontinuation of a first TNF-blocker monoclonal antibody (Infliximab or Adalimumab) for secondary inefficacy (or Loss of response) defined as: responder (DAS28 improvement from start of first TNF-i >1.2) at 6 months but non-responder (DAS28 improvement from start of first TNF-i <1.2) at any time point thereafter. 5.Female subjects must avoid any pregnancy during the Etanercept administration period and for 6 months afterward
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.DAS28 < 3.2 2.Previous Etanercept treatment 3.Patient na?ve to DMARDs and to TNF-i 4.Sepsis or risk of sepsis 5.Current or recent infections, including chronic or localized 6.Previous clinical trial involvement in last 3 months 7.Concomitant live viral or bacterial vaccines 8.Hemoglobin =85 g/L; 9.Platelet count =125 x 109 /L; 10.White blood cell count =3.5 x 109/L; 11.Serum creatinine =175 ?mol/L; 12.Increased LFTs.> 2 x upper limit 13.Pre-existing or recent onset CNS demyelinating disease 14.Malignancy within 5 years prior to study start 15.Women pregnant or breastfeeding 16.Any clinically significant medical or surgical condition that in the investigator s opinion would compromise the ability of the patient to participate in/complete the trial or the outcome of the study or could place the patient at undue risk


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Intervention(s)

Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)
Main Objective: Efficacy of Etanercept as improvement in DAS28 at final assessment comparing to baseline
Primary end point(s): Proportion of subjects with improvement >1.2 Units in DAS 28 at 24 weeks comparing to baseline
Secondary Objective: Further efficacy data evaluation of Etanerpect as changes in DAS28, CDAI, SDAI, QofL and tolerability
Secondary Outcome(s)
Secondary ID(s)
TNF-block
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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