Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND

Conditions: RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

Registration Number: EUCTR2009-017379-90-IT

Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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