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
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETANERCEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.DAS28 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of Etanercept as improvement in DAS28 at final assessment comparing to baseline;Secondary Objective: Further efficacy data evaluation of Etanerpect as changes in DAS28, CDAI, SDAI, QofL and tolerability;Primary end point(s): Proportion of subjects with improvement >1.2 Units in DAS 28 at 24 weeks comparing to baseline | — |
Countries
Italy
Outcome results
None listed