rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.
Conditions
Interventions
Trade Name: Enbrel
Product Name: etanercept
Pharmaceutical Form: Injection
Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Injection
Trade Name: Cimzia
Product Name: certolizumab pe
Sponsors
READE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria phase 1: • Patients with RA, PsA, AS or Pso treated with a first TNF inhibitor (adalimumab, infliximab, etanercept, golimumab or certolizumab pegol) in daily clinical practice across different European countries; • TNF inhibitor treatment has been initiated and continued until failure at dose and interval according to label* • Inefficacy of first TNF inhibitor (both ‘primary’ and ‘secondary’ failure) resulting in switch of therapy; • Planned treatment with a second TNF inhibitor; • Written informed consent; *adalimumab 40 mg every other week; etanercept 50 mg once weekly or 25 mg twice weekly; golimumab 50 mg once monthly, certolizumab 200 mg every other week; infliximab 3 mg/kg / 8 weeks (RA); infliximab 5 mg/kg / 6-8 weeks (AS); infliximab 5 mg/kg / 8 weeks (PsA or Pso); Inclusion criteria phase 2: • Participation in phase 1; • First TNF inhibitor treatment is switched to second TNF inhibitor treatment (at labelled dose) 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 1550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Exclusion criteria phase 1: • Current TNF inhibitor treatment is not the first TNF inhibitor ever used for this patient; • First TNF inhibitor treatment switched due to other reasons than inefficacy (e.g. side effects) • Serum sample not taken at trough Exclusion criteria phase 2: • Treatment is switched to other treatment than TNF inhibitor • Serum sample not taken at trough (for definition see ‘trough sample definitions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To create a database containing European wide data on immunogenicity and disease activity in daily clinical practice and to explore influencing factors of immunogenicity and disease activity. 1) To determine the proportion of patients developing ADA detectable with an antigen binding test (ABT, radioimmunoassay) in patients experiencing inefficacy of their first TNF inhibitor treatment. (Phase 1)* 2) To study response to a subsequent TNF inhibitor treatment after patients experienced inefficacy of a first TNF inhibitor. (Phase 2)* 3) To investigate the predictive value of ADA and drug levels for response to subsequent TNF inhibitor treatment. (Phase 1 and 2);Secondary Objective: NOT APPLICABLE;Primary end point(s): Primary endpoint Phase 1: Amongst patients that perceive inefficacy of their first TNF inhibitor, the percentage of patients that test positive for anti-drug antibodies, detectable with a radioimmunoassay;Timepoint(s) of evaluation of this end point: MONTH 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Endpoints in Phase 2 (6 months) RA: primary: minimal disease activity (DAS28 < 2.6). Secondary: SDAI remission. AS: primary: ASDAS, inactive disease (<1.3). Secondary: ASDAS, minimal disease activity (<2.1); BASDAI50 response. PsA: primary: minimal disease activity*. Secondary: ACR 20, 50, 70. Pso: primary: PASI 75. Secondary: PASI 50; PASI 90 * MDA is defined as a score of at least 5 out of 7 from the following outcome measures: TJC (0-68) =1, SJC (0-66) =1, PASI =3, patient pain VAS =15 (scale 0-100), patient global disease activity VAS =15 (scale 0-100); HAQ score =0.5, and tender entheseal points =1(using Leeds Enthesitis Index, LEI).;Timepoint(s) of evaluation of this end point: MONTH 6 | — |
Countries
Finland
Contacts
Public ContactPRINCIPAL INVESTIGATOR
READE
Outcome results
None listed