The rationale for this study is to gain insight in the extent and impact of immunogenicity of TNF inhibitors in the European daily clinical practice. Furthermore, an European wide database will give insight in factors influencing immunogenicity and treatment outcome in terms of disease activit

• Register: EUCTR
• Last refreshed on: 28 September 2015
• Main ID: EUCTR2015-002284-42-FI
• Date of registration: 28/08/2015
• Prospective Registration: Yes
• Primary sponsor: READE
• Public title: The rationale for this study is to gain insight in the extent and impact of immunogenicity of TNF inhibitors in the European daily clinical practice. Furthermore, an European wide database will give insight in factors influencing immunogenicity and treatment outcome in terms of disease activit
• Scientific title: INTENT: immunogenicity in patients failing response on anti-TNF -Immunogenicity and pharmacokinetics in patients failing to respond to TNF inhibitors (phase 1); -Clinical effectiveness of subsequent TNF inhibitor treatment and predictive value of pharmacokinetics and immunogenicity (phase 2) - INTENT
• Date of first enrolment: 18/09/2015
• Target sample size: 1650
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002284-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Finland

Contacts

• Name: PRINCIPAL INVESTIGATOR
• Affiliation: READE

• Name: PRINCIPAL INVESTIGATOR
• Affiliation: READE

Key inclusion & exclusion 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 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.

Therapeutic area: Not possible to specify

Intervention(s)

Trade Name: Enbrel
Product Name: etanercept
Pharmaceutical Form: Injection

Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Injection

Trade Name: Cimzia
Product Name: certolizumab pegol
Pharmaceutical Form: Injection

Trade Name: Simponi
Product Name: golimumab
Pharmaceutical Form: Injection

Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Infusion

Primary Outcome(s)

Secondary Objective: NOT APPLICABLE

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)

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 Outcome(s)

Timepoint(s) of evaluation of this end point: MONTH 6

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).

Secondary ID(s)

NL51186.048.14

Source(s) of Monetary Support

PFIZER