A study comparing the use of etanercept and methotrexate, used either alone or in combination for the treatment of Psoriatic Arthritis.

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2014-004869-24-CZ
• Date of registration: 21/12/2015
• Prospective Registration: No
• Primary sponsor: Amgen Inc.
• Public title: A study comparing the use of etanercept and methotrexate, used either alone or in combination for the treatment of Psoriatic Arthritis.
• Scientific title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis.
• Date of first enrolment: 18/12/2015
• Target sample size: 840
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004869-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Bulgaria, Canada, Chile, Czech Republic, France, Greece, Hungary, Latvia, Mexico, Poland, Portugal, Russian Federation, South Africa, Spain, United Kingdom, United States

Contacts

• Name: Medical Information
• Affiliation: Amgen (EUROPE) GmbH

• Name: Medical Information
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
•Subject must have a diagnosis of PsA by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
•Subject has = 3 tender and = 3 swollen joints at screening and at baseline.
•Subject has an active psoriatic skin lesion
•Subject is naïve to etanercept and any other biologic for the treatment for PsA or Psoriasis.
•Subject has no prior use of methotrexate for PsA.
•Subject has no history of tuberculosis
•Subject has a negative test for tuberculosis, hepatitis B and C
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 689
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 151

Exclusion criteria:
•Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including Human Immunodeficiency Virus infection.
•Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
•Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.


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

Health Condition(s) or Problem(s) studied

Psoriatic arthritis
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Methotrexate
Product Name: methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: methotrexate
CAS Number: 59-05-2
Current Sponsor code: methotrexate
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): American College of Rheumatology (ACR 20) response at week 24

Timepoint(s) of evaluation of this end point: ACR 20 response at week 24

Main Objective: To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology 20 response at week 24.

Secondary Objective: To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy as measured by the proportion of subjects achieving Minimal Disease Activity.
To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy on the following:
•Other measures of arthritis activity
•Measures of non-arthritic psoriatic arthritis disease activity
•Key patient reported outcomes related to physical function and quality of life

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: • Minimal Disease Activity (MDA) response of arthritis activity at week 24
•Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity at week 24
•Minimal Disease Activity (MDA) response of patient reported outcomes at week 24.

Secondary end point(s): To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy on the following:
•Other measures of arthritis activity
•Measures of non-arthritic PsA disease activity
•Key patient reported outcomes (PRO) related to physical function and quality of life

Secondary ID(s)

2014-004869-24-LV

20130207

Source(s) of Monetary Support

Amgen Inc

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 15/07/2019
• Date Completed: 06/07/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004869-24/results