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Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2010-020913-10-GB
Date of registration:	23/07/2010
Prospective Registration:	Yes
Primary sponsor:	Norfolk & Norwich University Hospitals NHS Foundation Trust
Public title:	An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERS
Scientific title:	An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERS
Date of first enrolment:	11/08/2010
Target sample size:	50
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020913-10
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes 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: yes Other specify the comparator: Enbrel 50mg solution for injection in prefilled syringe (etanercept) - EU/1/99/126/015-18
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
At screening / baseline
The participant will be placed on Etanercept 50mg once weekly providing:
a) Diagnosis of AS according to the modified New York criteria (Study Protocol, Appendix 1).
b) Confirmation of sustained active spinal disease, demonstrated by:
i. BASDAI score of at least 4 units (Study Protocol, Section 5.6)
ii. At least 4 cm on a 0-10cm spinal pain visual analogue scale (VAS)
iii. Both severity measures demonstrated on two occasions at least 12 weeks apart without any change of treatment
c) Conventional treatment with two or more NSAIDs taken sequentially at maximum tolerated or recommended dosage for 4 weeks have failed to control symptoms.
d) Participant has clinically acceptable results from laboratory screening test.
e) Male or Female, aged 18 – 80 years
f) Participant is willing and able to give informed consent to participate in the study.
g) Able (in the Investigators opinion) and willing to comply with all study requirements.

At randomisation
The participant will be randomised to 50mg or 25mg Etanercept providing:
a) An adequate response to treatment has been achieved, with response defined as:
i. reduction of the BASDAI score to 50% of the pre-treatment value OR
ii. reduction in BASDAI by 2 or more units AND
iii. reduction of the spinal pain VAS by 2 cm or more.
b) The participant finds Etanercept acceptable and wishes to continue treatment

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:
At screening / baseline: the participant will not enter the study if ANY of the following apply:
a) Previous treatment with any licensed or experimental anti TNF therapy.
b) Chronic infection of the upper respiratory tract (e.g. sinusitis), chest (e.g. bronchiectatic lung disease), urinary tract or skin (e.g. paronychia, chronic ulcers, open wounds).
c) Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months.
d) Any ongoing or active infection or any major episode of infection requiring hospitalisation or treatment with intravenous (IV) antibiotics within the preceding 30 days and/or orally administered antibiotics in the preceding 15 days.
e) Received any live (attenuated) vaccines within four weeks of screening visit.
f) Known immunosuppressive disease or treatment with immunosuppressive drugs.
g) Active / latent tuberculosis as identified by local screening guidelines.
h) Stable corticosteroid use =10mgs OD taken in the 4 weeks prior to screening.
i) History of hepatitis B or C.
j) Significant concurrent cardio-vascular disease including; uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension.
k) Cancer or a history of cancer (other than resected cutaneous basal cell carcinoma, and in situ cervical cancer) within five years of entering the screening period.
l) Significant renal or hepatic impairment.
m) Leukopaenia (wbc <3000 x 10^6/L) and/or neutropeania (wbc =1500 x 10^6/L).
n) Thrombocytopaenia (platelets less than 150 x 10^9/L).
o) Demyelinating disorders such as multiple sclerosis.
p) Women who are pregnant, lactating or of childbearing potential not using contraception.
q) Scheduled elective surgery/procedures requiring general anaesthesia during the study.
r) Allergy to latex (the needle cover of the syringe contains latex).
s) Presence of any other significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of Etanercept
t) Unable to give informed consent
u) Unable/unwilling to comply with study procedures.
v) Not available for follow-up assessments
w) Received treatment with an investigational drug within 12 weeks prior to study screening.
x) History of back injury or trauma which confounds the clinical scenario

At randomisation: the participant will not be randomised if ANY of the following apply:
a) An adequate response to Etanercept 50mg per week has not been achieved by the end of the 6 month lead in period.
b) The participant wishes to discontinue treatment with Etanercept.
c) On the basis of adverse reactions, the treating physician considers the participant should withdraw from treatment with Etanercept.

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

Health Condition(s) or Problem(s) studied

Ankylosing spondylitis

Intervention(s)

Trade Name: Enbrel®
Product Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

Secondary Objective: To assess additional measurements of efficacy and adverse effects in low and high dose groups.

Primary end point(s): The primary efficacy outcome measure will be:
• 50% reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
AND/OR
• Fall in BASDAI by >/= 2 units.

Main Objective: To investigate whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with ankylosing spondylitis who have responded to 50mg once weekly.

Secondary Outcome(s)

Secondary ID(s)

ANS/4.3

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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