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Register:	EUCTR
Last refreshed on:	25 November 2019
Main ID:	EUCTR2009-012424-87-GB
Date of registration:	14/10/2009
Prospective Registration:	Yes
Primary sponsor:	Imperial College London South Kensington London
Public title:	T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF
Scientific title:	T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF
Date of first enrolment:	26/11/2009
Target sample size:	55
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012424-87
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no 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
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:
- Anti-TNF naive patients
- Patients due to start treatment with anti-TNF blocking drugs - etanercept or adalimumab
- Patients with rheumatoid arthritis should meet the 1987 American College of Rheumatology (ACR) revised classification criteria, should have active rheumatoid arthritis as defined by a DAS28 score >5.1 and should be on a stable dose of disease-modifying drugs for the previous 1 month and a stable dose of glucocorticoids for at least 4 weeks prior to study entry.
-Patients with psoriatic arthritis should have a secure diagnosis confirmed by a rheumatologist and concurrent psoriatic skin lesions. If on disease-modifying therapy, patients should be on a stable dose for the the previous 1 month prior to study entry.
-Patients with ankylosing spondylitis should fulfill the Modified New York Criteria for diagnosis of ankylosing spondylitis and if taking disease-modifying therapy, they should be on a stable dose for the previous 1 month prior to study entry.
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:
- Patients who have been previously treated with anti-TNF therapy for whatever reason
- Patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who do not fulfill the diagnostic criteria for these conditions as above.
- Patients who have received an intra-articular injection of steroids or have received an intramuscular injection of depot steroid to treat disease flare in the preceding 4 weeks prior to commencing anti-TNF therapy.
- Patients with intercurrent, active infection of any type, excluding the common cold.

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

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis
MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis
MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis

Intervention(s)

Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Main Objective: The primary objective of our research is to determine the effect of anti-TNF-alpha treatment on the levels of a cell type of the immune system, called Th17 cells and their product, IL-17 in blood samples and joint biopsies from patients with rheumatoid arthritis at different time points during treatment and how these changes correlate with parameters of systemic and local disease activity.

Primary end point(s): TNF-alpha blockade will improve disease activity in patients with rheumatoid arthritis and this will correlate with a reduction in effector T cells and IL-17 in arthritic joints and an increase in effector T cells and IL-17 in peripheral blood.

There will be differences in cytokine expression and T cell populations in RA patients before and at different time points during anti-TNF treatment.

Secondary Objective: We would also like to determine the effect of anti-TNF-alpha treatment on levels on Th17 cells and IL-17 in other inflammatory conditions treated with anti-TNF therapies - psoriatic arthritis and ankylosing spondylitis and correlate these changes with systemic and local parameters of disease activity. This will help determine if anti-TNF treatment has similar or different effects on components of the immune system in the different conditions it is used to treat.

In addition we would like to determine the effects of anti-TNF-alpha therapy on various populations of immune system cells, called T cells and their products, called cytokines before and at different time points during treatment in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Secondary Outcome(s)

Secondary ID(s)

2104091

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
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