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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-000129-47-SE
Date of registration:	25/02/2005
Prospective Registration:	Yes
Primary sponsor:	Dept. of Rhematology UMAS
Public title:	The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.
Scientific title:	The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.
Date of first enrolment:	21/03/2005
Target sample size:	15
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000129-47
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes 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: yes Other specify the comparator: Before and after 3 months treatment
Phase:

Countries of recruitment
Sweden

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
Patients with rheumatoid arthritis wich are planned to be treated with adalimumab (Humira) because of severe disease activity.Previously nonresponder on one DMARD. At the time of inclusion at least 6 swollen joints in 28-joint index protocoll and CRP more than 8 mg/L.

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:
Anti-TNF treatment for the last three months.
Highdose peroral cortison (>= 20 mg daily) or has been treated with intravenous cortison two weeks before inclusion.

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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis.

Intervention(s)

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective:

Main Objective: Does anti-inflammatory treatment with adalimumab (Humira) reduce endothelial activation in active rheumatoid arthritis (RA)?
Immunohistochemical markers of endothelial activation in skeletal muscles and common carotid artery intima-media thickness will be evaluated.

Primary end point(s): Decrease of endotelial expression of HLA-DQ and IL1-alpha in muscle biopsies and common carotid artery intima-media thickness after three months of treatment.

Secondary Outcome(s)

Secondary ID(s)

REUMAUMAS 2005-1

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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