Evaluation of serum levels of chemokines during interferon beta treatment in multiple sclerosis patients

ISRCTN	ISRCTN45526724
DOI	https://doi.org/10.1186/ISRCTN45526724
Secondary identifying numbers	Serum chemokines and multiple sclerosis number 1

Submission date: 02/12/2010
Registration date: 21/01/2011
Last edited: 07/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eduardo Donadi
Scientific

Avenida Bandeirantes 3900
Ribeirão Preto
14049-900
Brazil

Study information

Study design	Longitudinal observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Longitudinal evaluation of serum chemokine levels in multiple sclerosis patients treated with interferon beta
Study objectives	Association of serum chemokines with age, gender, time of disease, disability, lesions on magnetic ressonance, and treatment in patients with multiple sclerosis
Ethics approval(s)	The Ethics Committee of the Ribeirão Preto School of Medicine, University of São Paulo approved on the 22nd May 2006 (ref: 3820/2006)
Health condition(s) or problem(s) studied	Multiple sclerosis
Intervention	Blood samples were taken 7 times each other month for one year. Clinical evaluation, EDSS score and imaging by magnetic ressonance at the initial and final evaluation.
Intervention type	Other
Primary outcome measure	Comparison of serum chemokines levels with patients and disease characteristics
Secondary outcome measures	Comparison of serum chemokines levels with lesions by magnetic resonance imaging (MRI)
Overall study start date	01/07/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Patients with multiple sclerosis diagnosed by McDonald criteria 2001 2. Aged between 18 and 50 years old 3. Up to ten years of disease 4. Up to 5 points on the Expanded Disability Status Scale (EDSS) 5. At least one gadolinium enhacement lesion on magnetic ressonance or one clinical relapse in the year prior to study
Key exclusion criteria	1. Pregnancy 2. Ttreatment with immunossupressor regimen 3. Stability of disease more than one year
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Brazil

Study participating centre

Avenida Bandeirantes 3900

Ribeirão Preto
14049-900
Brazil

Sponsor information

Foundation to Support Education, Research and Assistance (Fundação de Apoio ao Ensino, Pesquisa e Assistência [FAEPA]) (Brazil)
Research organisation

Clinical Hospital
Ribeirão Preto School of Medicine
University of São Paulo
Avenida Bandeirantes 3900
Ribeirão Preto
14049-900
Brazil

Website	http://www.fmrp.usp.br

Funders

Funder type

Research organisation

Research and Teaching Support Foundation (Fundação de Amparo ao Ensino e Pesquisa e Assistência [FAEPA]) (Brazil) - Clinical Hospital, Ribeirão Preto School of Medicine, University of São Paulo

No information available

Bayer Schering (Brazil) - Chemokine kits were bought using funds from a unconditional grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2011		Yes	No