Condition category
Nervous System Diseases
Date applied
02/12/2010
Date assigned
21/01/2011
Last edited
07/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eduardo Donadi

ORCID ID

Contact details

Avenida Bandeirantes 3900
Ribeirão Preto
14049-900
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Serum chemokines and multiple sclerosis number 1

Study information

Scientific title

Longitudinal evaluation of serum chemokine levels in multiple sclerosis patients treated with interferon beta

Acronym

Study hypothesis

Association of serum chemokines with age, gender, time of disease, disability, lesions on magnetic ressonance, and treatment in patients with multiple sclerosis

Ethics approval

The Ethics Committee of the Ribeirão Preto School of Medicine, University of São Paulo approved on the 22nd May 2006 (ref: 3820/2006)

Study design

Longitudinal observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Pregnancy
2. Ttreatment with immunossupressor regimen
3. Stability of disease more than one year

Recruitment start date

01/07/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Brazil

Trial participating centre

Avenida Bandeirantes 3900
Ribeirão Preto
14049-900
Brazil

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.fmrp.usp.br

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22054120

Publication citations

  1. Results

    Comini-Frota ER, Teixeira AL, Angelo JP, Andrade MV, Brum DG, Kaimen-Maciel DR, Foss NT, Donadi EA, Evaluation of serum levels of chemokines during interferon-β treatment in multiple sclerosis patients: a 1-year, observational cohort study., CNS Drugs, 2011, 25, 11, 971-981, doi: 10.2165/11595060-000000000-00000.

Additional files

Editorial Notes