Evaluation of serum levels of chemokines during interferon beta treatment in multiple sclerosis patients
| ISRCTN | ISRCTN45526724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45526724 |
| Protocol serial number | Serum chemokines and multiple sclerosis number 1 |
| Sponsor | Foundation to Support Education, Research and Assistance (Fundação de Apoio ao Ensino, Pesquisa e Assistência [FAEPA]) (Brazil) |
| Funders | 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, Bayer Schering (Brazil) - Chemokine kits were bought using funds from a unconditional grant |
- 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
Scientific
Avenida Bandeirantes 3900
Ribeirão Preto
14049-900
Brazil
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
Comparison of serum chemokines levels with patients and disease characteristics |
| Key secondary outcome measure(s) |
Comparison of serum chemokines levels with lesions by magnetic resonance imaging (MRI) |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
14049-900
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
