ABIRISK_MS_Retrospective
Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk
groups: IMI Projects
tags: IMI Translational Medicine
- First Name
- Pierre
- Last Name
- Dönnes
- Affiliation
- SciCross AB
- pierre@scicross.com
- Business Phone Number
- 46703919310
- Business Fax Number
- -
- Business Address
- -
- Project Website
- http://www.abirisk.eu
- Version
- 1
- Date of creation of the dataset
- 2016-01-01
- Date of the last update of the dataset
- 2016-07-01
- Funding
- IMI
- Reference Publications
- http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0162752
- Data Standards Implemented
- -
- Therapeutic Area Standards (Disease Area)
- MS
- Study Protocal Description
- Clinical and anti-drug antibody data from 4 european countries
- Multi-center Study
- True
- Description of Cohorts
- Data collected in Sweden, Austria, Germany and Denmark
- Study Type
- OBSERVATIONAL
- Study Type Comment
- -
- Primary Purpose
- Association of ADA to clinical variables.
- Study Phase
- On market
- Intervention Model
- -
- Study Classification
- -
- Indication
- -
- Age Range (Low Limit) of Study
- -
- Age Range (Upper Limit) of Study
- -
- Age Unit (of the above ranges)
- -
- BMI Range
- -
- BMI Range (lower limit)
- -
- BMI Range (upper limit)
- -
- Informed Consent
- True
- Planned Arm (Description of Sub-cohorts)
- -
- Name of Treatment
- -
- Standardized Name of Treatment
- -
- Category
- -
- Dose Description
- -
- Organism
- Homo sapiens
- Body System or Organ Class
- -
- Total Number of (Human) Subjects
- 20465
- Total Number of (Non-Human) Subjects
- 20465
- Number of Subjects in Each Cohorts (if multi-cohorts)
- -
- Detail Subject Composition
- -
- Type of Samples Collected
- Serum
- Number of Samples Collected
- -
- Samples Details
- -
- Secondary Analysis
- Antidrug antibody assessment