Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0059111730
Study information
Scientific title
Randomised double blind trial of safety of anti-tumour necrosis factor (anti-TNF) chimeric monoclonal antibody (infliximab) in combination with methatrexate compared to methatrexate alone in patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs
Acronym
Study hypothesis
Randomised double blind trial of safety of anti-tumour necrosis factor (TNF) chimeric monoclonal antibody (infliximab) in combination with methatrexate compared to methatrexate alone in patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Musculoskeletal Diseases: Rheumatoid arthritis (RA)
Intervention
Infliximab in combination with methatrexate compared to methatrexate alone.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Anti-tumour necrosis factor (TNF), chimeric monoclonal antibody (infliximab), methatrexate
Primary outcome measure
Currently unavailable
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/12/2001
Overall study end date
01/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs (DMARD)
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/12/2001
Recruitment end date
01/09/2003
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|