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
| ISRCTN | ISRCTN51200229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51200229 |
| Secondary identifying numbers | N0059111730 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simon Till
Scientific
Scientific
STH NHS Trust
Rheumatology
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with rheumatoid arthritis on standard disease modifying anti-rheumatic drugs (DMARD) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
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 |
Editorial Notes
05/02/2018: No publications found, verifying study status with principal investigator.
