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 |
| Protocol serial number | N0059111730 |
| Sponsor | Department of Health (UK) |
| Funder | Sheffield Teaching Hospitals NHS Foundation Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Anti-tumour necrosis factor (TNF), chimeric monoclonal antibody (infliximab), methatrexate |
| Primary outcome measure(s) |
Currently unavailable |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
United Kingdom
S10 2JF
United Kingdom
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/02/2018: No publications found, verifying study status with principal investigator.
