Induction of true remission in early poor prognosis (erosive) rheumatoid arthritis (RA) - a randomised study of methotrexate and intra-articular corticosteroids or placebo
| ISRCTN | ISRCTN14554919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14554919 |
| Protocol serial number | E0516 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (UK) |
- Submission date
- 15/07/2002
- Registration date
- 15/07/2002
- Last edited
- 03/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal 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 Paul Emery
Scientific
Scientific
Rheumatology and Rehabilitation Research Unit
University of Leeds
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
| Phone | +44 (0)113 233 4940 |
|---|---|
| p.emery@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Early rheumatoid arthritis |
| Intervention | 1. Receive combination therapy (n = 40) 2. Receive sulfasalazine (SSZ) alone (n = 42) |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 82 |
| Key inclusion criteria | 1. All patients to meet the American College of Rheumatology criteria for RA 2. Poor prognosis disease according to criteria based on the presence of factors known to be predictive of poor long-term outcome 3. Adequate contraception a prerequisite |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1995 |
| Date of final enrolment | 01/03/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9NZ
United Kingdom
LS2 9NZ
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? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/2000 | Yes | No |
