Intramuscular depomedrone in very early inflammatory polyarthritis
| ISRCTN | ISRCTN69908361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69908361 |
| Secondary identifying numbers | S0671 |
- Submission date
- 05/02/2002
- Registration date
- 05/02/2002
- Last edited
- 23/08/2011
- 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
Professor Deborah Symmons
Scientific
Scientific
ARC Epidemiology Unit
University of Manchester
Manchester
M13 9PT
United Kingdom
| Phone | +44 (0)161 275 5037 |
|---|---|
| deborah.symmons@fs1.ser.man.ac.uk |
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STIVEA |
| Study objectives | That treating patients with very early inflammatory polyarthritis (less than 10 weeks duration) with a three week course of IM steroid will prevent a substantial proportion of cases from evolving into rheumatoid arthritis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Inflammatory polyarthritis |
| Intervention | Patients will be randomised to receive: 1. Either weekly injections of 80 mg depomedrone (methylprednisolone) deep into the gluteal muscles for 3 weeks 2. Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Depomedrone (active ingredient: methylprednisolone) |
| Primary outcome measure | The need to start second-line drug therapy (e.g. methotrexate, sulphasalazine) by the 6 month assessment. |
| Secondary outcome measures | 1. Whether the patient has satisfied classification criteria for rheumatoid arthritis 2. The presence of radiological erosions in the hands or feet at 12 months 3. The change in physical disability and clinical diagnosis |
| Overall study start date | 01/06/2003 |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 346 |
| Key inclusion criteria | Patients aged 18 years or more with inflammatory polyarthritis with a duration of 4 - 10 weeks. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ARC Epidemiology Unit
Manchester
M13 9PT
United Kingdom
M13 9PT
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No |
