Second Line Agents in Myositis
| ISRCTN | ISRCTN40085050 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40085050 |
| Secondary identifying numbers | C0619 |
- Submission date
- 04/02/2002
- Registration date
- 04/02/2002
- Last edited
- 07/01/2021
- 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
Not provided at time of registration
Contact information
Dr Ernest Choy
Scientific
Scientific
Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
SE22 8PT
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 |
| Scientific title | Second Line Agents in Myositis |
| Study acronym | SELAM |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Inflammatory myositis |
| Intervention | Patients will be randomised to receive methotrexate, cyclosporin A, both or matching placebos |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methotrexate, cyclosporin A |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 10/03/2003 |
| Overall study end date | 30/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Total final enrolment | 58 |
| Participant inclusion criteria | Patients with inflammatory myositis |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 10/03/2003 |
| Recruitment end date | 30/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Department of Rheumatology
London
SE22 8PT
United Kingdom
SE22 8PT
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 | 01/06/2015 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.
