Second Line Agents in Myositis

ISRCTN	ISRCTN40085050
DOI	https://doi.org/10.1186/ISRCTN40085050
Protocol serial number	C0619
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ernest Choy
Scientific

Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Second Line Agents in Myositis
Study acronym	SELAM
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Inflammatory myositis
Intervention	Patients will be randomised to receive methotrexate, cyclosporin A, both or matching placebos
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methotrexate, cyclosporin A
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/03/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Total final enrolment	58
Key inclusion criteria	Patients with inflammatory myositis
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/03/2003
Date of final enrolment	30/03/2005

Academic Department of Rheumatology

London
SE22 8PT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2015	07/01/2021	Yes	No

07/01/2021: Publication reference and total final enrolment added.