Intramuscular depomedrone in very early inflammatory polyarthritis

ISRCTN	ISRCTN69908361
DOI	https://doi.org/10.1186/ISRCTN69908361
Protocol serial number	S0671
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

Prof Deborah Symmons
Scientific

ARC Epidemiology Unit
University of Manchester
Manchester
M13 9PT
United Kingdom

Phone	+44 (0)161 275 5037
Email	deborah.symmons@fs1.ser.man.ac.uk

Primary study design	Interventional
Study design	Randomised placebo controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Depomedrone (active ingredient: methylprednisolone)
Primary outcome measure(s)	The need to start second-line drug therapy (e.g. methotrexate, sulphasalazine) by the 6 month assessment.
Key secondary outcome measure(s)	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
Completion date	01/06/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

ARC Epidemiology Unit

Manchester
M13 9PT
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	01/03/2010		Yes	No