Condition category
Musculoskeletal Diseases
Date applied
05/02/2002
Date assigned
05/02/2002
Last edited
23/08/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Deborah Symmons

ORCID ID

Contact details

ARC Epidemiology Unit
University of Manchester
Manchester
M13 9PT
United Kingdom
+44 (0)161 275 5037
deborah.symmons@fs1.ser.man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S0671

Study information

Scientific title

Acronym

STIVEA

Study hypothesis

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

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Depomedrone (active ingredient: methylprednisolone)

Primary outcome measures

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 trial start date

01/06/2003

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 years or more with inflammatory polyarthritis with a duration of 4 - 10 weeks.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

346

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/2003

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ARC Epidemiology Unit
Manchester
M13 9PT
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19825849

Publication citations

  1. Results

    Verstappen SM, McCoy MJ, Roberts C, Dale NE, Hassell AB, Symmons DP, , Beneficial effects of a 3-week course of intramuscular glucocorticoid injections in patients with very early inflammatory polyarthritis: results of the STIVEA trial., Ann. Rheum. Dis., 2010, 69, 3, 503-509, doi: 10.1136/ard.2009.119149.

Additional files

Editorial Notes