Condition category
Musculoskeletal Diseases
Date applied
15/07/2002
Date assigned
15/07/2002
Last edited
03/10/2007
Prospective/Retrospective
Retrospectively 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 Paul Emery

ORCID ID

Contact details

Rheumatology and Rehabilitation Research Unit
University of Leeds
36 Clarendon Road
Leeds
LS2 9NZ
United Kingdom
+44 (0)113 233 4940
p.emery@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

E0516

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Early rheumatoid arthritis

Intervention

1. Receive combination therapy (n = 40)
2. Receive sulfasalazine (SSZ) alone (n = 42)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1995

Overall trial end date

01/03/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients to meet the American College of Rheumatology criteria for RA
2. Poor prognosis disease according to criteria based on the presence of factors known to be predictive of poor long-term outcome
3. Adequate contraception a prerequisite

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

82

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1995

Recruitment end date

01/03/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9NZ
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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=10943871

Publication citations

  1. Results

    Proudman SM, Conaghan PG, Richardson C, Griffiths B, Green MJ, McGonagle D, Wakefield RJ, Reece RJ, Miles S, Adebajo A, Gough A, Helliwell P, Martin M, Huston G, Pease C, Veale DJ, Isaacs J, van der Heijde DM, Emery P, Treatment of poor-prognosis early rheumatoid arthritis. A randomized study of treatment with methotrexate, cyclosporin A, and intraarticular corticosteroids compared with sulfasalazine alone., Arthritis Rheum., 2000, 43, 8, 1809-1819, doi: 10.1002/1529-0131(200008)43:8<1809::AID-ANR17>3.0.CO;2-D.

Additional files

Editorial Notes