Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/11/2014
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

Dr Christina Estrach

ORCID ID

Contact details

Specialist Registrar in Rheumatology
Rheumatology Unit
Whiston Hospital
Prescot
L35 5DR
United Kingdom
+44 (0)151 426 8270

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0237084064

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to assess whether the use of an integrated care pathway for the management of rheumatoid arthritis improves outcome. The care pathway attempts to optimise the treatment of RA incorporating all the features of current good practice. It sets out precise treatment decisions based on a validated disease activity score rather than decisions been made on an ad hoc basis by the staff reviewing the patient in out patients.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Rheumatoid arthritis (RA)

Intervention

Randomised to either the care pathway or conventional outpatient review before any changes to their DMARD therapy are made. The control group (50 subjects) will be the patients receiving standard rheumatological care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Larsen radiological score at 1 year and 2 years
2. Health Assessment Questionnaire (HAQ) assessment at baseline and every 6 months

Secondary outcome measures

1. Assessment of remission at 1 and 2 years
2. Number of DMARDs (disease-modifying anti-rheumatic drugs) and dosage at 1 and 2 years
3. Admissions to the ward with active RA during course of the study

Overall trial start date

15/08/2000

Overall trial end date

14/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients attending the Rheumatology service at St Helens & Knowsley NHS Hospitals with active RA, who are on no more than one disease-modifying anti-rheumatic drug (DMARD), will be invited to participate in the study. Inclusion criteria:
1. Patients with active inflammatory polyarthropathy
2. Age 18 or over
3. On no DMARDs or monotherapy
4. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 subjects - 50 to each arm of the study

Participant exclusion criteria

1. Inflammatory disease due to psoriatic arthritis or other clear or suspected cause other than RA
2. Pregnancy at the time of enrolment or planned during the course of the next 3 years
3. On more than one DMARD at time of enrolment
4. Severe systemic disease or major co-morbidity

Recruitment start date

15/08/2000

Recruitment end date

14/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Specialist Registrar in Rheumatology
Prescot
L35 5DR
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

St Helens and Knowsley Hospitals NHS Trust (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

Publication citations

Additional files

Editorial Notes