Active management of rheumatoid arthritis (RA)

ISRCTN	ISRCTN78142229
DOI	https://doi.org/10.1186/ISRCTN78142229
Protocol serial number	N0237084064
Sponsor	Department of Health
Funder	St Helens and Knowsley Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Christina Estrach
Scientific

Specialist Registrar in Rheumatology
Rheumatology Unit
Whiston Hospital
Prescot
L35 5DR
United Kingdom

Phone	+44 (0)151 426 8270

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Larsen radiological score at 1 year and 2 years 2. Health Assessment Questionnaire (HAQ) assessment at baseline and every 6 months
Key secondary outcome measure(s)	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
Completion date	14/08/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	15/08/2000
Date of final enrolment	14/08/2003

Specialist Registrar in Rheumatology

Prescot
L35 5DR
United Kingdom

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