Remission induction study in early Rheumatoid Arthritis (RA)

ISRCTN	ISRCTN75505683
DOI	https://doi.org/10.1186/ISRCTN75505683
Protocol serial number	Protocol version 2
Sponsor	Connolly Hospital (Health Service Executive [HSE]) (Ireland)
Funder	Wyeth pharmaceuticals Ltd. (Ireland) - Unrestricted research grant for Dr. C Sheehy

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 Maurice Barry
Scientific

Dept of Rheumatology
Connolly Hospital
Blanchardstow
Dublin
15
Ireland

Primary study design	Interventional
Study design	Randomised open label pilot study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of etanercept and methotrexate in very early rheumatoid arthritis with sustained remission after etanercept withdrawal
Study objectives	The hypothesis of this study is that remission can be induced at higher rates when patients are treated with combination etanercept and methotrexate from baseline and that remission can be successfully maintained after withdrawal of etanercept.
Ethics approval(s)	Connolly Hospital Ethics Board
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	Two groups of 20 patients followed for 48 weeks initally. 1. Methotrexate only at dose of 20mg/week. 2. Combination of methotrexate and etanercept 50mg once weekly for 24 weeks; etanercept is withdrawn at 24 weeks if the patient is in remission with DAS28 <2.6. Patients seen at baseline, 4, 12, 24, 32 and 48 weeks.
Intervention type	Other
Primary outcome measure(s)	Percentage of patients in DAS28 remission (<2.6) at 24 and 48 weeks
Key secondary outcome measure(s)	1. Percentage of patients achieving ACR20, 50 and 70 scores of improvement 2. Radiographic progression measured by the van der Heijde modified Sharp Score
Completion date	31/12/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Age between 18-80 2. Fulfil 1987 American College of Rheumatology (ACR) classification criteria for RA 3. Active disease 3.1. At least 6 swollen and tender joints 3.2. Raised erythrocyte sedimentation rate (ESR) 3.3. C-reactive protein (CRP) 3.4. Prolonged early morning stiffness 4. Symptom duration between 6-52 weeks
Key exclusion criteria	1. Other type of inflammatory arthritis 2. Connective tissue disease 3. Pregnancy/lactation 4. Active tuberculosis (TB) 5. Pulmonary fibrosis 6. Chronic Kidney Disease, eGR<30mls/min 7. Chronic liver disease 8. History of malignancy treated within the last 5 years, ever diagnosed with melanoma 9. Septic arthritis 10. Chronic leg ulcers 11. Heart failure New York Heart Association (NYHA) class III or IV 12. Demyelinating disease
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2010

Dept of Rheumatology

Dublin
15
Ireland

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes