Remission induction study in early Rheumatoid Arthritis (RA)

ISRCTN	ISRCTN75505683
DOI	https://doi.org/10.1186/ISRCTN75505683
Secondary identifying numbers	Protocol version 2

Submission date: 14/10/2010
Registration date: 09/11/2010
Last edited: 24/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

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

Contact information

Dr Maurice Barry
Scientific

Dept of Rheumatology
Connolly Hospital
Blanchardstow
Dublin
15
Ireland

Study information

Study design	Randomised open label pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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 Combination of methotrexate and etanercept 50mg once weekly for 24 weeks; etanercept is withdrawn at 24 weeks if the patient is in remission with DAS28 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	Percentage of patients in DAS28 remission (<2.6) at 24 and 48 weeks
Secondary outcome measures	1. Percentage of patients achieving ACR20, 50 and 70 scores of improvement 2. Radiographic progression measured by the van der Heijde modified Sharp Score
Overall study start date	01/07/2006
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

Ireland

Study participating centre

Dept of Rheumatology

Dublin
15
Ireland

Sponsor information

Connolly Hospital (Health Service Executive [HSE]) (Ireland)
Hospital/treatment centre

Connolly Hospital
Blanchardstown
Dublin
15
Ireland

Website	http://www.connollyhospital.ie
"ROR"	https://ror.org/03h5v7z82

Funders

Funder type

Industry

Wyeth pharmaceuticals Ltd. (Ireland) - Unrestricted research grant for Dr. C Sheehy

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan