Condition category
Musculoskeletal Diseases
Date applied
14/10/2010
Date assigned
09/11/2010
Last edited
24/03/2011
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 Maurice Barry

ORCID ID

Contact details

Dept of Rheumatology
Connolly Hospital
Blanchardstow
Dublin
15
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 2

Study information

Scientific title

Randomised controlled trial of etanercept and methotrexate in very early rheumatoid arthritis with sustained remission after etanercept withdrawal

Acronym

Study hypothesis

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

Connolly Hospital Ethics Board

Study design

Randomised open label pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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 Combination of methotrexate and etanercept 50mg once weekly for 24 weeks; etanercept is withdrawn at 24 weeks if the patient is in remission with DAS28 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/07/2006

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/07/2006

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Ireland

Trial participating centre

Dept of Rheumatology
Dublin
15
Ireland

Sponsor information

Organisation

Connolly Hospital (Health Service Executive [HSE]) (Ireland)

Sponsor details

Connolly Hospital
Blanchardstown
Dublin
15
Ireland

Sponsor type

Hospital/treatment centre

Website

http://www.connollyhospital.ie

Funders

Funder type

Industry

Funder name

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

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