Condition category
Musculoskeletal Diseases
Date applied
15/07/2005
Date assigned
19/07/2005
Last edited
05/11/2008
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

Prof Henning Bliddal

ORCID ID

Contact details

The Parker Institute
Frederiksberg Hospital
Frederiksberg
DK 2000
Denmark
+45 38164151
henning.bliddal@fh.hosp.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KF 02-064/02

Study information

Scientific title

Acronym

Study hypothesis

Etanercept is more efficient than glucocorticosteroid for the treatment of synovitis when given intra-articularly

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

Intra-articular injection of
1. 25 mg Etanercept
2. 40 mg methylprednisolone

Intervention type

Drug

Phase

Not Specified

Drug names

Etanercept, glucocorticosteroid

Primary outcome measures

1. Patient global evaluation of the joint treated
2. Independent joint evaluation by investigator

Secondary outcome measures

Clinical: Joint score for swelling and tenderness and HAQ, CRP, ESR, grip strength
Imaging:
Ultrasound Doppler pixel fraction
Ultrasound Doppler RI
Postcontrast magnetic resonance imaging (MRI)

Overall trial start date

01/09/2003

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Rheumatoid arthritis (RA), age >18 years, written informed consent, flare of RA in wrist, elbow, or knee joint

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant exclusion criteria

Systemic anti tumour necrosis factor (TNF) alpha therapy, had had intra-articular injection of steroids in the joint within 3 months, had skin lesions or other disease associated with increased risk of infection after injection, malignancy, severe heart, kidney, and/or lung disease, infections including human immunodeficiency virus (HIV), elevated alanine aminotransferase (ALT) (twice above the reference range), creatinine (>175 mmol/l), leucopenia (<3.5 x 10^9/l), thrombocytopenia (<125 x 10^9/l), or hemoglobin <8.5 g/dl, or allergy to the injected compounds. Women were excluded if pregnant, or of childbearing potential with an unacceptable birth control method.

Recruitment start date

01/09/2003

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Denmark

Trial participating centre

The Parker Institute
Frederiksberg
DK 2000
Denmark

Sponsor information

Organisation

The Parker Institute (Denmark)

Sponsor details

Frederiksberg Hospital
Ndr Fasanvej 57
Frederiksberg
DK 2000
Denmark

Sponsor type

Research organisation

Website

http://www.parkerinst.dk

Funders

Funder type

Industry

Funder name

Core grant from the Oak Foundation No. OUSA-01-030 (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wyeth Inc. No. 0881A-101299 (USA)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17062431

Publication citations

  1. Results

    Bliddal H, Terslev L, Qvistgaard E, Konig M, Holm CC, Rogind H, Boesen M, Danneskiold-Samsøe B, Torp-Pedersen S, A randomized, controlled study of a single intra-articular injection of etanercept or glucocorticosteroids in patients with rheumatoid arthritis., Scand. J. Rheumatol., 35, 5, 341-345, doi: 10.1080/03009740600844530.

Additional files

Editorial Notes