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
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
-
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.