A randomized, controlled study of intra-articular injections of etanercept or glucocorticosteroids in patients with rheumatoid arthritis

ISRCTN ISRCTN97686858
DOI https://doi.org/10.1186/ISRCTN97686858
Secondary identifying numbers KF 02-064/02
Submission date
15/07/2005
Registration date
19/07/2005
Last edited
05/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Henning Bliddal
Scientific

The Parker Institute
Frederiksberg Hospital
Frederiksberg
DK 2000
Denmark

Phone +45 38164151
Email henning.bliddal@fh.hosp.dk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesEtanercept is more efficient than glucocorticosteroid for the treatment of synovitis when given intra-articularly
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRheumatoid arthritis
InterventionIntra-articular injection of
1. 25 mg Etanercept
2. 40 mg methylprednisolone
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Etanercept, glucocorticosteroid
Primary outcome measure1. Patient global evaluation of the joint treated
2. Independent joint evaluation by investigator
Secondary outcome measuresClinical: 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 study start date01/09/2003
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants38
Key inclusion criteriaRheumatoid arthritis (RA), age >18 years, written informed consent, flare of RA in wrist, elbow, or knee joint
Key exclusion criteriaSystemic 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.
Date of first enrolment01/09/2003
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Denmark

Study participating centre

The Parker Institute
Frederiksberg
DK 2000
Denmark

Sponsor information

The Parker Institute (Denmark)
Research organisation

Frederiksberg Hospital
Ndr Fasanvej 57
Frederiksberg
DK 2000
Denmark

Website http://www.parkerinst.dk
ROR logo "ROR" https://ror.org/05bpbnx46

Funders

Funder type

Industry

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2006 Yes No