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
Protocol serial number	KF 02-064/02
Sponsor	The Parker Institute (Denmark)
Funders	Core grant from the Oak Foundation No. OUSA-01-030 (USA), Wyeth Inc. No. 0881A-101299 (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Henning Bliddal
Scientific

The Parker Institute
Frederiksberg Hospital
Frederiksberg
DK 2000
Denmark

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Etanercept 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) studied	Rheumatoid arthritis
Intervention	Intra-articular injection of 1. 25 mg Etanercept 2. 40 mg methylprednisolone
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Etanercept, glucocorticosteroid
Primary outcome measure(s)	1. Patient global evaluation of the joint treated 2. Independent joint evaluation by investigator
Key secondary outcome measure(s)	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)
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	38
Key inclusion criteria	Rheumatoid arthritis (RA), age >18 years, written informed consent, flare of RA in wrist, elbow, or knee joint
Key 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.
Date of first enrolment	01/09/2003
Date of final enrolment	31/12/2004

The Parker Institute

Frederiksberg
DK 2000
Denmark

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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