A randomized, controlled study of intra-articular injections of etanercept or glucocorticosteroids in patients with rheumatoid arthritis
ISRCTN | ISRCTN97686858 |
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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
Scientific
The Parker Institute
Frederiksberg Hospital
Frederiksberg
DK 2000
Denmark
Phone | +45 38164151 |
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henning.bliddal@fh.hosp.dk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Etanercept, glucocorticosteroid |
Primary outcome measure | 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 study start date | 01/09/2003 |
Completion date | 31/12/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Denmark
Study participating centre
The Parker Institute
Frederiksberg
DK 2000
Denmark
DK 2000
Denmark
Sponsor information
The Parker Institute (Denmark)
Research organisation
Research organisation
Frederiksberg Hospital
Ndr Fasanvej 57
Frederiksberg
DK 2000
Denmark
Website | http://www.parkerinst.dk |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |