The efficacy and safety of intra-articular injections with the tumour-necrotising factor alpha (TNFa) antagonist infliximab in patients with chronic or recurrent arthritis of the knee
| ISRCTN | ISRCTN17726268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17726268 |
| Secondary identifying numbers | P04-139 |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 07/01/2021
- 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
Dr A E van der Bijl
Scientific
Scientific
Leiden University Medical Centre
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5263598 |
|---|---|
| a.e.van_der_bijl@lumc.nl |
Study information
| Study design | Randomised double blinded, active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The efficacy and safety of intra-articular injections with the tumour-necrotising factor alpha (TNFa) antagonist infliximab in patients with chronic or recurrent arthritis of the knee |
| Study objectives | The systemic treatment of rheumatoid arthritis with anti-tumour necrotising factor alpha (anti-TNFa) is very successful. In a number of case reports varying success rates of intra-articular injections with the TNFa blocking agent infliximab have been reported. In this study we want to assess the safety and efficacy of intra-articular injections with infliximab in patients with relapsing or persistent (mono-) arthritis of the knee. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Arthritis, spondyloarthropathy, rheumatoid arthritis |
| Intervention | Treatment with infliximab 100 mg intra-articular or methylprednisolone 80 mg intra-articular. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Infliximab |
| Primary outcome measure | Recurrence or persistence of knee arthritis as defined by either: 1. The need for local therapy such as joint aspiration or injection, arthroscopy or (radio-) synovectomy 2. Non-improvement of knee joint score |
| Secondary outcome measures | Clinical parameters: 1. The occurrence of (systemic) side effects 2. Physician's assessment of local disease activity as measured by joint swelling as well as pain 3. Patient's functional status measured by a Health Assessment Questionnaire (HAQ) 4. Patient's Visual Analogue Scales (VAS) for local and general pain and overall disease activity 5. Physician's assessment of overall disease activity (VAS) 6. Disease Activity Score (DAS28) 7. Morning stiffness 8. A five-point global assessment scale measuring improvement or deterioration compared to baseline and the previous assessment Laboratory parameters: Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and immunoglobulin M (IgM) rheumatoid factor titre Radiological parameters: Magnetic Resonance Imaging (MRI) quantification of the synovial tissue volume (blinded and at random order) |
| Overall study start date | 16/09/2004 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Inflammatory arthritis involving a knee (rheumatoid arthritis, juvenile chronic arthritis, spondylarthropathies and arthritis of unknown origin) 2. Aged above 18 years 3. Written informed consent 4. At least two therapeutic corticosteroid injections in the affected joint within a period of one year |
| Key exclusion criteria | 1. Haemorrhagic disease 2. Arthritis due to infection, gout or osteoarthritis 3. Participation in any other study which interferes with or is influenced by this study 4. Use of oral prednisone in excess of 10 mg/day 5. Recent change of disease modifying anti-inflammatory drug (DMARD) therapy (six weeks or less) 6. Intra-articular injection with corticosteroid less than two months ago (concerning all joints) 7. Hypersensitivity to methylprednisolone/triamcinolone, lidocain or infliximab (murine proteins) or intravenous (iv) contrast 8. Active/latent tuberculosis 9. Acute/chronic infection 10. Multiple sclerosis 11. Decompensation cordis (New York Heart Association [NYHA] classification III and IV) 12. Pregnancy or lactating females 13. Malignancy 14. Claustrophobia 15. Pacemaker in situ/metal prostheses and/or vascular clips |
| Date of first enrolment | 16/09/2004 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Rheumatology
PO Box 9600 RC
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 | 15/07/2009 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference added.
