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
Protocol serial number	P04-139
Sponsor	Leiden University Medical Centre (LUMC) (The Netherlands)
Funder	Not provided at time of registration

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

Leiden University Medical Centre
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5263598
Email	a.e.van_der_bijl@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised double blinded, active controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Infliximab
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.