Condition category
Musculoskeletal Diseases
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
22/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A E van der Bijl

ORCID ID

Contact details

Leiden University Medical Centre
Department of Rheumatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5263598
a.e.van_der_bijl@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P04-139

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised double blinded, active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Infliximab

Primary outcome measures

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 trial start date

16/09/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

16/09/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes