Contact information
Type
Scientific
Primary contact
Dr C.A. Wijbrandts
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology
F4-218
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2171
c.a.wijbrandts@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Exploratory study to investigate the effects of Tumour Necrotising Factor (TNF) targeted therapy with infliximab on the synovial cell infiltrate, and the induction of apoptosis.
Ethics approval
Ethics approval received from the Medical ethical committee of the Academic Medical Center/University of Amsterdam on the 1st October 2003 (ref: MEC 01/086).
Study design
Non-randomised, non-controlled, exploratory study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
Infliximab therapy (3 mg/kg intravenous [i.v.]) according to the normal regimen. At baseline and 1 hour (n = 5) or 24 hours (n = 5) after the first infliximab infusion synovial biopsies were obtained from an inflamed knee joint. Peripheral blood mononuclear cells were obtained before and 1 and 24 hours after infliximab infusion in 20 patients (10 only blood, 10 with paired synovial biopsies). Serum was drawn at similar timepoints.
Intervention type
Drug
Phase
Not Specified
Drug names
Infliximab
Primary outcome measure
1. Primary immunohistological outcome: detection of apoptosis in synovial tissue within 1 or 24 hours after initiation of treatment. Analysis by immunohistochemical staining and electron microscopy
2. Primary serological outcome: To determine whether TNF targeted therapy with infliximab results in apoptosis of peripheral blood mononuclear cells within 1 or 24 hours after initiation of treatment
Secondary outcome measures
To determine whether TNF targeted therapy with infliximab results in decreased synovial cellularity.
Overall trial start date
01/10/2003
Overall trial end date
01/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Rheumatoid Arthritis (RA) patients with active disease at baseline assessed by the Disease Activity Score (DAS-28)
2. Be more than or equal to 18 years of age
3. Use concurrent methotrexate treatment (7.5 - 30 mg/week; stable since greater than or equal to 28 days before initiation) during the study. Subjects may be taking non-steroidal anti-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy less than or equal to 10 mg/day provided that the dosage has been stable for at least a months prior to entry
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
1. Pregnancy
2. Breastfeeding
3. A history of or acute inflammatory joint disease of different origin, e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years
4. Acute major trauma
5. Previous therapy at any time with:
5.1. TNF-directed monoclonal antibodies
5.2. p75 TNF receptor fusion protein
6. Therapy within the previous 45 days with:
6.1. Any experimental drug
6.2. Alkylating agents, e.g. cyclophosphamide, chlorambucil
6.3. Anti-metabolites
6.4. Monoclonal antibodies
6.5. Growth factors
6.6. Other cytokines
7. Therapy within the previous 28 days with:
7.1. Parenteral or intraarticular corticoid injections
7.2. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily
7.3. Present use of Disease Modifying Anti-Rheumatic Drugs (DMARDs) other than methotrexate
8. Fever (orally measured greater than 38°C), chronic infections or infections requiring anti-microbial therapy
9. Manifest cardiac failure (stage III or IV according to New York Heart Association [NYHA] classification)
10. Progressive fatal disease/terminal illness
11. A hematopoietic disease
12. Body weight of less than 45 kg
Recruitment start date
01/10/2003
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Centocor Inc. (USA)
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
Basic results (scientific)
Publication list