Contact information
Type
Scientific
Primary contact
Dr Koen Vos
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2171
K.Vos@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR851
Study information
Scientific title
Acronym
Rituximab II AMC study
Study hypothesis
Rituximab treatment leads to a decrease in synovial B cells. The clinical response is related to the decrease in synovial B cell numbers.
Ethics approval
Received from the Medical Ethics Committee of the Academic Medical Center, University of Amsterdam on the 25th March 2005 (ref: 05/038).
Study design
Prospective open-labelled 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
The patients underwent an arthroscopic synovial biopsy procedure directly before, and 4 and 16 weeks after receiving two infusions of rituximab without methylprednisolone premedication. Immunohistochemical analysis was performed on the synovial tissue.
Intervention type
Drug
Phase
Not Specified
Drug names
Rituximab
Primary outcome measure
To investigate the synovial tissue response to rituximab treatment and to identify possible predictors of clinical response in patients with Rheumatoid Arthritis (RA). RA patients undergo synovial biopsy before, 4, and 16 weeks after initiation of rituximab treatment without peri-infusional corticosteroids. Immunohistochemical analysis is performed and stained sections are analysed by digital image analysis. Statistical analysis is performed to find predictors of clinical response after 24 weeks.
Timepoints: one, four and six months after therapy.
Secondary outcome measures
1. To study the safety and effectivity of a fixed rituximab retreatment protocol
2. To study influence of rituximab on anti-drug antibody formation
3. To explore pharmacokinetic and pharmacodynamic effects in blood and synovial tissue
Timepoints: one, four and six months after therapy.
Overall trial start date
01/03/2005
Overall trial end date
01/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients (18 years or older) with rheumatoid arthritis (American College of Rheumatology [ACR] 1987 criteria) with active disease (at least 4/28 swollen and at least 4/28 painful joints, and either Erythrocyte Sedimentation Rate [ESR] 28 mm or C-Reactive Protein [CRP] 15 mg/l or morning stiffness for 45 minutes)
2. Rheumatoid factor and/or anti-Cyclic Citrullinated Peptide antibody (anti-CCP) positive
3. Stable doses of methotrexate (5 - 30 mg)
4. Stable doses of prednisone (0 - 10 mg)
5. Previous anti-Tumour Necrosis Factor (anti-TNF) treatment is allowed
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
32
Participant exclusion criteria
1. Previous treatment with rituximab
2. Intra-articular or parenteral corticosteroids within four weeks prior to inclusion
Recruitment start date
01/03/2005
Recruitment end date
01/03/2008
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
Research organisation
Funder name
Dutch Arthritis Association (Reumafonds) (The Netherlands)
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17965121
Publication citations
-
Results
Thurlings RM, Vos K, Wijbrandts CA, Zwinderman AH, Gerlag DM, Tak PP, Synovial tissue response to rituximab: mechanism of action and identification of biomarkers of response., Ann. Rheum. Dis., 2008, 67, 7, 917-925, doi: 10.1136/ard.2007.080960.