Prospective study on the effects of rituximab on synovial tissue of patients with rheumatoid arthritis

ISRCTN	ISRCTN05568900
DOI	https://doi.org/10.1186/ISRCTN05568900
Secondary identifying numbers	NTR851

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 03/10/2008

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 Koen Vos
Scientific

Academic Medical Centre (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 2171
Email	K.Vos@amc.uva.nl

Study information

Study design	Prospective open-labelled study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Rituximab II AMC study
Study objectives	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(s)	Received from the Medical Ethics Committee of the Academic Medical Center, University of Amsterdam on the 25th March 2005 (ref: 05/038).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/03/2005
Completion date	01/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	32
Key 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
Key exclusion criteria	1. Previous treatment with rituximab 2. Intra-articular or parenteral corticosteroids within four weeks prior to inclusion
Date of first enrolment	01/03/2005
Date of final enrolment	01/03/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

Dutch Arthritis Association (Reumafonds) (The Netherlands)

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	01/07/2008		Yes	No