Condition category
Musculoskeletal Diseases
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
03/10/2008
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 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 measures

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

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

http://www.amc.uva.nl/

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17965121

Publication citations

  1. 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.

Additional files

Editorial Notes