Sjogren's SyndromePhase 1/2NCT00363350
Rituximab Treatment in Sjogren's Syndrome
A Phase 1/2 study testing rituximab (anti-CD20) in people with Sjogren's Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- rituximab (anti-CD20)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2006to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stimulated whole saliva secretion ≥ 0,15 ml/min
- Male or female > 18 years
- Primary SS according to the revised European - U.S. criteria(22)
- Positive autoantibodies (IgM-Rf > 10 and SS-A and/or SS-B)
- Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)
- Use of reliable method of contraception during the study
- Written informed consent
Who cannot join
- The presence of any other connective tissue disease
- Preceding treatment with anti-TNF or other monoclonal antibodies
- Use of prednisone, hydroxychloroquine less than 1 month ago
- Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago
- Serum creatine > 2.8 mg/dl (250 micromol/l)
- ASAT or ALAT outside 1.5 x upper normal range of the laboratory
Show all 14Show fewer
- Hb < 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
- Neutrophil granulocytes less than 0.5 x 109/l
- Platelet count less then 50 x 109/l
- Positive pregnancy test or breast-feeding
- History of alcohol or drug abuse
- Serious infections
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
- History of any malignancy with the exception of completely resected basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.
Read the detailed description
Study design:
phase II trial
Study objective:
evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS
Number of participating centres:
1
Duration:
follow-up 48 weeks
Study medication:
2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20
Primary objective/endpoint:
stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)
Secondary objectives/endpoint:
Functional parameters Laboratory parameters Subjective parameters Histological/Molecular parameters
Number of subjects:
30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo)
- Conditions
- Sjogren's Syndrome
- Being tested
- rituximab (anti-CD20)
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab (anti-CD20)Drug
Also called Mabthera
2 infusions of 1000 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
stimulated whole salivary flow rate
Measured: 48 weeks
Secondary outcomes (4)
Functional parameters
Measured: 48 weeks
Laboratory parameters
Measured: 48 weeks
Subjective parameters
Measured: 48 weeks
Histological/Molecular parameters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Jiska Meijer, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363350
- Sponsor's protocol ID
- METc2005.229
- Status last verified
- Feb 2009
- First submitted
- 10 Aug 2006
- Last updated
- 24 Feb 2009
- Results posted
- No
Publications
Pijpe J, van Imhoff GW, Spijkervet FK, Roodenburg JL, Wolbink GJ, Mansour K, Vissink A, Kallenberg CG, Bootsma H. Rituximab treatment in patients with primary Sjogren's syndrome: an open-label phase II study. Arthritis Rheum. 2005 Sep;52(9):2740-50. doi: 10.1002/art.21260.
PubMed 16142737Meijer JM, Meiners PM, Vissink A, Spijkervet FK, Abdulahad W, Kamminga N, Brouwer E, Kallenberg CG, Bootsma H. Effectiveness of rituximab treatment in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Apr;62(4):960-8. doi: 10.1002/art.27314.
PubMed 20131246
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00363350
- Acronym / sponsor ID
- METc2005.229
- Conditions
- Sjogren's Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.
Detailed description
Study design:
phase II trial
Study objective:
evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS
Number of participating centres:
1
Duration:
follow-up 48 weeks
Study medication:
2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20
Primary objective/endpoint:
stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)
Secondary objectives/endpoint:
Functional parameters Laboratory parameters Subjective parameters Histological/Molecular parameters
Number of subjects:
30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stimulated whole saliva secretion ≥ 0,15 ml/min
- Male or female > 18 years
- Primary SS according to the revised European - U.S. criteria(22)
- Positive autoantibodies (IgM-Rf > 10 and SS-A and/or SS-B)
- Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)
Key exclusion criteria (14 listed)
- The presence of any other connective tissue disease
- Preceding treatment with anti-TNF or other monoclonal antibodies
- Use of prednisone, hydroxychloroquine less than 1 month ago
- Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago
- Serum creatine > 2.8 mg/dl (250 micromol/l)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximab (anti-CD20)Also: Mabthera2 infusions of 1000 mg | Drug | – |
Primary outcome
stimulated whole salivary flow rate
Time frame: 48 weeks
4 secondary outcomes
Functional parameters
Time frame: 48 weeks
Laboratory parameters
Time frame: 48 weeks
Subjective parameters
Time frame: 48 weeks
Histological/Molecular parameters
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
- Background: PubMed 16142737Pijpe J, van Imhoff GW, Spijkervet FK, Roodenburg JL, Wolbink GJ, Mansour K, Vissink A, Kallenberg CG, Bootsma H. Rituximab treatment in patients with primary Sjogren's syndrome: an open-label phase II study. Arthritis Rheum. 2005 Sep;52(9):2740-50. doi: 10.1002/art.21260.
- Derived from this study: PubMed 20131246Meijer JM, Meiners PM, Vissink A, Spijkervet FK, Abdulahad W, Kamminga N, Brouwer E, Kallenberg CG, Bootsma H. Effectiveness of rituximab treatment in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Apr;62(4):960-8. doi: 10.1002/art.27314.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiska Meijer, MD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rituximab (anti-CD20) in people with Sjogren's Syndrome, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stimulated whole salivary flow rate (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363350, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2009.