Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)Phase 2NCT00936546
A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy
A Phase 2 study testing Rituximab in people with Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis), run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to 3 Jun 2015
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Fe) male >, = 18 years
- Fibrosing skin disorder, not fulfilling the ACR criteria for diffuse SSc
- Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated
- Debilitating disease defined by either one of the following:
- Restriction of mobility
- Disfiguration: eg: facial involvement
- Severe Internal Organ involvement
- Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.
Who cannot join
- FVC<, = 50%
- LVEF<, = 40% of predicted value,
- DLCO<, = 40% of predicted value
- Exclusion criteria as specifically described in the protocol for anti-CD-20:
- Lack of peripheral venous access.
- Pregnancy or breast feeding.
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- Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
- Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator's opinion, would preclude patient participation.
- Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
- Known active infection of any kind (excluding fungal infections of mail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline.
- History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline.
- History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening).
- History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
- History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins.
- Concurrent treatment with any biologic agent or DMARD other than MTX. Treatment must be discontinued 14 days prior to baseline , except for the following: azathioprine for ≥ 28 days; leflunomide for ≥ 8 weeks (or ≥ 14 days after 11 days of standard cholestyramine or activated charcoal washout); infliximab ≥ 8 weeks; adalimumab ≥ weeks.
- Previous treatment with > 1 biological agent.
- Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (which ever is the longer).
- Receipt of any vaccine within 28 days prior to baseline
- Intolerance or contraindications to i.v. glucocorticoids.
- Positive serum human chorionic gonadotropin (hCG) measured at screening or a positive pregnancy test prior to the first rituximab infusion.
- Positive tests for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.
- Hemoglobin < 8.0 g/dL.
- Concentrations of serum IgG and/or IgM below 5.0 and 0.40 mg/mL, respectively.
- Absolute neutrophil count (ANC) < 1.5 X 10³/µL.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially.
- Being tested
- Rituximab
- Medical subject headings
- Scleroderma, Localized, Eosinophilic Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Mabthera, Rituximab 1000 mg I.V.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.
Measured: Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.
Secondary outcomes (1)
Testing the efficacy of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.
Measured: Efficacy will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJun 2009
- Primary completion3 Jun 2015
- Study completion3 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip De Keyser, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936546
- Sponsor's protocol ID
- 2009/183
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2009
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00936546
- Acronym / sponsor ID
- 2009/183
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- 3 Jun 2015 (actual)
- Study completion
- 3 Jun 2015 (actual)
- First posted
- 10 Jul 2009 (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 will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (Fe) male >, = 18 years
- Fibrosing skin disorder, not fulfilling the ACR criteria for diffuse SSc
- Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated
- Debilitating disease defined by either one of the following:
- Restriction of mobility
Key exclusion criteria (24 listed)
- FVC<, = 50%
- LVEF<, = 40% of predicted value,
- DLCO<, = 40% of predicted value
- Exclusion criteria as specifically described in the protocol for anti-CD-20:
- Lack of peripheral venous access.
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 |
|---|---|---|
| RituximabMabthera, Rituximab 1000 mg I.V. | Drug | Rituximab |
Primary outcome
Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.
Time frame: Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.
1 secondary outcome
Testing the efficacy of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.
Time frame: Efficacy will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.
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 13 Jul 2021.
- website of the University Hospital GhentLink provided by the sponsor.
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.
Filip De Keyser, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis), run by University Hospital, Ghent at 1 site in Belgium.
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 8 inclusion and 24 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 13 Jul 2021. 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 Belgium. 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 phase mean?
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?
Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. (time frame: Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2021.