Systemic SclerodermaNCT01410903
Immunoadsorption in Patients With Severe Systemic Sclerosis
A study testing TheraSorb Ig in people with Systemic Scleroderma, run by GWT-TUD GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- TheraSorb Ig
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- 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
- systemic sclerosis according to the ACE-criteria
- severe pulmonary manifestation with reduced DLCO
- signed informed consent
Who cannot join
- inadequate peripheral venous access
- participation in another clinical trial
- heart failure
- pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis
The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.
- Conditions
- Systemic Scleroderma
- Being tested
- TheraSorb Ig
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSorb IgDevice
Also called Ig-TheraSorb, code 330-000-452
1,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months
| Study group | Role | What they receive |
|---|---|---|
| TheraSorb Ig | Experimental | Not described Receives: Device: TheraSorb Ig |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival under immunoadsorption
Measured: 6 months
Secondary outcomes (8)
survival under immunoadsorption
Measured: 12 months
Number of Serious Adverse Events
Measured: 12 months
change in "modified Rodnan Skin Score"
Measured: 12 months
change in Diffusing Capacity of the Lung for Carbon Monoxide
Measured: 12 months
change in Scleroderma Health Assenssment Questionnaire
Measured: 12 months
change of pulmonary arterial pressure
Measured: 12 months
reoccurrence of finger ulcers
Measured: 12 months
healing of finger ulcers
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionAug 2012
Why it stopped: inadequately recruitment rate, funding is not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Responsible party
- Sponsor
- Investigators
- Martin Aringer, Prof., Principal investigator, Universitätsklinikum Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410903
- Sponsor's protocol ID
- IAS - SSc 2010
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2011
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01410903
- Acronym / sponsor ID
- IAS - SSc 2010
- Conditions
- Systemic Scleroderma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequately recruitment rate, funding is not secured
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- Miltenyi Biomedicine GmbH
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Aug 2011 (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.
The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TheraSorb Ig | Experimental | Device: TheraSorb Ig |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- systemic sclerosis according to the ACE-criteria
- severe pulmonary manifestation with reduced DLCO
- signed informed consent
Key exclusion criteria (4 listed)
- inadequate peripheral venous access
- participation in another clinical trial
- heart failure
- pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit
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 |
|---|---|---|
| TheraSorb IgAlso: Ig-TheraSorb, code 330-000-4521,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months | Device | TheraSorb Ig |
Primary outcome
survival under immunoadsorption
Time frame: 6 months
8 secondary outcomes
survival under immunoadsorption
Time frame: 12 months
Number of Serious Adverse Events
Time frame: 12 months
change in "modified Rodnan Skin Score"
Time frame: 12 months
change in Diffusing Capacity of the Lung for Carbon Monoxide
Time frame: 12 months
change in Scleroderma Health Assenssment Questionnaire
Time frame: 12 months
change of pulmonary arterial pressure
Time frame: 12 months
reoccurrence of finger ulcers
Time frame: 12 months
healing of finger ulcers
Time frame: 12 months
Results and safety
The study was stopped early (reason given: inadequately recruitment rate, funding is not secured). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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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.
Martin Aringer, Prof. principal investigator
Universitätsklinikum Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSorb Ig in people with Systemic Scleroderma, run by GWT-TUD GmbH at 1 site in Germany.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Aug 2015. 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 Germany. 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.
Are results available for this study?
The study was stopped early (reason given: inadequately recruitment rate, funding is not secured). Results are not available in the source record.
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?
survival under immunoadsorption (time frame: 6 months). 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 19 Aug 2015.