Multiple SclerosisNCT02671682
Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis
A study testing Immunoadsorption and Plasmapheresis in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Albert Christian Ludolph, Prof. at 1 site in Germany.
Trial summary
This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome
- What is being tested?
- Immunoadsorption and Plasmapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 26 Feb 2016to 25 Jan 2019
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
- informed consent
- age ≥ 12 years old
Who cannot join
- clinical or laboratory signs of infection
- intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081
About this study
Official title: Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome
This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Being tested
- Immunoadsorption, Plasmapheresis
- Keywords
- Immunoadsorption, Plasmapheresis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoadsorptionProcedure or surgery
PlasmapheresisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption | Experimental | Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume Receives: Procedure: Immunoadsorption |
| Plasmapheresis | Active comparator | Plasmapheresis on 5 consecutive days with 2l plasma exchange Receives: Procedure: Plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Functional Composite (MSFC)
Measured: 4 weeks
Secondary outcomes (11)
Expanded Disability Status Scale (EDSS)
Measured: 2 and 4 weeks
EuroQol (EQ5D-5L)
Measured: 2 and 4 weeks
Response Rate
defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value
Measured: 4 weeks
Vision
defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)
Measured: 4 weeks
Visually Evoked Potentials (VEP; P100 latency)
Measured: 4 weeks
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Measured: 4 weeks
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)
Measured: 4 weeks
Verbaler Lern- und Merkfähigkeitstest (VLMT) score
Measured: 4 weeks
MSFC
Measured: 2 weeks
Thickness of Ganglion Cell Layer (GCL) in OCT
Measured: 4 weeks
Symbol Digit Modalities Test (SDMT) score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start26 Feb 2016
- Primary completion3 Jan 2019
- Study completion25 Jan 2019
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 Multiple SclerosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Christian Ludolph, Prof.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albert Christian Ludolph, Prof., University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671682
- Sponsor's protocol ID
- IAPEMS
- Status last verified
- Sep 2019
- First submitted
- 22 Jan 2016
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vardakas I, Dorst J, Huss A, Mayer B, Fangerau T, Taranu D, Tumani H, Senel M. Serum neurofilament light chain and glial fibrillary acidic protein for predicting response to apheresis in steroid-refractory multiple sclerosis relapses. Eur J Neurol. 2024 Aug;31(8):e16323. doi: 10.1111/ene.16323. Epub 2024 May 3.
PubMed 38700322Dorst J, Fangerau T, Taranu D, Eichele P, Dreyhaupt J, Michels S, Schuster J, Ludolph AC, Senel M, Tumani H. Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial. EClinicalMedicine. 2019 Nov 14;16:98-106. doi: 10.1016/j.eclinm.2019.10.017. eCollection 2019 Nov.
PubMed 31832624
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome
- ClinicalTrials.gov ID
- NCT02671682
- Acronym / sponsor ID
- IAPEMS
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- Immunoadsorption, Plasmapheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Albert Christian Ludolph, Prof.University, hospital or other
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 2 Feb 2016 (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 observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption | Experimental | Procedure: ImmunoadsorptionImmunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume |
| Plasmapheresis | Active comparator | Procedure: PlasmapheresisPlasmapheresis on 5 consecutive days with 2l plasma exchange |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
- informed consent
- age ≥ 12 years old
Key exclusion criteria (2 listed)
- clinical or laboratory signs of infection
- intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment
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 |
|---|---|---|
| Immunoadsorption | Procedure or surgery | Immunoadsorption |
| Plasmapheresis | Procedure or surgery | Plasmapheresis |
Primary outcome
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 4 weeks
11 secondary outcomes
Expanded Disability Status Scale (EDSS)
Time frame: 2 and 4 weeks
EuroQol (EQ5D-5L)
Time frame: 2 and 4 weeks
Response Rate
Time frame: 4 weeks
Vision
Time frame: 4 weeks
Visually Evoked Potentials (VEP; P100 latency)
Time frame: 4 weeks
Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
Time frame: 4 weeks
Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)
Time frame: 4 weeks
Verbaler Lern- und Merkfähigkeitstest (VLMT) score
Time frame: 4 weeks
MSFC
Time frame: 2 weeks
Thickness of Ganglion Cell Layer (GCL) in OCT
Time frame: 4 weeks
Symbol Digit Modalities Test (SDMT) score
Time frame: 4 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 11 Sep 2019.
- Derived from this study: PubMed 38700322Vardakas I, Dorst J, Huss A, Mayer B, Fangerau T, Taranu D, Tumani H, Senel M. Serum neurofilament light chain and glial fibrillary acidic protein for predicting response to apheresis in steroid-refractory multiple sclerosis relapses. Eur J Neurol. 2024 Aug;31(8):e16323. doi: 10.1111/ene.16323. Epub 2024 May 3.
- Derived from this study: PubMed 31832624Dorst J, Fangerau T, Taranu D, Eichele P, Dreyhaupt J, Michels S, Schuster J, Ludolph AC, Senel M, Tumani H. Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial. EClinicalMedicine. 2019 Nov 14;16:98-106. doi: 10.1016/j.eclinm.2019.10.017. eCollection 2019 Nov.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunoadsorption and Plasmapheresis in people with Multiple Sclerosis and Clinically Isolated Syndrome, run by Albert Christian Ludolph, Prof. 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 2 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 11 Sep 2019. 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 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?
Multiple Sclerosis Functional Composite (MSFC) (time frame: 4 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 NCT02671682, 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 11 Sep 2019.