Relapsing-remitting Multiple SclerosisPhase 1RESINCT02364986
Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis
A Phase 1 study testing Rebif® and Avonex in people with Relapsing-remitting Multiple Sclerosis, run by PD Dr. Marcus Müller at 2 sites in Germany.
Trial summary
There are two standard and a few second line treatments for RRMS. Since the disease cannot be cured by these existing treatments and all treatment options have significant limitations, there is the need to develop new treatment strategies to improve therapy of patients with RRMS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Rebif® and Avonex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2015to Jan 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participation in this study as proven by written informed consent
- Female or male patients with relapsing remitting MS according to McDon-ald-criteria (2010 revision) and decision for IFN-b treatment according to routine clinical criteria (not applying for healthy volunteers)
- Expanded Disability Status Scale (EDSS) between 0.0 and 6.0 (not applying for healthy volunteers)
- Naïve for IFN-b therapy (not applying for RRMS patients already under treatment)
- Age between 18 and 65 years
- Ability to follow study instructions and likely to attend and complete all required visits
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- Adequate organ function as described below:
- Adequate bone marrow reserve:
- White blood cell (WBC) count ≥ 3000/µl,
- granulocyte count > 1500/µl,
- platelets ≥ 100000/µl,
- haemoglobin ≥ 10 g/dl
- Adequate liver function
- bilirubin < 1.5 times above upper limit of normal range (ULN) (the higher concentrations are only allowed for patients with RRMS)
- alanine transaminase (ALT/SGPT) and aspartate transaminase (AST/SGOT) < 3 times ULN (the higher concentrations are only allowed for patients with RRMS)
- Adequate renal function: creatinine < 1.5 times ULN (the higher concentrations are only allowed for patients with RRMS)
- TSH within normal limits
- Adequate blood clotting:
- INR and PTT within normal limits
- Male and female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the trial (Pearl index <1; Oral hormonal contraception must be used in combination with a barrier device due to elevated risk of nausea. Use of an intrauterine device made of copper is not allowed for healthy volunteers due to MRI)
- Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
- MRI study: only healthy participants
Who cannot join
- Subjects not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Patients suffering from a form other than relapsing remitting Multiple Sclerosis (not applying for healthy volunteers)
- Patients with a MS relapse within 30 days before study inclusion
- EDSS >6.0 (not applying for healthy volunteers)
- Patients with known allergy or hypersensitivity to Interferon-beta or ingredients of the injection solution
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- Subjects with a physical or psychiatric condition/ a systemic disease which at the investigator's discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject's participation in this clinical trial or may prevent sufficient compliance
- Known or persistent abuse of medication, drugs or alcohol
- Prior malignancy (unless adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer). If prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence the subject can be enrolled at the discretion of the investigator
- Prior chemotherapy, systemic or local treatment with DNA-damaging and immune-modulating agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
- History of major depression, suicide attempt in the past, ongoing suicidal thoughts
- Cardiac insufficiency (NYHA III or IV), cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease, or significant hypertension at rest (BP > 180/110 mmHg)
- HIV, Hepatitis B or C infection or any relevant infectious disease which might interfere with the study procedures and results (at the discretion of the investigator)
- Women who are pregnant or breast-feeding
- Comedication with corticosteroids
- Female Patients with reproductive potential who do not accept to use contraception during the trial and 3 months thereafter
- Treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial or within the 30 days but at least 5 times the half life of the IMP before enrolment
- Very poor peripheral veins and pronounced fear of blood drawings
- Patients with history of epileptic seizures and / or under medical therapy with antiepileptic drugs
- MRI study: Metal implants (eg pacemaker, inner-ear prosthesis, nerve stimulator, implanted defibrillator, infusion pump, artificial joints), wearing of magnetic or metallic objects that cannot be removed from the body (such as body piercing, dental prosthesis, implanted electrodes, contraceptive coil, acupuncture needle), tattoos \& permanent makeup, claustrophobia, tinnitus, inability to lie on the back for an extended period of time, previous surgery on heart or head
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Neurology
Bonn, 53105
Marcus Müller, PD Dr., +49 (0) 228 287 15719, marcus_m.mueller@ukb.uni-bonn.de
- Recruiting
Phase I Unit
Bonn, 53105
Christoph Coch, Dr., +49 (0) 228 287 14018, christoph.coch@ukb.uni-bonn.de
About this study
There are two standard and a few second line treatments for RRMS. Since the disease cannot be cured by these existing treatments and all treatment options have significant limitations, there is the need to develop new treatment strategies to improve therapy of patients with RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients with MS. The RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but has advantages over therapy with recombinant IFN-b. Identification of suitable biomarkers to monitor treatment with RIG-I ligand and to guide the dose steps would help to increase the safety of the volunteers in the early clinical trials with RIG-I ligand.
The RESI study is designed to analyse immune readouts and potential biomarkers such as type I IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three times a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1 and 8), as they are routinely used in RRMS-therapy. The immune readouts are assessed on day 1, 3, 5 and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application by analysing blood samples. Since studies of the RIG-I ligand will start in healthy volunteers and will be continued in MS patients we need data from both populations since they could show significant differences in response to IFN-b. Thus, the RESI study includes healthy volunteers, RRMS-patients already under Rebif/Avonex treatment, and RRMS-patients who have to yet started a therapy with Rebif/Avonex.
Read the detailed description
Study subjects receive either Rebif or Avonex. Rebif is applied s.c. at a dose of 44 µg on day 1, day 3, day 5 and day 8, Avonex i.m. at a dose of 30µg on day 1 and 8. Blood samples are taken before application and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application to analyse the occuring immune response. The total duration of the trial for the individual subject are 9 days. An MRI ist performed before the first application of IMP and at the end of the study to investigate the correlation of Rebif/Avonex application and depression.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Rebif®, Avonex
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif®Drug
Also called Interferon beta 1a
Rebif® 44µg (day 1, 3, 5 and 8) s.c.
AvonexDrug
Also called Interferon beta 1a
Avonex 30µg (day 1 and 8) i.m.
| Study group | Role | What they receive |
|---|---|---|
| Rebif/Avonex | Experimental | Rebif® 44µg (day 1, 3, 5 and 8) s.c. Avonex 30µg (day 1 and 8) i.m. Receives: Drug: Rebif®; Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mRNA (IFN-b, CXCL10, IL-6, MxA and 5'-3'OAS) and protein expression (IFN-b, CXCL10, IL-6) in peripheral blood mononuclear cells/ serum
PBMCs and Serum are isolated from the blood before and at different time points after the application of Rebif/Avonex on day 1, 3, 5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs) to assess the changes in mRNA and protein expression related to Rebif/Avonex administration
Measured: before / after 1hr / 6 hrs / 12 hrs / 24 hrs
Secondary outcomes (11)
Change of mRNA and miRNA expression in peripheral blood mononuclear cells and serum in healthy volunteers as well as in patients with RRMS
PBMCs and Serum are isolated from the blood before and at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs) to assess the change in mRNA and miRNA expression determined by Chip Array related to Rebif/Avonex administration
Measured: before / after 1hr / 6 hrs / 12 hrs / 24 hrs
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Rebif/Avonex side effects and the occuring immune response (measured by protein- / gene- / miRNA-levels from PBMCs and Serum) are correlated at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs)
Measured: day 1 (+1 hr / 6hrs /12 hrs after 1. Rebif/Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Rebif/Avonex side effects and the occuring immune response (measured by protein- / gene- / miRNA-levels from PBMCs and Serum) are correlated at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs)
Measured: day 2 (24 hrs after 1.Rebif/Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Rebif/Avonex side effects and the occuring immune response (measured by protein- / gene- / miRNA-levels from PBMCs and Serum) are correlated at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs)
Measured: day 3 (48 hrs after 1.Rebif/Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Rebif/Avonex side effects and the occuring immune response (measured by protein- / gene- / miRNA-levels from PBMCs and Serum) are correlated at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs)
Measured: day 5 (48 hrs after 2.Rebif/ 96 hrs after 1. Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Rebif/Avonex side effects and the occuring immune response (measured by protein- / gene- / miRNA-levels from PBMCs and Serum) are correlated at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs)
Measured: day 8 (72 hrs after 3. Rebif application, +1 hr / 6hrs /12 hrs after 4. Rebif/ 2. Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Rebif/Avonex side effects and the occuring immune response (measured by protein- / gene- / miRNA-levels from PBMCs and Serum) are correlated at different time points after the application of Rebif/Avonex on day 1,3,5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs)
Measured: day 9 (24 hrs after 4. Rebif/ 2. Avonex application)
Psychometric testing: correlation between Rebif/Avonex administration and scores in depression and anxiety scales
Psychometric tests are performed before the first application of Rebif/Avonex and at the end of the study at day 9 (24 hrs after 4.Rebif application) and changes between the 2 time points are evaluated
Measured: before / day 9
MRI: Changes in regional cerebral blood flow at rest (arterial spin labeling) and their correlation with psychometric outcome variables and with transcriptome data
MRI is performed before the first application of Rebif/Avonex and at the end of the study at day 9 (24 hrs after 4.Rebif application) and changes between the 2 time points are evaluated
Measured: before / day 9
Changes in functional neuroimaging endophenotypes in the limbic system or prefrontal cortex that constitute possible markers of anxiety and depression and their correlation with psychometric outcome variables
Neuroimaging endophenotypes are assessed before the first application of Rebif/Avonex and at the end of the study at day 9 (24 hrs after 4.Rebif/ 2. Avonex application) and changes between the 2 time points are evaluated
Measured: before / day 9
Changes of IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA-expression pattern and functional immune tests between healthy volunteers, RRMS-patients naïve to IFN-b and RRMS-patients with established IFN-b treatment
PBMCs and Serum are isolated from the blood before and at different time points after the application of Rebif/Avonex on day 1, 3, 5 and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs) to assess the changes in protein- / gene- and miRNA expression related to Rebif administration
Measured: before / after 1hr / 6 hrs / 12 hrs / 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-remitting 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. Marcus Müller
- Sponsor type
- University, hospital or other
- Collaborators
- BfARM, Bonn, DZNE, Bonn
- Responsible party
- Sponsor-investigator, PD Dr. Marcus Müller, University Hospital, Bonn
- Investigators
- Marcus Müller, PD Dr., Principal investigator, Department of Neurology University Hospital Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364986
- Sponsor's protocol ID
- NEU-201201-RESI
- Acronym
- RESI
- Status last verified
- Jun 2016
- First submitted
- 10 Dec 2014
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Coenen M, Hinze AV, Mengel M, Fuhrmann C, Ludenbach B, Zimmermann J, Dykstra V, Fimmers R, Viviani R, Stingl J, Holdenrieder S, Muller M, Hartmann G, Coch C. Immune- and miRNA-response to recombinant interferon beta-1a: a biomarker evaluation study to guide the development of novel type I interferon- based therapies. BMC Pharmacol Toxicol. 2015 Sep 22;16:25. doi: 10.1186/s40360-015-0025-x.
PubMed 26392348
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02364986
- Acronym / sponsor ID
- RESI / NEU-201201-RESI
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PD Dr. Marcus MüllerUniversity, hospital or other
- Collaborators
- BfARM, Bonn, DZNE, Bonn
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 18 Feb 2015 (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.
There are two standard and a few second line treatments for RRMS. Since the disease cannot be cured by these existing treatments and all treatment options have significant limitations, there is the need to develop new treatment strategies to improve therapy of patients with RRMS. We developed a RIG-I ligand as a new therapeutic strategy for patients with MS. The RIG-I ligand functions partially via induction of Interferon beta (IFN-b), but has advantages over therapy with recombinant IFN-b. Identification of suitable biomarkers to monitor treatment with RIG-I ligand and to guide the dose steps would help to increase the safety of the volunteers in the early clinical trials with RIG-I ligand.
The RESI study is designed to analyse immune readouts and potential biomarkers such as type I IFN levels, type I IFN dependent immune activation and miRNA expression following Rebif or Avonex (Interferon beta 1a) application. Rebif is applied s.c. at a dose of 44 µg three times a week (on day 1,3,5 and 8), and Avonex i.m. at a dose of 30µg once a week (on day 1 and 8), as they are routinely used in RRMS-therapy. The immune readouts are assessed on day 1, 3, 5 and 8 immediately before application of Rebif/Avonex and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application by analysing blood samples. Since studies of the RIG-I ligand will start in healthy volunteers and will be continued in MS patients we need data from both populations since they could show significant differences in response to IFN-b. Thus, the RESI study includes healthy volunteers, RRMS-patients already under Rebif/Avonex treatment, and RRMS-patients who have to yet started a therapy with Rebif/Avonex.
Detailed description
Study subjects receive either Rebif or Avonex. Rebif is applied s.c. at a dose of 44 µg on day 1, day 3, day 5 and day 8, Avonex i.m. at a dose of 30µg on day 1 and 8. Blood samples are taken before application and on day 1 and 8 at 1 / 6 / 12 /24 hrs after Rebif/Avonex application to analyse the occuring immune response. The total duration of the trial for the individual subject are 9 days. An MRI ist performed before the first application of IMP and at the end of the study to investigate the correlation of Rebif/Avonex application and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebif/Avonex | Experimental | Drug: Rebif®, Drug: AvonexRebif® 44µg (day 1, 3, 5 and 8) s.c. Avonex 30µg (day 1 and 8) i.m. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Voluntary participation in this study as proven by written informed consent
- Female or male patients with relapsing remitting MS according to McDon-ald-criteria (2010 revision) and decision for IFN-b treatment according to routine clinical criteria (not applying for healthy volunteers)
- Expanded Disability Status Scale (EDSS) between 0.0 and 6.0 (not applying for healthy volunteers)
- Naïve for IFN-b therapy (not applying for RRMS patients already under treatment)
- Age between 18 and 65 years
Key exclusion criteria (20 listed)
- Subjects not able to give consent
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Patients suffering from a form other than relapsing remitting Multiple Sclerosis (not applying for healthy volunteers)
- Patients with a MS relapse within 30 days before study inclusion
- EDSS >6.0 (not applying for healthy volunteers)
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 |
|---|---|---|
| Rebif®Also: Interferon beta 1aRebif® 44µg (day 1, 3, 5 and 8) s.c. | Drug | Rebif/Avonex |
| AvonexAlso: Interferon beta 1aAvonex 30µg (day 1 and 8) i.m. | Drug | Rebif/Avonex |
Primary outcome
Change of mRNA (IFN-b, CXCL10, IL-6, MxA and 5'-3'OAS) and protein expression (IFN-b, CXCL10, IL-6) in peripheral blood mononuclear cells/ serum
Time frame: before / after 1hr / 6 hrs / 12 hrs / 24 hrs
PBMCs and Serum are isolated from the blood before and at different time points after the application of Rebif/Avonex on day 1, 3, 5, and 8 (before / after 1hr / 6 hrs / 12 hrs / 24 hrs) to assess the changes in mRNA and protein expression related to Rebif/Avonex administration
11 secondary outcomes
Change of mRNA and miRNA expression in peripheral blood mononuclear cells and serum in healthy volunteers as well as in patients with RRMS
Time frame: before / after 1hr / 6 hrs / 12 hrs / 24 hrs
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Time frame: day 1 (+1 hr / 6hrs /12 hrs after 1. Rebif/Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Time frame: day 2 (24 hrs after 1.Rebif/Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Time frame: day 3 (48 hrs after 1.Rebif/Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Time frame: day 5 (48 hrs after 2.Rebif/ 96 hrs after 1. Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Time frame: day 8 (72 hrs after 3. Rebif application, +1 hr / 6hrs /12 hrs after 4. Rebif/ 2. Avonex application)
Correlation of Rebif/Avonex side effects in patients with RRMS and healthy volunteers with changes in IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA expression pattern and functional immune tests
Time frame: day 9 (24 hrs after 4. Rebif/ 2. Avonex application)
Psychometric testing: correlation between Rebif/Avonex administration and scores in depression and anxiety scales
Time frame: before / day 9
MRI: Changes in regional cerebral blood flow at rest (arterial spin labeling) and their correlation with psychometric outcome variables and with transcriptome data
Time frame: before / day 9
Changes in functional neuroimaging endophenotypes in the limbic system or prefrontal cortex that constitute possible markers of anxiety and depression and their correlation with psychometric outcome variables
Time frame: before / day 9
Changes of IFN-b, CXCL10, MxA, 5'-3'OAS, IL-6 serum levels, gene- and miRNA-expression pattern and functional immune tests between healthy volunteers, RRMS-patients naïve to IFN-b and RRMS-patients with established IFN-b treatment
Time frame: before / after 1hr / 6 hrs / 12 hrs / 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Derived from this study: PubMed 26392348Coenen M, Hinze AV, Mengel M, Fuhrmann C, Ludenbach B, Zimmermann J, Dykstra V, Fimmers R, Viviani R, Stingl J, Holdenrieder S, Muller M, Hartmann G, Coch C. Immune- and miRNA-response to recombinant interferon beta-1a: a biomarker evaluation study to guide the development of novel type I interferon- based therapies. BMC Pharmacol Toxicol. 2015 Sep 22;16:25. doi: 10.1186/s40360-015-0025-x.
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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.
Marcus Müller, PD Dr. principal investigator
Department of Neurology University Hospital Bonn
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rebif® and Avonex in people with Relapsing-remitting Multiple Sclerosis, run by PD Dr. Marcus Müller at 2 sites 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 22 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verena Dykstra, Dr. (+49 (0) 228 287 16360, verena.dykstra@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mRNA (IFN-b, CXCL10, IL-6, MxA and 5'-3'OAS) and protein expression (IFN-b, CXCL10, IL-6) in peripheral blood mononuclear cells/ serum (time frame: before / after 1hr / 6 hrs / 12 hrs / 24 hrs). 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 NCT02364986, which also lists 1 linked publication.
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 3 Jun 2016.