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Immune- and miRNA-response to Recombinant Interferon Beta in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis

NCT02364986 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-06-03

No results posted yet for this study

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. 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.

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

DRUG

Rebif®

Rebif® 44µg (day 1, 3, 5 and 8) s.c.

DRUG

Avonex

Avonex 30µg (day 1 and 8) i.m.

Sponsors & Collaborators

  • BfARM, Bonn

    collaborator UNKNOWN

  • DZNE, Bonn

    collaborator UNKNOWN

  • PD Dr. Marcus Müller

    lead OTHER

Principal Investigators

  • Marcus Müller, PD Dr. · Department of Neurology University Hospital Bonn

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364986 on ClinicalTrials.gov