Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population

NCT01804660

Multiple Sclerosis

COMPLETED

Predicting Disease Activity and Rebound Risk in MS Patients Treated With Sphingosine-1-phosphate Receptor Modulators (S1PRM)

NCT05828901

Multiple Sclerosis

RECRUITING

An Observational Biomarker Study in Multiple Sclerosis (MS) Patients

NCT05663853

Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive

COMPLETED

The MS-LINK™ Outcomes Study

NCT04735406

Multiple Sclerosis

COMPLETED

An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis

NCT01803867

Multiple Sclerosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis (MS) Relapsing-Remitting MS Primary Progressive MS Secondary Progressive MS Clinically Isolated Syndrome (CIS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

33 RRMS patients

No study treatments administered

No study treatments administered - blood draws only

Intervention Type OTHER

9 PPMS patients

No study treatments administered

No study treatments administered - blood draws only

Intervention Type OTHER

12 SPMS patients

No study treatments administered

No study treatments administered - blood draws only

Intervention Type OTHER

4 CIS patients

No study treatments administered

No study treatments administered - blood draws only

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No study treatments administered - blood draws only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signature of an informed consent;
* Male or female between 18 and 60 years of age;
* Patients with PPMS (Revised McDonald criteria 2010) or patients with SPMS or CIS or patients with RRMS (Revised McDonald criteria 2010) ideally without IFN beta therapy at the T0 visit for RRMS patient only.

Exclusion Criteria

* Positive serology for hepatitis B or C or HIV;
* Acute infection at inclusion;
* Severe psychiatric disorder;
* Autoimmune disease other than MS;
* Pregnancy or breastfeeding;
* Heavy smokers i.e. more than 10 cigarettes per day;
* History of alcohol or drug abuse in the last 3 years;
* Participation in a clinical trial (within the last 3 months).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No