AzTrials
AzTrials

Relapsing-Remitting Multiple SclerosisPhase 4NCT02142205

Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

A Phase 4 study testing BG00002 in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 11 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002, Tysabri®) in the study population (Russian participants with relapsing remitting multiple sclerosis). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Relapsing-Remitting Multiple Sclerosis
What is being tested?
BG00002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
11 sitesRussia
Study dates
May 2012to Dec 2013
Phase
Phase 4
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Must be natalizumab naïve.
  • Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al., 2011)
  • Must have had at least 1 relapse in the previous year:
  • Must be stable in disability for at least 30 days prior to enrollment to the study
  • Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study.
  • Must be considered by the Investigator to be free of signs and symptoms suggestive of Progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing.
  • Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and Glatiramer Acetate) while being treated with natalizumab during the study.

Who cannot join

  • Medical History:
  • Onset of a relapse within 50 days prior to first infusion.
  • Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment
  • History of, or available abnormal laboratory results indicative of, any significiant viral, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.
  • History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
  • Known history of human immunodeficiency virus infection or hematological malignancy
Show all 15Show fewer
  • History of organ transplantation (including anti-rejection therapy)
  • A clinically significant infectious illness (e.g. abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit.
  • Treatment History:
  • Treatment with any kind of immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, fingolimod, cladribine) within 6 months prior to Screening
  • Miscellaneous:
  • Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or unwilling to practice effective contraception (as defined by the Investigator) during the study
  • Women who are breastfeeding, pregnant, or planning to become pregnant while on study
  • Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Russia11 sites

  • Research Site

    Belgorod

  • Research Site

    Kaluga

  • Research Site

    Kazan'

  • Research Site

    Krasnodar

  • Research Site

    Kursk

  • Research Site

    Moscow

  • Research Site

    Nizhny Novgorod

  • Research Site

    Perm

  • Research Site

    Rostov-on-Don

  • Research Site

    Saint Petersburg

  • Research Site

    Smolensk

Other trials in Russia

About this study

Official title: A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).

The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002, Tysabri®) in the study population (Russian participants with relapsing remitting multiple sclerosis). The secondary objectives are to look at evaluation of severity of relapse, hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS), functional tests, quality of life self-assessment questionnaires including the short form health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29 (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.

Being tested
BG00002
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.

  • BG00002Biological

    Also called Tysabri®

    IV Infusion

Study groups in NCT02142205
Study groupRoleWhat they receive
BG00002 (natalizumab)Experimental300 mg IV infusion every 4 weeks
Receives: Biological: BG00002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs)

    Measured: Up to Week 52

Secondary outcomes (23)

  1. Annualized relapse rate (ARR)

    Measured: Up to Week 52

  2. Time course to first relapse

    Measured: Up to Week 52

  3. Severity of relapse as measured by the Number of relapses requiring hospitalization and the Number of relapses requiring steroid treatment

    Measured: Up to Week 52

  4. Number of participants that do not experience a relapse

    Measured: Up to Week 52

  5. Change in EDSS scores

    Measured: Up to Week 48

  6. Duration of time to progression as measured by EDSS score

    Measured: Up to Week 48

  7. Number of participants that do not experience a progression in EDSS score

    Measured: Up to Week 48

  8. Percentage of participants with improvement in EDSS scores

    Measured by at least 1.0 point for 3 months sustained for participants with EDSS greater than or equal to, 2 at baseline

    Measured: Up to Week 48

  9. Changes from baseline in nine hole peg test (9HPT)

    A brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The participant is seated at a table with a small, shallow container holding 9 pegs and a wood or plastic block containing 9 empty holes. On a start command when a stopwatch is started, the partipant picks up the 9 pegs one at a time as quickly as possible, puts them in the 9 holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded

    Measured: Up to Week 48

  10. Changes in Timed 25 foot walk from baseline

    A quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the Multiple Sclerosis Functional Composite (MSFC) to be administered at each visit. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately administered again by having the participant walk back the same distance. Assistive devices may be used

    Measured: Up to Week 48

  11. Changes in cognition as assessed by the Symbol digit modalities test (SDMT)

    A simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures. Examinees can give either written or spoken responses, making the test well suited for use with individuals who have motor disabilities or speech disorders. Because it involves only geometric figures and numbers, the SDMT is relatively free of cultural bias and can be administered to individuals who do not speak English.

    Measured: Up to Week 48

  12. Changes from baseline in visual function test (VFT)

    Measured: Up to Week 48

  13. Impact on participants quality of life using SF-36 and MSIS-29 self-assessment questionnaires

    Measured: Up to Week 48

  14. Percentage of participants that do not experience a relapse or progression in EDSS score

    Measured: Month 12

  15. Number of T1 gadolinium (Gd) enhancing lesions

    Measured: At Week 48

  16. Number of new T2 hyper intense lesions

    Compared to baseline

    Measured: At Week 48

  17. Number of newly enlarging T2 hyper intense lesions

    Compared to baseline

    Measured: At Week 48

  18. Number of new hypo intense T1 lesions (black holes)

    Measured: At Week 48

  19. Number of conversion of Gd lesions into black holes

    Measured: At Month 12

  20. Percentage of participants that do not experience a relapse as measured by an EDSS score that is not indicative of progression

    Measured: At Month 12

  21. Percentage of participants that do not develop new GD+ and new or newly enlarging T2 hyper intense lesions

    Measured: At Week 48

  22. Proportion of participants free of disease activity: no clinical & no MRI activity

    Measured: Up to Week 48

  23. Number of participates that are Anti JCV antibody positive at baseline

    Measured: At Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2014 (estimated)
  2. Study startMay 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02142205
Sponsor's protocol ID
RUS-TYS-11-10158
Status last verified
May 2014
First submitted
16 May 2014
Last updated
20 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BG00002 in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 11 sites in Russia.

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 7 inclusion and 15 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs) (time frame: Up to Week 52). 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 NCT02142205.

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 20 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in