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Relapsing-Remitting Multiple SclerosisPhase 4NCT00101959

Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) Subjects

A Phase 4 study testing Rebif in people with Relapsing-Remitting Multiple Sclerosis, run by EMD Serono.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Brief Summary: 800 RRMS Subjects currently treated with Avonex or Copaxone will be randomized to either continue on their current therapy or receive Rebif therapy. The subjects will be followed for 2 years. 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?
Rebif
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2004to not given
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

  • Written informed consent (and HIPAA authorization for USA subjects) before any study-related procedure, not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to future medical care
  • Age between 18 and 60 years (inclusive)
  • Male and female subjects with clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis based on Poser or McDonald criteria
  • Results of an MRI scan acquired within 2 years of screening, consistent with MS.
  • Duration of MS ≤ 7 years from onset of symptoms
  • Receiving consistent therapy with Avonex®, or Copaxone® for ≥ 2 years (Subjects that have converted from one therapy to another or who have used other disease-modifying therapies (DMTs) within two years of Screening will be excluded).
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  • Expanded Disability Status Score (EDSS) of 0 to ≤ 5.5, inclusive
  • Exhibiting low or medium level of concern based on number and severity of relapses within 12 months prior to screening (subjects who have reached a high level of concern at any time within the past 12 months will be excluded); *Low Level of Concern: a) 1 mild relapse (Mild severity - corticosteroids not required, minimal effect on Activities of Daily Living (ADL), only 1 Kurtzke Functional Systems (KFS) functional domain affected, no or mild motor/cerebellar involvement, no need for treatment or hospitalization and prompt recovery); *Medium Level of Concern: a) 2 mild relapses or 1 moderate relapse (Moderate severity - corticosteroids may be required, at most moderate effect on ADL, >1 KFS functional domain may be affected, moderate motor/cerebellar involvement, may require treatment but not hospitalization and incomplete recovery at 3 months but complete recovery by 6 months)
  • Clinical stability or improving neurological state during the eight weeks before Study Day 1
  • Willingness and ability to comply with the protocol for the duration of the study
  • If female, she must either:
  • be post-menopausal or surgically sterilized; or
  • use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
  • be neither pregnant nor breast-feeding.
  • confirmation that the subject is not pregnant must be established by a negative serum hCG pregnancy test within 30 days of Study Day 1 and a negative urine pregnancy test on Study Day 1. A pregnancy test is required for all females that are of childbearing potential.
  • The small minority of subjects for whom Rebif therapy is not reimbursed by their insurance carrier may be considered for the study if otherwise eligible, but will require prior approval from the sponsor for coverage of the cost of their Rebif therapy

Who cannot join

  • Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
  • Progressive forms of MS (Primary progressive, Secondary progressive)
  • Exhibiting a high level of concern based on number and severity of relapses at any time in the 12 months prior to screening; *High Level of Concern a) 3 mild, 2 moderate or 1 severe relapse (Severe Severity- Corticosteroids and hospitalization required, severe effect on ADL, >1 KFS functional domain may be affected, severe motor/cerebellar involvement, impact on ADL and incomplete recovery at 6 months)
  • Subjects who have been on DMTs other than Avonex® or Copaxone® in the two years prior to screening.
  • Subjects with history of intolerance to Interferon Beta
  • History of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the Rebif® formulation including mannitol
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  • History of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the Rebif® formulation including mannitol
  • Participation in any other studies involving investigational or marketed products, concomitantly or within 3 months prior to Study Day 1
  • Treatment with oral or systemic corticosteroids or ACTH within 4 weeks of Study Day 1 or ongoing chronic treatment with systemic corticosteroids.
  • Treatment with immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, Campath) within the 12 months prior to Study Day 1
  • Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
  • Prior use of cladribine or have received total lymphoid irradiation
  • Prior use of Antegren® (natalizumab)
  • Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 3 months prior to Study Day 1
  • Psychiatric disorder that is unstable or would preclude safe participation in the study
  • Cognitive impairment which impairs ability to understand or comply with the protocol procedures
  • Any laboratory value reaching Grade 2 toxicity or greater within 30 days of Study Day 1 based on Common Terminology Criteria for Adverse Events (CTACE) criteria
  • Specific systemic diseases, (including insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1, and Hepatitis B or C), or other uncontrolled major medical conditions (depression, seizure disorder) that would interfere with the participant's safety, compliance or evaluation
  • Unable and/or unlikely to follow the protocol for any reason
  • Alcohol and/or any other drug abuse
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  • Abnormal baseline clinical findings considered by the investigator to be indicative of conditions that might affect study results

About this study

Official title: An Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy

Brief Summary: 800 RRMS Subjects currently treated with Avonex or Copaxone will be randomized to either continue on their current therapy or receive Rebif therapy. The subjects will be followed for 2 years. The primary objective is to compare the time to worsening to a medium level of concern as defined by the Canadian Multiple Sclerosis Working Group (CMSWG) treatment optimization recommendations.

Being tested
Rebif
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.

  • RebifDrug

Timeline

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

  1. First posted19 Jan 2005 (estimated)
  2. Study startNov 2004

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
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101959
Sponsor's protocol ID
25277
Status last verified
Aug 2013
First submitted
18 Jan 2005
Last updated
6 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rebif in people with Relapsing-Remitting Multiple Sclerosis, run by EMD Serono.

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 16 inclusion and 22 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: withdrawn, as of the sponsor's last update on 6 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101959.

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 6 Aug 2013.

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