Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple Sclerosis

January 26, 2014 updated by: Merck KGaA, Darmstadt, Germany

Multicentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple Sclerosis

The objectives of the study are:

- comparison of the incidence and time course of the development of neutralizing antibodies (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif®

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have multiple sclerosis (MS) with two or more relapses in the past two years and is eligible for interferon therapy.
  • Be between 18 and 60 years of age, inclusive.
  • Have given written informed consent, prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
  • Be willing and able to follow all study procedures for the duration of the study.
  • Have an Expanded Disability Scale Score (EDSS) less than 6.0

  • If female, she must either

    1. be post menopausal or surgically sterilised; or
    2. use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
    3. be neither pregnant nor breast feeding. Confirmation that the subject is not pregnant must be established by a negative SERUM human Chorionic Gonadotrophin (hCG) pregnancy test between 28 to 7 days before Study Day 0.Urine pregnancy test must be done if serum hCG pregnancy test was performed more than 7 days before Study Day 0. A pregnancy test is not required if the subject is post menopausal or surgically sterilised.

Exclusion Criteria:

  • Prior Interferon beta therapy (either beta-1b or beta-1a).
  • Major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol.
  • Significant immunosuppressive therapy within the 6 months prior to enrolment.
  • Known history of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the formulation.
  • Epilepsy with a history of seizures not adequately controlled by treatment.
  • Have greater than Grade 1 toxicity for liver function tests (Aspartate Transaminase (AST), Alanine Transaminase (ALT), Gamma-Glutamyl Transferase (GGT) or total bilirubin) at the Screening visit
  • Have significant leukopenia (greater than Grade 1 toxicity for total white blood cell count or lymphopenia) at the Screening visit
  • Have had treatment with oral or systemic corticosteroids or Adrenocorticotrophic hormone (ACTH) within 1 month of the Screening visit or between the screening visit and study day 0.
  • Cytokine or anti-cytokine therapy within the 3 months prior to the Screening visit or between the screening visit and study day 0.
  • Use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide) within the 6 months prior to the Screening visit or between the screening visit and study day 0.
  • Have taken intravenous immunoglobulin or glatiramer acetate or mitoxantrone or any investigational drug or experimental procedure within the 3 months prior to the Screening visit or between the screening visit and study day 0.
  • Prior use of cladribine or have received total lymphoid irradiation.
  • Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. poorly controlled insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus (HIV), human T-lymphotrophic virus 1 (HTLV-1)).

Other concurrent systemic disorders incompatible with the study (at the Investigator's discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rebif® (clone 484-39)
Rebif® 44 mcg, three times per week (tiw), subcutaneously (s.c.) During the first 4 weeks of the study, subjects underwent a dose titration regimen of 40% of Rebif® 22 mcg or 20% of Rebif® 44 mcg tiw (8.8 mcg per injection) in the first and second week followed by 100% of Rebif® 22 mcg or 50% of Rebif® 44 mcg (22 mcg per injection) in the third and fourth week. After 4 weeks, subjects received 44 mcg injected s.c. tiw.
Biological: Rebif® (clone 484-39)
s.c. administered Rebif®
Other Names:
  • Recombinant-human interferon beta-1a
  • r-hIFN Beta-1a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Testing Positive for Neutralising Antibody (NAb)
Time Frame: 48 Weeks
Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Bettina Stubinski, M.D., Merck Serono SA - Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria

August 21, 2006

First Posted (Estimate)

August 23, 2006

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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