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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: Rebif® (clone 484-39) (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Bettina Stubinski, M.D., Study Director, Affiliation: Merck Serono SA - Geneva

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Testing Positive for Neutralising Antibody (NAb)

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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).

Locations and Contacts

Additional Information

Full FDA approved prescribing information can be found here

Starting date: May 2004
Last updated: January 26, 2014

Page last updated: August 23, 2015

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