A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study

Phase 1

• Conditions: MS with 2 or more relapses within the last 2 years; MedDRA version: 7.0Level: PTClassification code 10028245

• Registration Number: EUCTR2004-000337-12-HU
• Lead Sponsor: Serono International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-29
• Study Completion: 2006-01-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

To be eligible for inclusion into this study, each subject must fulfil the following criteria within 28 days prior to Study Day 0:
1.Have MS with two or more relapses in the past two years and is eligible for interferon therapy.
2.Be between 18 and 60 years of age, inclusive.
3.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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
4.Be willing and able to follow all study procedures for the duration of the study.
5.Have an EDSS score less than 6.0 (appendix C).
6.If female, she must
either
a) be post-menopausal or surgically sterilised;
or
b) use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study;
and
c) be neither pregnant nor breast-feeding.
Confirmation that the subject is not pregnant must be established by a negative SERUM hCG pregnancy test within 7 days of Study Day 0. A pregnancy test is not required if the subject is post-menopausal or surgically sterilised.

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Prior Interferon beta therapy (either beta-1b or beta-1a).
2.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.
3.Significant immunosuppressive therapy within the 6 months prior to enrolment.
4.Known history of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the formulation.
5.Epilepsy with a history of seizures not adequately controlled by treatment.
6.Have greater than Grade 1 toxicity for liver function tests (AST, ALT, GGT or total bilirubin) at the Screening visit (see Appendix D).
7.Have significant leukopenia (greater than Grade 1 toxicity for total white blood cell count or lymphopenia) at the Screening visit (see Appendix D).
8.Have had treatment with oral or systemic corticosteroids or ACTH within 1 month of the Screening visit or between the screening visit and study day 0.
9.Cytokine or anti-cytokine therapy within the 3 months prior to the Screening visit or between the screening visit and study day 0.
10.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.

11.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.
12.Prior use of cladribine or have received total lymphoid irradiation.
13.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, HIV, HTLV-1).
14.Other concurrent systemic disorders incompatible with the study (at the Investigator’s discretion).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified