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Rebif New Formulation (RNF) Quality of Life (QOL) Study (RebiQoL)

Primary Purpose

Relapsing Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Rebif New Formulation Non Titrated

Rebif New Formulation Titrated

About this trial

This is an interventional supportive care trial for Relapsing Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
Subject currently using Rebiject II and 29 gauge needle
Subject is between 18 and 60 years old inclusive
Subject is able to read and understand English
Subject is willing to follow study procedures
Subject has given written informed consent and signed HIPAA
Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)

Exclusion Criteria:

Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
Subjects who have previously been on Rebif New Formulation (RNF).
Subject with progressive forms of Multiple Sclerosis (MS).
Subject with history of any chronic pain syndrome.
Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
Subject has complete transverse myelitis or bilateral optic neuritis.
Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
Subject suffers from other current autoimmune disease.
Subject suffers from 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
Subject is pregnant or attempting to conceive
Visual or physical impairment that precludes completion of diaries and questionnaires.

Sites / Locations

EMD Serono, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Rebif New Formulation - Non Titrated

Rebif New Formulation - Titrated

Outcomes

Primary Outcome Measures

Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)

The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 - score at baseline) / score at baseline.

Secondary Outcome Measures

Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).

Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 - score at baseline.

Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12

The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).

Tolerability in Pain Using Visual Analog Scale (VAS)

The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.

Tolerability - Redness at Injection Site

Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.

Full Information

NCT ID

NCT00472797

First Posted

May 10, 2007

Last Updated

August 2, 2013

Sponsor

EMD Serono

1. Study Identification

Unique Protocol Identification Number

NCT00472797

Brief Title

Rebif New Formulation (RNF) Quality of Life (QOL) Study

Acronym

RebiQoL

Official Title

A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

EMD Serono

4. Oversight

5. Study Description

Brief Summary

To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

232 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Rebif New Formulation - Non Titrated

Arm Title

Arm Type

Active Comparator

Arm Description

Rebif New Formulation - Titrated

Intervention Type

Drug

Intervention Name(s)

Rebif New Formulation Non Titrated

Intervention Description

human interferon beta 1a - Rebif New Formulation

Intervention Type

Drug

Intervention Name(s)

Rebif New Formulation Titrated

Intervention Description

Human interferon beta 1a Rebif New Formulation

Primary Outcome Measure Information:

Title

Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)

Description

Time Frame

% change from Baseline to Week 12

Secondary Outcome Measure Information:

Title

Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

Description

The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).

Time Frame

Baseline and Week 12

Title

Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

Description

Time Frame

Baseline to Week 12

Title

Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12

Description

Time Frame

Baseline to Week 12

Title

Tolerability in Pain Using Visual Analog Scale (VAS)

Description

The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.

Time Frame

Baseline to Week 12

Title

Tolerability - Redness at Injection Site

Description

Time Frame

Baseline to Week 12 (LOCF)

Other Pre-specified Outcome Measures:

Title

SF-36 Physical and Mental Component Scores

Description

Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.

Time Frame

Change from Baseline to Each Visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment Subject currently using Rebiject II and 29 gauge needle Subject is between 18 and 60 years old inclusive Subject is able to read and understand English Subject is willing to follow study procedures Subject has given written informed consent and signed HIPAA Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study) Exclusion Criteria: Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol. Subjects who have previously been on Rebif New Formulation (RNF). Subject with progressive forms of Multiple Sclerosis (MS). Subject with history of any chronic pain syndrome. Subject has any other disease apart from MS that could better explain the subjects signs and symptoms. Subject has complete transverse myelitis or bilateral optic neuritis. Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment). Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal. Subject suffers from other current autoimmune disease. Subject suffers from 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 Subject is pregnant or attempting to conceive Visual or physical impairment that precludes completion of diaries and questionnaires.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Dangond, MD

Organizational Affiliation

EMD Serono

Official's Role

Study Director

Facility Information:

Facility Name

EMD Serono, Inc.

City

Rockland

State/Province

Massachusetts

ZIP/Postal Code

02370

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mslifelines.com

Description

Full FDA approved prescribing information can be found here

Learn more about this trial

Rebif New Formulation (RNF) Quality of Life (QOL) Study

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