Primary: To evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.Secondary: To describe long-term MS outcomes in subjects originally treated in Study 105MS301 who…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints: The incidence of adverse events (AEs), serious AEs (SAEs),
and discontinuations of study treatment due to an AE, as well as the incidence
of laboratory abnormalities.
Secondary outcome
Secondary endpoints: Secondary endpoints include MS relapse outcomes, MRI
outcomes, disability outcomes, Quality of Life (QoL), and other outcomes
assessed over the 2-year period of the study.
Background summary
The purpose of this Extension Study is to determine the long-term safety,
tolerability, and MS outcomes of BIIB017 in subjects completing Study 105MS301
(ADVANCE). Subjects will administer 125 mcg BIIB017 subcutaneously (SC) at 2
dose frequencies: every 2 weeks or every 4 weeks. In this extension study,
subjects will continue to administer BIIB017 at the same dose regimen they were
following during their participation in the second treatment year of Study
105MS301.
Once results from Study 105MS301 are available, the dose frequencies studied in
this extension study may be modified.
Study objective
Primary: To evaluate the long-term safety and tolerability of BIIB017 in
subjects originally treated in Study 105MS301 who continue BIIB017 treatment.
Secondary: To describe long-term MS outcomes in subjects originally treated in
Study 105MS301 who continue BIIB017 treatment.
Study design
Multicenter, parallel-group, dose-frequency blinded study
Intervention
Group 1: subjects will receive 125 mcg BIIB017 SC every 2 weeks for 96 weeks
Group 2: subjects will receive 125 mcg BIIB017 SC every 4 weeks for 96 weeks
Study burden and risks
Summary of procedures:
4x Physical Examination
7x Blood pressure and pulse
3x MRI
5x EDSS
4x Symbol Digit Modalities Test
4x Quality of Life Questionnaires
6x BDI-II questionnaire
Patients will keep a patient diary up to date.
No serious side effects of the study drug were reported in the healthy
volunteer studies (see Addendum III).
The side effects seen in clinical studies of BIIB017 in patients with MS are as
follows:
Very common (at least 1 in 10 people reported these symptoms if they had taken
BIIB017 for 1 year). This means that you may have at least a 10% chance of
having any of these symptoms if you take BIIB017.
* Injection site redness (erythema)
* Headache
* Flu-like illness
* Fever (pyrexia)
* Feeling weak (asthenia)
* Injection site itching
* Muscle pain (myalgia)
* Joint pain (arthralgia)
* Chills
* Back pain
* Injection site pain
Common (fewer than 1 in 10 people, but more than 1 in 100 people reported these
symptoms if they had taken BIIB017 for 1 year). This means that you may have
less than a 10% chance of having any of these symptoms if you take BIIB017.
* Increased body temperature (hyperthermia)
* Increased liver enzymes
* Vomiting
* Nausea
* Injection site warmth
* Injection site hematoma
* Injection site rash
* Pain
* Sleepiness (somnolence)
* Urinary tract infection
* Oral herpes
* Itching (pruritus)
* Injection site swelling (edema)
* Feeling unwell (malaise)
* Swollen lymph nodes (lymphadenopathy)
Serious side effects. The following serious side effects have been reported in
the ongoing studies of BIIB017 in patients with MS:
* Liver failure
* Increased level of liver tests (bilirubin, alanine aminotransferase, asparate
aminotransferase)
* Blood clot in the leg veins
* Malnutrition
* Pneumonia
* Partial paralysis
* Low platelet level (thrombocytopenia)
* Seizure
* Swelling of the skin
* Miscarriage
* Injection site redness
* Injection site pain
* Constipation
* Stomach swelling (abdominal distension)
* Blood infection (sepsis)
* Cancer of the lip and/or mouth
* Fever with decreased neutrophils (febrile neutropenia)
* Skin inflammation with death of the tissue (gangrenous cellulitis)
* Increased body temperature
* Infected bed sore (infected skin ulcer)
* Urinary tract infection
* Viral infection of the ear (herpes zoster oticus)
* Bipolar disorder
Other possible side effects:
-Liver injuries: Liver injury, including abnormal liver tests, hepatitis and
inflammation of the liver (autoimmune hepatitis) and rare cases of severe liver
failure have been reported with interferon beta (a drug that is similar to
BIIB017). Abnormal liver tests and liver injury have been observed with the use
of BIIB017.
-Depression and suicide
-Allergic reactions
-Injection site reactions
-Decreased blood cells
-Seizure
-Heart disease
Innovation House 70 Norden Road
Maidenhead Berkshire SL6 4AY
GB
Innovation House 70 Norden Road
Maidenhead Berkshire SL6 4AY
GB
Listed location countries
Age
Inclusion criteria
1. Subjects who participated in Study 105MS301, who completed the study treatment and visit schedule through Week 96.
Exclusion criteria
1. Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study
105MS301.
2. Subjects with any significant change in medical history, including laboratory tests, or a
current clinically significant condition that in the opinion of the Investigator would have
excluded the subject from participation in Study 105MS301. The Investigator must
re-review the subject*s medical fitness for participation and consider any factors that
would preclude treatment including:
* Presence of any clinically significant (as determined by the Investigator) cardiac,
endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude
participation in a clinical study.
* Presence of malignant disease, including solid tumors and hematologic malignancies
(with the exception of basal cell and squamous cell carcinomas of the skin that have
been completely excised and are considered cured).
* Clinically significant laboratory abnormalities (hematology and blood chemistry) on
the most recently available test of Study 105MS301, as determined by the Investigator.
Laboratory findings mandating discontinuation of study treatment as defined in
protocol 105MS301 are exclusionary.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024477-39-NL |
| ClinicalTrials.gov | NCT01332019 |
| CCMO | NL37071.068.11 |