A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®

Phase 1

• Conditions: Relapsing forms of multiple sclerosis; MedDRA version: 18.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-006262-40-GB
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-03
• Study Completion: 2016-03-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 419

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide
signed and dated Informed Consent Form (ICF) and authorization to use
protected health information (PHI) in accordance with national and local
subject privacy regulations.
2. Aged 18 to 58 years old, inclusive, at the time of informed consent.
3. Diagnosis of RRMS per the 2005 McDonald's criteria or onset of SPMS
per the Lublin and Reingold criteria.
4. For RRMS, subjects must have disease activity as defined by 2 or more
distinct occurrences of any of the following 3 events within 12 months of
enrollment: Clinical relapse Gd+ lesion on MRI (brain or spinal cord MRI)
New T2 lesion on MRI (brain or spinal cord MRI)
5. For SPMS, subjects must have disease activity as defined by 1 or more
distinct occurrences of any of the following 2 events within 12 months of
enrollment: Clinical relapse Gd+ lesion on MRI (brain or spinal cord MRI)
6. Baseline EDSS score of 2 to 6.
7. All male and female subjects of childbearing potential must practice
effective contraception during the study and be willing and able to
continue contraception for at least 6 months after their last dose of
study treatment (BIIB033 plus Avonex or placebo plus Avonex).
Are the trial subjects under 18? no
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 396
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of abnormal laboratory results that in the opinion of the
Investigator, are indicative of an significant cardiac, endocrine,
hematologic, immunologic, metabolic, urologic, pulmonary,
gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than
MS) and/or other major disease that would preclude administration of
BIIB033 and/or Avonex.
2. Any of the following abnormal blood tests at screening: hemoglobin =
9.0 g/dL platelets =100 X 109/L lymphocytes =1.0 X 109/L neutrophils
=1.5 X 109/L alanine aminotransferase/serum glutamate pyruvate
transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic
oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase
= 2 times the upper limit of normal (ULN) serum creatinine =ULN
3. Treatment with Botox for limb spasticity within 6 months before Day
1/Baseline.
4. Plans to undergo elective major procedures/surgeries at any time
during the study.
5. Simultaneous participation in another study protocol.
6. Treatment with any investigational MS drugs within 3 weeks or 5 t1/2
(whichever is longer) prior to Day 1/Baseline.
7. Treatment with high dose oral or IV steroids =30 days before Day
1/Baseline.
8. History of suicidal ideation or an episode of clinically severe
depression (as determined by the Investigator) within 3 months of
enrollment. Note: subjects receiving ongoing antidepressant therapy will
not be excluded from the study unless the medication has been
increased within the 6 months prior to enrollment.
9. RRMS subjects with any history of inadequate response to any
approved (in country of residence) interferon ß preparation (e.g.,
Avonex, Rebif, interferon ß-1b, or any generic interferon ß). (Inadequate
response definition: 2 or more distinct occurrences of clinical relapse
and/or Gd+ lesion on MRI and/or new or non-enhancing lesion on MRI
within any 12-month period while compliant with interferon ß.)
10. History of human immunodeficiency virus or other immunodeficient
conditions.
11. History of positive test result for hepatitis C virus Ab or Hepatitis B
virus (defined as positive for hepatitis B surface antigen or hepatitis B
core Ab).
12. History of drug or alcohol abuse (as defined by the Investigator)
within 2 years prior to randomization.
13. History of seizure disorder or unexplained blackouts OR history of a
seizure within 6 months prior to Baseline.
14. Female subjects who have a positive pregnancy test, are pregnant,
or currently breast feeding.
15. T25FW >30 seconds (any of the 2 tests at Screening).
16. History of malignancy; however subjects with a history or excised or
treated basal cell carcinoma or fewer than 3 squamous cell carcinomas
are eligible to partic

Study & Design

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