Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00168766 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : September 16, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsing-remitting Multiple Sclerosis | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 345 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
interferon-beta-1a in combination with methylprednisolone
|
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
Other Name: Avonex |
Placebo Comparator: 2
interferon-beta-1a in combination with placebo
|
Drug: Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.
Other Name: Avonex |
- To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS [ Time Frame: 4 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent
- Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
- Disability EDSS score of 4.0 or less at baseline
- Clinical activity as defined by at least one relapse in the last year
Exclusion Criteria:
- Relapse in the month prior to enrolment
- Treatment with immunosuppressive drugs for MS
- History of major depression
- Former severe reactions to corticosteroids
- Pregnant women
- Diabetes mellitus, and drug or alcohol dependency
- Known or suspected allergy to trial products

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168766
Belgium | |
CUB Hôpital Erasme | |
Bruxelles, Belgium | |
Denmark | |
Coordinating Research Site | |
Copenhagen, Denmark | |
Rigshospitalet | |
Skleroseklinikken, Denmark | |
Finland | |
Tampereen yliopistollinen sairaala - Neurologian klinikka | |
Tampere, Finland | |
Netherlands | |
Stichting MS Centrum | |
Nijemegen, Netherlands | |
Norway | |
Ullevål Universitetssykehus | |
Oslo, Norway | |
Sweden | |
Neurologkliniken | |
Stockholm, Sweden | |
Switzerland | |
Kantonspital | |
St. Gallen, Switzerland | |
United Kingdom | |
Queens Medical Centre - Division of Neurology | |
Nottingham, United Kingdom, Ng72uh |
Responsible Party: | Biogen Idec MD, Nordic Medical Director, Biogen Idec International |
ClinicalTrials.gov Identifier: | NCT00168766 |
Obsolete Identifiers: | NCT00492180 |
Other Study ID Numbers: |
NOR-03-01 Mecombin |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | September 16, 2013 |
Last Verified: | April 2011 |
Combination therapy for multiple sclerosis |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Interferons Interferon-beta Interferon beta-1a Methylprednisolone Antineoplastic Agents |
Antiviral Agents Anti-Infective Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents Immunologic Factors Adjuvants, Immunologic |