AVONEX® Combination Trial - "ACT"
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00112034
First received: May 27, 2005
Last updated: May 5, 2008
Last verified: May 2008
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Purpose
The purpose of this study is to determine the efficacy and safety of combination therapy with AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX monotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Methotrexate Drug: IV methylprednisolone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind |
| Official Title: | A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy. |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Methotrexate sodium
Interferon Beta-1a
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since Baseline
- effectiveness of AVONEX® and IVMP plus MTX in trying to reduce lesion activity on brain MRI
Secondary Outcome Measures:
- Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2003 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 to 55, inclusive
- Diagnosis of MS
- A relapsing-remitting course
- Expanded Disability Status Scale (EDSS) score 0.0-5.5 inclusive at Baseline
- Currently receiving AVONEX® therapy
- Treated with AVONEX® for at least 6 consecutive months prior
- Breakthrough disease (clinical relapse or gadolinium-enhancing MRI lesion) during the prior 12 months, at least 6 months after initiating AVONEX therapy.
Exclusion Criteria:
- History of cirrhosis, chronic hepatitis, or currently active hepatitis
- History of poorly-controlled hypertension, diabetes mellitus, or peptic ulcer disease
- History of aseptic bone necrosis, osteoporosis, or osteoporosis-related bone fracture
- History of steroid-induced psychosis.
- History of or abnormal laboratory results indicating significant illness
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity or intolerance to MTX, IVMP, or AVONEX®.
- History of allergy to albumin
- History of any episode of suicidal ideation or severe depression within 3 months of the Screening Visit.
- History of seizure within 3 months prior to the Screening Visit.
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- MS relapse with onset within 60 days prior to the Baseline Visit
- Any metallic or electronic material or device in the body, or condition that precludes the subject from undergoing MRI with gadolinium administration
- A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the Screening Visit
- Abnormal blood tests, performed at the Screening Visit, which exceed any of the limits defined by the study.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dennis Cunningham, Associate Director, Medical Affairs, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00112034 History of Changes |
| Other Study ID Numbers: | C-865 |
| Study First Received: | May 27, 2005 |
| Last Updated: | May 5, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
Multiple Sclerosis Relapsing-Remitting AVONEX Combination Methotrexate |
IV Methylprednisolone IVMP ACT MTX |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Methotrexate Interferon beta 1a Methylprednisolone Hemisuccinate Prednisolone Methylprednisolone acetate |
Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013