Multiple Sclerosis, Relapsing-RemittingPhase 4NCT00112034
AVONEX® Combination Trial - "ACT"
A Phase 4 study testing Methotrexate and IV methylprednisolone in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Methotrexate and IV methylprednisolone
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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®.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MS Academic Coordinating Center
Cleveland, Ohio, 44195
About this study
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.
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Methotrexate, IV methylprednisolone
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, AVONEX, Combination, Methotrexate, IV Methylprednisolone, IVMP, ACT, MTX
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
IV methylprednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey A. Cohen, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112034
- Sponsor's protocol ID
- C-865
- Status last verified
- May 2008
- First submitted
- 27 May 2005
- Last updated
- 9 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00112034
- Acronym / sponsor ID
- C-865
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, AVONEX, Combination, Methotrexate, IV Methylprednisolone, IVMP, ACT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 30 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate | Drug | – |
| IV methylprednisolone | Drug | – |
Primary outcome
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
1 secondary outcome
Gadolinium enhancing lesion number on brain MRI, relapse rate, MS Functional Composite change, whole brain atrophy progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A. Cohen, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and IV methylprednisolone in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain MRI lesion activity measured by the combined number of T2-hyperintense lesions at Month 12 that are new or enlarged since Baseline. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.