Relapsing-remitting Multiple SclerosisNCT00232193
Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS
An observational study of Relapsing-remitting Multiple Sclerosis and Clinically Isolated Syndrome, run by Providence Multiple Sclerosis Center at 1 site in United States.
Trial summary
The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain lesions over the first 24 months of Avonex… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis, Clinically Isolated Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Aug 2010
- Phase
- Observational
- 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
Study population: Treatment-naive MS patients with either RRMS or CIS, of either gender, between 18 to 55 years of age inclusive, with baseline EDSS of 0 to 3.5, fulfilling McDonald criteria for MS or CHAMPS criteria for CIS, were randomly assigned to one of two treatment groups.
Who may be able to join
- male and female patients between the ages of 18-55 years inclusive
- have provided informed consent to be screened for the study
- have been diagnoses as having MS
- meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
- have an EDSS score of 0.0-3.5
- have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
- must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
- subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments
Who cannot join
- type I of type II diabetes
- uncontrolled hypertension (systolic >160 or diastolic >100 despite medication therapy)
- history of suicidal ideation
- history of psychosis
- history of alcoholism or other substance abuse
- clinically significant coronary artery disease
Show all 20Show fewer
- history of hepatic failure and chronic renal failure
- history of cancer other than basal or squamous cell carcinoma of the skin
- pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
- nursing mothers
- history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
- history of peptic ulcer disease
- history of intolerance to corticosteroids or allergy to albumin
- history of osteoporosis
- history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
- abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
- the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
- prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
- unwillingness or inability to comply with all the requirements of the protocol
- known diagnosis of osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis
The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or mono-symptomatic multiple sclerosis.
Read the detailed description
Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and progression of neurological and cognitive disability with the use of Avonex, as well as reduction in brain atrophy and new MS lesions on MRI were observed. Despite this, Avonex does not abolish disease activity, therefore, there is frequent need for adjunctive therapy, such as short courses of corticosteroids.
This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine: a)safety and tolerability b)if this therapy will reduce the progression of functional impairment, and c)if this therapy will reduce the progression of whole brain atrophy over a 13 month observation period.
- Keywords
- Multiple Sclerosis, Interferon Beta 1-a, Pulsed steroids
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IFNβ+DS group | IFNβ+DS group received lyophilized Avonex 30mcg IM weekly plus dexamethasone 160 mg IV every 4 weeks for 52 weeks and was treated with Avonex 30mcg IM weekly from week 53 to 104 | |
| IFNβ group | IFNβ group received lyophilized Avonex 30mcg IM weekly for 104 weeks |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startDec 2003
- Primary completionDec 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Multiple Sclerosis Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Stanley L. Cohan, M.D., Ph.D., Principal investigator, Providence Multiple Sclerosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232193
- Sponsor's protocol ID
- 011-03-AVX
- Status last verified
- Jul 2011
- First submitted
- 30 Sep 2005
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Adjunctive Treatment at Initiation of Avonex Therapy for Patients With Mono-Symptomatic or Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00232193
- Acronym / sponsor ID
- 011-03-AVX
- Keywords
- Multiple Sclerosis, Interferon Beta 1-a, Pulsed steroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Providence Multiple Sclerosis CenterUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Dec 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Oct 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 the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or mono-symptomatic multiple sclerosis.
Detailed description
Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and progression of neurological and cognitive disability with the use of Avonex, as well as reduction in brain atrophy and new MS lesions on MRI were observed. Despite this, Avonex does not abolish disease activity, therefore, there is frequent need for adjunctive therapy, such as short courses of corticosteroids.
This study will research the value of adding monthly pulsed corticosteroids as adjunctive therapy during the first year of Avonex use to determine: a)safety and tolerability b)if this therapy will reduce the progression of functional impairment, and c)if this therapy will reduce the progression of whole brain atrophy over a 13 month observation period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFNβ+DS group | – | –IFNβ+DS group received lyophilized Avonex 30mcg IM weekly plus dexamethasone 160 mg IV every 4 weeks for 52 weeks and was treated with Avonex 30mcg IM weekly from week 53 to 104 |
| IFNβ group | – | –IFNβ group received lyophilized Avonex 30mcg IM weekly for 104 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Treatment-naive MS patients with either RRMS or CIS, of either gender, between 18 to 55 years of age inclusive, with baseline EDSS of 0 to 3.5, fulfilling McDonald criteria for MS or CHAMPS criteria for CIS, were randomly assigned to one of two treatment groups.
Key inclusion criteria (8 listed)
- male and female patients between the ages of 18-55 years inclusive
- have provided informed consent to be screened for the study
- have been diagnoses as having MS
- meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
- have an EDSS score of 0.0-3.5
Key exclusion criteria (20 listed)
- type I of type II diabetes
- uncontrolled hypertension (systolic >160 or diastolic >100 despite medication therapy)
- history of suicidal ideation
- history of psychosis
- history of alcoholism or other substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 22 Jul 2011.
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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.
Stanley L. Cohan, M.D., Ph.D. principal investigator
Providence Multiple Sclerosis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing-remitting Multiple Sclerosis and Clinically Isolated Syndrome, run by Providence Multiple Sclerosis Center 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 8 inclusion and 20 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 22 Jul 2011. 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.
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.
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 22 Jul 2011.