Multiple SclerosisPhase 2/3NCT00223301
Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
A Phase 2/3 study testing Mycophenolate Mofetil (cellcept) in people with Multiple Sclerosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
1. To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. 2. To document changes in exacerbation frequency, 3. To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis), 4. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mycophenolate Mofetil (cellcept)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Mar 2007
- Phase
- Phase 2/3
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 21-45 inclusive
- Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref .
- At least one exacerbation in the preceding two years
- Written informed consent.
Who cannot join
- Primary progressive, secondary progressive or progressive relapsing MS.
- Corticosteroids during the 60 days prior to study entry.
- Treatment with plasma exchange within 90 days of preenrollment.
- No prior exposure to total lymphoid irradiation.
- No prior use of interferons, monoclonal antibodies, glatiramer acetate, methotrexate or other immunomodulatory drugs
- A clinical relapse within 60 days prior to enrollment.
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- Pregnant/breastfeeding.
- Patients with major medical illnesses.
- Cognitive impairment interfering with ability to comply with the protocol.
- Patients who need to remain on any contraindicated medication.
- Diabetic
- Inability to undergo MRI scan
- On intravenous immunoglobulin protocol
- HIV+ or RPR+
- Females of childbearing age who have not undergone a sterilization procedure must be willing to practice effective birth control.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8806
About this study
Official title: A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis
- To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS.
- To document changes in exacerbation frequency,
- To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis),
- To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI),
- To document changes in quality of life measures,
- To assess fatigue with the validated fatigue assessment inventory,
- Neuroimmunological studies:At baseline, 6 and 12 months after treatment
Read the detailed description
Design: Uni-center, double-blind, randomized, placebo-controlled study of Avonex + placebo vs Avonex + Cellcept
Rationale: A number of immunopathogenic mechanisms have been hypothesized to figure prominently in the processes that culminate in the characteristic plaque lesion. These include the role of cytokines, chemokines, excitatory amino acids, free radicals, superoxides, and nitric oxide synthetase products. Recognizing that the disease process in MS involves a cascade of biological events, sets the stage for strategically targeting specific immunopathogenetic steps through rational combination therapy regimens. We now propose a combination clinical trial utilizing Avonex and mycophenolate mofetil (MMF), a novel agent with a broad spectrum of anti- inflammatory mechanisms.
- Study population: MS patients who have been diagnosed with clinically definite, laboratory supported definite, or monosymptomatic MS meeting CHAMPS criteria ref , of either sex, who are between the ages of 21 and 50 inclusive.
- Treatment Groups: 12 patients in each group, ALL patients on Intramuscular Avonex. Cellcept/Placebo will be started at 250mg bid for one week and then escalated by 250mg bid until a target dose of 1000mg bid is achieved and Avonex 30 mcg IM q week
Patients also see an examining physician every three months, have brain MRI scans done every other month and donate WBCs through a procedure called leukapheresis (done every six months).
- Efficacy Parameters/Evaluations: EDSS, PSAT, MSFC and MRI, relapse rate and safety measures
- Safety Parameters/Evaluations: Safety will be assessed by virtue of changes in T2/FLAIR lesions (number and volume) and in gadolinium enhancements (measured at 6 and 12 months after treatment initiation) compared to baseline measurements derived from one pretreatment run- in scan. In addition, a variety of clinical assessments will be performed for the period of 12 months of treatment. We will enroll 12 patients in each group (24 total)
- Conditions
- Multiple Sclerosis
- Being tested
- Mycophenolate Mofetil (cellcept)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil (cellcept)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less
Secondary outcomes (8)
To document changes in exacerbation frequency
To document the incidence of mild, moderate, and severe exacerbations in the treated groups.
To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.
To document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).
To assess fatigue with the validated fatigue assessment inventory
Neuroimmunological studies:At baseline, 6 and 12 months after treatment.
Pharmacodynamics.
Genetic Studies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Biogen
- Responsible party
- Principal investigator, Elliot Frohman, University of Texas Southwestern Medical Center
- Investigators
- Elliot Frohman, MD/PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223301
- Sponsor's protocol ID
- 1103-716
- Status last verified
- Apr 2013
- First submitted
- 19 Sep 2005
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-Year Prospective, Randomized, Placebo-Controlled, Double-Blind, Phase II/III Safety Trial of Combination Therapy With IFN Beta-1a (Avonex) and Mycophenolate Mofetil (Cellcept) in Early Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00223301
- Acronym / sponsor ID
- 1103-716
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Biogen
- Study start
- Jul 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 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.
- To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS.
- To document changes in exacerbation frequency,
- To document the incidence of mild, moderate, and severe exacerbations in the treated groups (categorical analysis),
- To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI),
- To document changes in quality of life measures,
- To assess fatigue with the validated fatigue assessment inventory,
- Neuroimmunological studies:At baseline, 6 and 12 months after treatment
Detailed description
Design: Uni-center, double-blind, randomized, placebo-controlled study of Avonex + placebo vs Avonex + Cellcept
Rationale: A number of immunopathogenic mechanisms have been hypothesized to figure prominently in the processes that culminate in the characteristic plaque lesion. These include the role of cytokines, chemokines, excitatory amino acids, free radicals, superoxides, and nitric oxide synthetase products. Recognizing that the disease process in MS involves a cascade of biological events, sets the stage for strategically targeting specific immunopathogenetic steps through rational combination therapy regimens. We now propose a combination clinical trial utilizing Avonex and mycophenolate mofetil (MMF), a novel agent with a broad spectrum of anti- inflammatory mechanisms.
- Study population: MS patients who have been diagnosed with clinically definite, laboratory supported definite, or monosymptomatic MS meeting CHAMPS criteria ref , of either sex, who are between the ages of 21 and 50 inclusive.
- Treatment Groups: 12 patients in each group, ALL patients on Intramuscular Avonex. Cellcept/Placebo will be started at 250mg bid for one week and then escalated by 250mg bid until a target dose of 1000mg bid is achieved and Avonex 30 mcg IM q week
Patients also see an examining physician every three months, have brain MRI scans done every other month and donate WBCs through a procedure called leukapheresis (done every six months).
- Efficacy Parameters/Evaluations: EDSS, PSAT, MSFC and MRI, relapse rate and safety measures
- Safety Parameters/Evaluations: Safety will be assessed by virtue of changes in T2/FLAIR lesions (number and volume) and in gadolinium enhancements (measured at 6 and 12 months after treatment initiation) compared to baseline measurements derived from one pretreatment run- in scan. In addition, a variety of clinical assessments will be performed for the period of 12 months of treatment. We will enroll 12 patients in each group (24 total)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 21-45 inclusive
- Clinically definite, laboratory supported definite relapsing MS of less than or equal to two years in duration or monosymptomatic MS meeting CHAMPS criteria ref .
- At least one exacerbation in the preceding two years
- Written informed consent.
Key exclusion criteria (15 listed)
- Primary progressive, secondary progressive or progressive relapsing MS.
- Corticosteroids during the 60 days prior to study entry.
- Treatment with plasma exchange within 90 days of preenrollment.
- No prior exposure to total lymphoid irradiation.
- No prior use of interferons, monoclonal antibodies, glatiramer acetate, methotrexate or other immunomodulatory drugs
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 |
|---|---|---|
| Mycophenolate Mofetil (cellcept) | Drug | – |
Primary outcome
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less
8 secondary outcomes
To document changes in exacerbation frequency
To document the incidence of mild, moderate, and severe exacerbations in the treated groups.
To document changes in the level of sustained disability as measured by the expanded disability status score (EDSS) and ambulation index (AI) as assessed by the Kaplan-Meier methodology.
To document changes in quality of life measures (MSQOL-54, SF-36, and Beck's Depression Index).
To assess fatigue with the validated fatigue assessment inventory
Neuroimmunological studies:At baseline, 6 and 12 months after treatment.
Pharmacodynamics.
Genetic Studies.
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 Apr 2013.
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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.
Elliot Frohman, MD/PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mycophenolate Mofetil (cellcept) in people with Multiple Sclerosis, run by University of Texas Southwestern Medical 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 4 inclusion and 15 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 Apr 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS. Early MS for this study is defined at a definite diagnosis of less. 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 22 Apr 2013.