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Avonex Medical Research Studies

Up-to-date List of Avonex Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Avonex Medical Research Studies

Rank Status Study
1 Recruiting SFERA Study: Prospective, Single-arm, Open-label, Multi-center, Interventional Phase IV Study
Conditions: Relapsing-Remitting Multiple Sclerosis;   Clinical Isolated Syndrome (CIS);   Multiple Sclerosis
Intervention: Device: Interferon-beta-1a
Outcome Measures: The percent change from baseline in Visual Analogue Scale score of injection site tolerability;   The percent change from baseline in Visual Analogue Scale score of systemic tolerability;   The percentage of participants still on Avonex Pen;   Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores;   The percentage of missed injections;   Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score
2 Recruiting Rebif® Rebidose® Versus Rebiject II® Ease-of-Use
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Device: Rebif® Rebidose®;   Device: Rebiject II®
Outcome Measures: Percentage of subjects rating the device as easy to use;   Percentage of subjects rating the device based on User Trial Questionnaire (UTQ);   Percentage of subjects rating the device as very difficult, difficult, neither easy nor difficult, easy, or very easy;   Change from Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) score at Weeks 4 and 8
3 Recruiting Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
Condition: Multiple Sclerosis
Interventions: Drug: BIIB033;   Other: Placebo;   Drug: Interferon Beta-1a
Outcome Measures: Percentage of subjects experiencing confirmed improvement of neuro-physical and/or cognitive function and/or disability.;   Percentage of subjects experiencing confirmed worsening of neuro-physical and/or cognitive function and/or disability;   Number of participants with Adverse events (AEs) and serious adverse events (SAEs);   BIIB033 population Pharmacokinetics assessment
4 Not yet recruiting A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
Intervention: Drug: Rebif®
Outcome Measures: Flu-like Symptoms (FLS) score at Week 12;   Flu-like Symptoms (FLS) score at Weeks 4 and 8;   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale scores at Weeks 4, 8 and 12;   Change from Baseline in Hospital Anxiety and Depression Scale (HADS) subscale and total score at Weeks 4, 8 and 12;   Change from Baseline in Fatigue Severity Scale (FSS) score at Weeks 4, 8 and 12;   Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) score at Weeks 4, 8 and 12;   Change from Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) score at Weeks 4, 8 and 12;   Percentage of subjects with adherence to treatment;   Change from Baseline in circulating levels of cytokines at Week 12;   Number of Subjects With Treatment-Emergent Adverse Events (TEAEs);   Correlation between change from Baseline in circulating levels of cytokines at Week 12 and FLS score
5 Not yet recruiting RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
Condition: Multiple Sclerosis
Intervention: Drug: Rebif®
Outcome Measures: Change from baseline in Treatment satisfaction score determined by the global satisfaction sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24;   Change from baseline in Patient-Determined Disease Steps Questionnaire (PDDS) score at Week 24;   Change from baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) score at Week 24;   Change from baseline in TSQM (Version II) - Total score at Week 12 and Week 24;   Change from baseline in TSQM (Version II) - Medication effectiveness, side effects, and convenience subscale scores at Week 24;   Change from baseline in TSQM (Version II) - Global satisfaction, medication effectiveness, side effects, and convenience subscale scores at Week 12;   Change from baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) questionnaire score at Week 24;   Change From Baseline in number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24;   Annualized Relapse Rate (ARR)
6 Recruiting Assessing Tolerability of Avonex Intramuscular Injections
Condition: Multiple Sclerosis
Intervention: Drug: Avonex
Outcome Measures: Change in patient VAS score;   Ease of use
7 Unknown  A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention: Drug: Avonex and Topamax
Outcome Measures: Safety and tolerability;   Brain atrophy on nMRI;   Disease progression on EDSS and MSFC;   Relapse rate
8 Not yet recruiting Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
Interventions: Drug: RNS60 125 ml;   Drug: RNS60 250 ml;   Drug: Interferon beta 1a
Outcome Measures: Change in number of GAD-enhancing lesions from baseline;   Change in number of T2 lesions from baseline;   Brain volume;   T2 lesion volume;   Annualized Relapse Rate;   Expanded Disability Status Scale (EDSS), change from baseline;   Multiple Sclerosis Functional Composite, change from baseline
9 Recruiting Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a
Condition: Multiple Sclerosis
Interventions: Drug: IFN beta 1 a + curcumin (BCM 95);   Drug: IFN beta-1a + placebo
Outcome Measures: Difference between the proportion of subjects with active T2 lesions assessed by MRI in both examined arms at Month 12;   Proportion of relapse-free subjects at Month 12;   Proportion of relapse-free subjects at Month 24;   Time to first documented relapse;   Proportion of subjects treated with glucocorticoids due to relapses;   Time to confirmed Expanded Disability Status Scale (EDSS) progression at 12 months;   Time to confirmed Expanded Disability Status Scale (EDSS) progression at 24 months;   Proportion of subjects free from confirmed EDSS progression at 12 months;   Proportion of subjects free from confirmed EDSS progression at 24 months;   Mean number of Combined Unique Active (CUA) lesions per subject per MRI scan at Month 12;   Mean number of Combined Unique Active (CUA) lesions per subject per MRI scan at Month 24;   Mean number of new Gd-enhancing lesions per subject assessed by MRI at Month 12;   Mean number of new Gd-enhancing lesions per subject assessed by MRI at Month 24;   Frequency and severity of flu-like symptoms (FLS) as measured by FLS scale
10 Recruiting Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
Interventions: Drug: Interferon beta-1a i.m. injections;   Drug: Fingolimod oral capsules;   Drug: Placebo oral capsule;   Drug: Placebo i.m. injection
Outcome Measures: Frequency of relapses" in patients treated for up to 24 months;   Number of new/newly enlarged T2 (n/neT2) lesions;   Frequency and nature of adverse events as a measure of Safety and Tolerability;   Pharmacokinetics (Cavg)of fingolimod and fingolimod-P
11 Recruiting A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device
Conditions: Multiple Sclerosis;   Relapsing-Remitting
Interventions: Other: Technical support for the RebiSmart™ device;   Other: Patient support program (MinSupport Plus)
Outcome Measures: Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) psychological score at Month 12;   Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) psychological score at Month 6;   Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) total score at Month 6 and 12;   Change from Baseline in Euro Quality of Life Questionnaire with 5 questions alternatives (EQ5D-5L) score at Month 6 and 12;   Percentage of subjects with treatment adherence;   Change from Baseline in Fatigue Severity Scale score and Modified Fatigue Impact Scale score at Month 6 and 12;   Change from Baseline in Hospital Anxiety and Depression Scale score at Month 6 and 12;   Change from Baseline in Working ability per subject at Month 12;   Percentage of subjects with Adverse events;   Number of subjects with categorical score on subject satisfaction questionnaire;   Number of health care personnel with categorical score on Health Care Personnel satisfaction questionnaire;   Change from Baseline in Lifestyle questionnaire score in subjects receiving Min Support Plus at Month 6 and 12;   Number of subjects with Lifestyle goals score in subjects receiving Min Support Plus;   Health economy as assessed by Quality of life questionnaire
12 Recruiting Canadian Avonex PEN Productivity Study
Condition: Multiple Sclerosis
Intervention:
Outcome Measures: Effect of MS on patients' ability to work and perform regular activities, its change from baseline and its correlation rate with all secondary outcomes;   Hospital and emergency episodes of care;   Number of missed injections;   Patients drop-off rate;   Quality of life scores and their change from baseline;   Patients' satisfaction with the device and its change from baseline;   Ease of use of the device and its change from baseline;   Injection site reactions (ISRs) type and frequency as reported by healthcare professionals and patients to the Sponsor's adverse event (AE) reporting system
13 Recruiting Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: RHB-104
Outcome Measure: Combined Unique Active lesions
14 Unknown  Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients
Condition: Multiple Sclerosis
Interventions: Drug: estroprogestins;   Drug: interferon-beta 1a
Outcome Measures: Safety assessment at 6, 12, 18 and 24 months, including adverse events, physical examination and laboratory parameters;   Relapse rate at 6, 12, 18 and 24 months,;   EDSS progression at 12 and 24 months,;   MS functional composite score at 12 and 24 months,;   Number and volume of new gad-enhancing lesions at 12 and 24 months;   Number of new T1 and T2 lesions at 12 and 24 months;   Brain volume changes at 12 and 24 months;   Neuropsychological examination at 0, 12, 24 months;   Hamilton scale for depression score at 0, 12, 24 months;   MS Quality of Life scale score(MSQOL54)at 0, 12, 24 months;   Fatigue Severity Scale score at 0, 12, 24 months
15 Unknown  Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: BIIB017
Outcome Measures: To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms.;   To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms.;   Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms.;   Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.;   Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.;   Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.;   Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.;   Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.;   Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms.;   Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.;   Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.;   Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.
16 Unknown  Combination Therapy (Provigil + Avonex) to Treat Cognitive Problems in MS
Condition: Relapsing-Remitting Multiple Sclerosis
Intervention: Drug: Provigil (modafinil)
Outcome Measures: Comparison of AE's and SAE's to determine safety of combination;   Full neuropsychological test battery (including fatigue measures) to assess effect on fatigue and cognition.
17 Unknown  The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
Intervention: Drug: lamotrigine
Outcome Measures: N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy;   Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.;   relapse rate;   Expanded disability status score;   Fatigue Severity Score
18 Unknown  A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: Simvastatin
Outcome Measures: 1. To evaluate the safety of combining Avonex with Zocor for a period of fourteen months in patients with RRMS;   2. To evaluate the effect of treatment on MRI, specifically new or enlarging T2 lesions burden;   1. To evaluate the effect on Relapse Rates;   2. To evaluate the effect on disease progression as measured with EDSS and MSFC
19 Unknown  Avonex-evaluation of Quality of Life and Convenience in Belgian Patients - The AVAIL Study
Condition: Multiple Sclerosis
Intervention:
Outcome Measures: Quality of life;   Convenience
20 Recruiting Adherence Trial With MS LifeLines ® Services
Conditions: Multiple Sclerosis;   Relapsing-Remitting
Interventions: Other: Standard Services of Group A (Group A1);   Other: Customized Services of Group A (Group A2);   Other: Group B
Outcome Measures: Subject-reported adherence to treatment, calculated as percent adherence ([number of actual injections / number of expected injections] * 100), for subjects in the Group A1 compared with subjects in the Group A2;   Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Month 12;   Subject-reported adherence to treatment in Group A1, Group A2 and Group B at Months 3 and 6;   Subject-reported Multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B;   Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B;   Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B;   Subject-reported Multiple Sclerosis International Quality of Life (MusiQoL) in Group A1, Group A2 and Group B;   Subject-reported Morisky Medication Adherence Scale-4 (MMAS-4) in Group A1, Group A2 and Group B;   Change from Baseline in Subject-reported multiple Sclerosis Rating Scale- Revised (MSRS-R) in Group A1, Group A2 and Group B at Months 6 and 12;   Change from Baseline in Subject-reported Patient-determined Disease Steps Questionnaire (PDDS) in Group A1, Group A2 and Group B at Months 6 and 12;   Change from Baseline in Subject-reported Multiple Sclerosis Self-management Scale - Revised (MSSM-R) in Group A1, Group A2 and Group B at Months 6 and 12;   Change from Baseline in Subject-reported Multiple Sclerosis International Quality of Life (MusiQoL) in Group A1, Group A2 and Group B at Months 6 and 12;   Change from Baseline in Subject-reported score in Morisky Medication Adherence Scale-4 (MMAS-4) in Group A1, Group A2 and Group B at Months 2, 6, 9 and 12;   Percentage of subjects who dropped-out of the trial along with the reasons of dropping out in Group A1, Group A2 and Group B;   Percentage of subjects with more than 80 percent and 90 percent subject-reported adherence to treatment in Group A1, Group A2 and Group B;   Percentage of subject demographic characteristics in Group A1, Group A2 and Group B

These studies may lead to new treatments and are adding insight into Avonex etiology and treatment.

A major focus of Avonex research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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