Multiple Sclerosis, Relapsing-RemittingPhase 3BeyondNCT00459667
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
A Phase 3 study testing Interferon beta-1b (Betaseron, BAY86-5046) in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 184 sites in 26 countries.
Trial summary
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment. 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?
- Interferon beta-1b (Betaseron, BAY86-5046)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,420 participants
- Where
- 184 sitesin 26 countries
- Study dates
- May 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completion of the BEYOND study 306440 as scheduled
- Relapsing multiple sclerosis
- Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
- Females of child-bearing potential:
- Agreement to practice adequate contraception methods and
- Negative pregnancy test and
- No lactation
- Written informed consent
Who cannot join
- Serious or acute heart diseases
- History of severe depression or suicide attempt
- Epilepsy not adequately controlled by treatment
- Known allergy to IFNs, to human albumin or to mannitol
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
Trial locations and contacts
184 sites in 26 countries.
184 sites in 26 countries
United States51 sites
Study site
Albuquerque, New Mexico, 87131-5281
Study site
Atlanta, Georgia, 30309-1465
Study site
Augusta, Georgia, 30912
Study site
Berkeley, California, 94705
Study site
Birmingham, Alabama, 35294-7340
Study site
Charleston, South Carolina, 29425
Study site
Charlotte, North Carolina, 28207
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45219
Study site
Columbus, Ohio, 43210
Study site
Cullman, Alabama, 35058
Study site
Des Moines, Iowa, 50314
Study site
Detroit, Michigan, 48202
Study site
Duluth, Minnesota, 55805
Study site
Durham, North Carolina, 27710
Study site
Fairfax, Virginia, 22031
Study site
Fort Collins, Colorado, 80528
Study site
Fort Wayne, Indiana, 46805
Study site
Henderson, Nevada, 89052
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Kansas City, Kansas, 66160
Study site
La Jolla, California, 92037
Study site
Louisville, Kentucky, 40202
Study site
Maitland, Florida, 32751
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53215
Study site
Mineola, New York, 11501
Study site
Nashville, Tennessee, 37205
Study site
Newark, Delaware, 19713
Study site
Newark, New Jersey, 07103
Study site
Philadelphia, Pennsylvania, 19104
Study site
Phoenix, Arizona, 85013
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Providence, Rhode Island, 02905
Study site
Reno, Nevada, 89509
Study site
Rochester, New York, 14642
Study site
Sacramento, California, 95817
Study site
San Antonio, Texas, 78229
Study site
San Francisco, California, 94117
Study site
Seattle, Washington, 98101
Study site
Shreveport, Louisiana, 71130
Study site
St Louis, Missouri, 63110
Study site
Stony Brook, New York, 11794
Study site
Tacoma, Washington, 98405
Study site
Tampa, Florida, 33606
Study site
Tampa, Florida, 33609
Study site
Tualatin, Oregon, 97062
Study site
Tucson, Arizona, 85741
Study site
Washington D.C., District of Columbia, 20037
Study site
Winston-Salem, North Carolina, 27157
Germany21 sites
Study site
Bayreuth, Bavaria, 95445
Study site
Berlin, State of Berlin, 13347
Study site
Berlin, State of Berlin, 13585
Study site
Dresden, Saxony, 01307
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Study site
Essen, North Rhine-Westphalia, 45117
Study site
Giessen, Hesse, 35392
Study site
Göttingen, Lower Saxony, 37099
Study site
Greifswald, Mecklenburg-Vorpommern, 17475
Study site
Halle, Saxony-Anhalt, 06120
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20099
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Hanover, Lower Saxony, 30559
Study site
Hanover, Lower Saxony, 30625
Study site
Heidelberg, Baden-Wurttemberg, 69120
Study site
Hennigsdorf, Brandenburg, 16761
Study site
Leipzig, Saxony, 04129
Study site
Marburg, Hesse, 35039
Study site
Münster, North Rhine-Westphalia, 48149
Study site
Offenbach, Hesse, 63069
Study site
Regensburg, Bavaria, 93053
Canada12 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Halifax, Nova Scotia, B3H 2Y9
Study site
Hull, Quebec, J8Y 1W7
Study site
London, Ontario, N6A 5A5
Study site
Mississauga, Ontario, L5B 1B8
Study site
Montreal, Quebec, H2L 4M1
Study site
Montreal, Quebec, H3A 2B4
Study site
Nepean, Ontario, K2G 6E2
Study site
Ottawa, Ontario, K1H 8L6
Study site
Toronto, Ontario, M5B 1W8
Study site
Vancouver, British Columbia, V6T 2B5
Russia11 sites
Study site
Moskva, 117049
Study site
Moskva, 118089
Study site
Moskva, 123367
Study site
Moskva, 127018
Study site
Moskva, 129110
Study site
Nizhy Novgorod, 603076
Study site
Novosibirsk, 630007
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197376
Study site
Yaroslavl, 150039
France10 sites
Study site
Bordeaux, Gironde, 33076
Study site
Clermont-Ferrand, 63003
Study site
Dijon, 21033
Study site
Lille, 59037
Study site
Nancy, 54035
Study site
Nantes, 44093
Study site
Nice, 06000
Study site
Nîmes, 30029
Study site
Rennes, Brittany Region, 35038
Study site
Toulouse, 31059
Brazil8 sites
Study site
Campinas, São Paulo, 13081- 970
Study site
Curitiba, Paraná, 80240-340
Study site
Porto Alegre, Rio Grande do Sul, 90035-001
Study site
Recife, Pernambuco, 52010-040
Study site
Rio de Janeiro, Rio de Janeiro, 21941-590
Study site
São Paulo, São Paulo, 01221-020
Study site
São Paulo, São Paulo, 04039-032
Study site
São Paulo, São Paulo, 05403-900
Poland7 sites
Study site
Gdansk, 80-803
Study site
Katowice, 40752
Study site
Lodz, 90153
Study site
Poznan, 61848
Study site
Warsaw, 02097
Study site
Warsaw, 02957
Study site
Wroclaw, 50420
Argentina6 sites
Study site
Buenos Aires, Buenos Aires, C1416CRJ
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1117ABE
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB
Study site
Córdoba, Córdoba Province, X5000HGX
Study site
Rosario, Santa Fe Province, S2000ZBL
Study site
Rosario, Santa Fe Province
Australia6 sites
Study site
Fitzroy, Victoria, 3065
Study site
Kogarah, New South Wales, 2217
Study site
Liverpool, NSW 2170
Study site
Nedlands, Western Australia, 6009
Study site
Parkville, Victoria, 3050
Study site
Wyoming, NSW 2250
Hungary6 sites
Study site
Budapest, 1076
Study site
Budapest, 1145
Study site
Győr, 9024
Study site
Miskolc, 3501
Study site
Pécs, 7623
Study site
Zalaegerszeg-Pozva, H-8900
Israel6 sites
Study site
Ashkelon, 78278
Study site
Haifa, 31048
Study site
Jerusalem, 91120
Study site
Tel Aviv, Israel, 64239
Study site
Tel HaShomer, Israel, 52621
Study site
Tsrifin, Israel, 70300
Italy6 sites
Study site
Bari, 70122
Study site
Florence, 50134
Study site
Milan, 20132
Study site
Orbassano, Torino, 10043
Study site
Padova, 35128
Study site
Roma, 00189
Austria4 sites
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Linz, 4020
Study site
Sankt Pölten, Lower Austria, A-3100
Ireland4 sites
Study site
Cork
Study site
Dublin, Dublin
Study site
Dublin, 4
Study site
Dublin, 9
Ukraine4 sites
Study site
Donetsk, 83003
Study site
Kharkiv, 61068
Study site
Kiev, 03110
Study site
Lviv, 79000
Belgium3 sites
Study site
Brussels, 1090
Study site
Leuven, 3000
Study site
Melsbroek, 1820
Netherlands3 sites
Study site
Breda, 4819 EV
Study site
Nijmegen, 6533 PA
Study site
Sittard, 6131 BK
Spain3 sites
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Málaga, 29010
Study site
Seville, 41071
About this study
Official title: International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.
Read the detailed description
Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.
Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)
Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.
The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.
Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Interferon beta-1b (Betaseron, BAY86-5046)
- Keywords
- Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).
Interferon beta-1b (Betaseron, BAY86-5046)Drug
Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.
Phase B: All patients will receive 500µg s.c.every other day (open-label).
| Study group | Role | What they receive |
|---|---|---|
| IFNB-1b 500 mcg | Experimental | Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind) Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
| IFNB-1b 250 mcg | Experimental | Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind) Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
| IFNB-1b 250 mcg* | Experimental | Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day
*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.) Receives: Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu-like-syndrome
The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
Measured: 309 days
Injection-site Reactions
The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Measured: 309 days
Liver Enzyme Elevations
The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Measured: 309 days
Hematological Abnormalities
The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Measured: 309 days
Secondary outcomes (1)
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.
Measured: 309 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BayerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459667
- Sponsor's protocol ID
- 91656
- Other IDs
- 2006-005270-47, 309363
- Acronym
- Beyond
- Status last verified
- Apr 2015
- First submitted
- 11 Apr 2007
- Last updated
- 23 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.
PubMed 21952094
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg
- ClinicalTrials.gov ID
- NCT00459667
- Acronym / sponsor ID
- Beyond / 91656
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,420 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Posted 17 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.
Detailed description
Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.
Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)
Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.
The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.
Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IFNB-1b 500 mcg | Experimental | Drug: Interferon beta-1b (Betaseron, BAY86-5046)Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind) |
| IFNB-1b 250 mcg | Experimental | Drug: Interferon beta-1b (Betaseron, BAY86-5046)Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind) |
| IFNB-1b 250 mcg* | Experimental | Drug: Interferon beta-1b (Betaseron, BAY86-5046)Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day *(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Completion of the BEYOND study 306440 as scheduled
- Relapsing multiple sclerosis
- Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
- Females of child-bearing potential:
- Written informed consent
Key exclusion criteria (5 listed)
- Serious or acute heart diseases
- History of severe depression or suicide attempt
- Epilepsy not adequately controlled by treatment
- Known allergy to IFNs, to human albumin or to mannitol
- Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
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 |
|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046)Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). | Drug | IFNB-1b 250 mcg |
| Interferon beta-1b (Betaseron, BAY86-5046)Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). | Drug | IFNB-1b 500 mcg |
| Interferon beta-1b (Betaseron, BAY86-5046)Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162. Phase B: All patients will receive 500µg s.c.every other day (open-label). | Drug | IFNB-1b 250 mcg* |
Primary outcome
Flu-like-syndrome
Time frame: 309 days
The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
Injection-site Reactions
Time frame: 309 days
The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Liver Enzyme Elevations
Time frame: 309 days
The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Hematological Abnormalities
Time frame: 309 days
The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
1 secondary outcome
Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
Time frame: 309 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21952094Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
Bayer Study Director study director
Bayer
184 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon beta-1b (Betaseron, BAY86-5046) in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 184 sites in 26 countries.
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 5 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 184 sites in United States, Germany, Canada, Russia, France and 21 more countries. 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 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?
Yes. Results are posted in the registry (first posted 17 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flu-like-syndrome (time frame: 309 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459667, which also lists 1 linked publication.
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 23 Apr 2015.