Multiple Sclerosis, Relapsing-RemittingPhase 2NCT00676715
A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 2 study testing Ocrelizumab and Avonex in people with Multiple Sclerosis, Relapsing-Remitting, run by Genentech, Inc. at 84 sites in 18 countries.
Trial summary
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis… 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?
- Ocrelizumab and Avonex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 84 sitesin 18 countries
- Study dates
- 17 Jul 2008to 8 Nov 2023
- Phase
- Phase 2
- 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
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Relapsing-remitting multiple sclerosis (MS)
- Ages 18-55 years inclusive
- For sexually active female and male participants of reproductive potential, use of reliable means of contraception
Who cannot join
- Secondary or primary progressive multiple sclerosis at screening
- Incompatibility with MRI
- Contra-indications to or intolerance of oral or IV corticosteroids
- Known presence of other neurologic disorders
- Pregnancy or lactation
- Lack of peripheral venous access
Show all 23Show fewer
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
- History or known presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
- History of alcohol or drug abuse within 24 weeks prior to randomization
- History of or currently active primary or secondary immunodeficiency
- History of coagulation disorders
- Treatment with any investigational agent within 4 weeks of screening
- Receipt of a live vaccine within 6 weeks prior to randomization
- Incompatibility with Avonex use
- Previous treatment with rituximab
- Previous treatment with lymphocyte-depleting therapies except mitoxantrone
- Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
- Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
- Systemic corticosteroid therapy within 4 weeks prior to randomization
Trial locations and contacts
84 sites in 18 countries.
84 sites in 18 countries
United States26 sites
Shepherd Center; Multiple Sclerosis Center
Atlanta, Georgia, 30309
John Hopkins University
Baltimore, Maryland, 21205
East Bay Physicians Med Group;Sutter East Bay Med Foundation
Berkeley, California, 94705
Bradenton Research Center
Bradenton, Florida, 34205
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, 5405
The Neurological Institute PA
Charlotte, North Carolina, 28204
University of Virginia - Fontain Research Park
Charlottesville, Virginia, 22903
University of Chicago; Neurology
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44106
Ohio State University Med Ctr; MS Center
Columbus, Ohio, 43221
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, 48334
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, 80528
Baylor College of Medicine
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66103
Dartmouth-Hitchcock Medical Center; Dept of Neurology
Lebanon, New Hampshire, 03756
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Columbia University Medical Center; The Neurological Institute of New York
New York, New York, 10032
Phoenix Neurological Associates Ltd
Phoenix, Arizona, 85006
Barrow Neurological Institute
Phoenix, Arizona, 85013
Island Neurological Associates, P.C.
Plainview, New York, 11803
Integra Clinical Research, Llc
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94117
Suny At Stony Brook; Department Of Neurology
Stony Brook, New York, 11794
Legacy Health System; Clinical Research & Tech Ctr
Tualatin, Oregon, 97062
MS Center of Vero Beach
Vero Beach, Florida, 32960
Clinical Research of Winston Salem
Winston-Salem, North Carolina, 27103
Bulgaria6 sites
First MHAT; Clinic of Neurology
Sofia, 1000
Shat of Cardiovascular Diseases; Clinic of Neurology
Sofia, 1309
ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
Sofia, 1407
UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
Sofia, 1527
CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
Sofia, 1606
Military Medical Academy; Neurology
Sofia, 1606
Russia6 sites
LLC Research Medical Complex Vashe Zdorovie
Kazan', Tatarstan Republic, 4420029
Central Clinical Hospital #2 N.A. Semashko OAO RJHD
Moskva, Moscow Oblast, 107150
Municipal City Hospital #33; Neurology
Nizhny Novgorod, Niznij Novgorod, 603076
MRC for Oncology and Neurology; Neurology
Novosibirsk, 630090
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen, Tyumen Oblast, 625048
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
Yekaterinburg, Sverdlovsk Oblast, 620102
Spain6 sites
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
Barcelona, 08035
Hospital Clinic i Provincial; Servicio de Neurologia
Barcelona, 08036
Hospital Ramon y Cajal; Servicio de Neurologia
Madrid, 28034
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Málaga, 29010
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville, 41009
Hospital Universitario La Fe; Unidad de Esclerosis Multiple
Valencia, 46026
Slovakia5 sites
Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
Banská Bystrica, 975 17
Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
Bratislava, 813 69
Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
Košice, 041 66
Fakultna Nemocnica Nitra; Neurologicka Klinika
Nitra, 949 01
Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
Spišská Nová Ves, 05201
Czechia4 sites
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
Ostrava, 708 52
Krajska Nemocnice Pardubice Neurologicka Klinika
Pardubice, 532 03
Fakultni nemocnice Motol; Neurologicka klinika
Prague, 150 06
Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
Teplice, 415 29
France4 sites
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux, 33076
CHU De Caen; Service De Neurologie Dejerine
Caen, 14033
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, 63003
CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
Nîmes, 30029
Germany4 sites
St. Joseph-Krankenhaus
Berlin, 13088
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, 13347
Asklepios Klinik Nord-Heidberg; Neurologie
Hamburg, 22417
Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
Marburg, 35039
Mexico4 sites
Instituto Biomedico De Investigacion A.C.
Aguascalientes, 20127
Unidad de Investigacion CIMA SC
Chihuahua City, 31200
Hospital Cima Chihauhau
Chihuahua City, 31328
Hospital CIMA, Sta. Engracia
Monterrey, Nuevo León, 64060
Ukraine4 sites
Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
Kharkiv, 61068
City Clin.Hosp #4; Dept. of Neurology
Kyiv, 03110
Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
Propetrovsk, 49027
Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
Vinnytsia, 21005
Canada3 sites
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, H3A 2B4
St. Michael'S Hospital
Toronto, Ontario, M5B 1W8
Uni of British Columbia Hospital; Ms Clinical Research Group
Vancouver, British Columbia, V6T 2B5
Serbia3 sites
Clinical Center of Serbia; Institute of Neurology
Belgrade, 11000
Clinical Center Nis; Clinic for Mental Health
Niš, 18000
Clinic of Neurology
Nova Sad, 21000
United Kingdom3 sites
Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
Liverpool, L9 7LJ
Uni Hospital Queens Medical Centre; Neurology
Nottingham, NG7 2UH
Royal Hallamshire Hospital; Neurology
Sheffield, S10 2JF
Romania2 sites
Spitalul Clinic Colentina; Clinica de Neurologie
Bucharest, 020125
Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
Târgu Mureş, 540136
Denmark1 site
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
Aarhus N, 8200
Italy1 site
Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
Rome, Lazio, 00189
About this study
Official title: Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Placebo, Ocrelizumab, Avonex
- 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.
PlaceboDrug
Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.
OcrelizumabDrug
Also called RO4964913
Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.
AvonexDrug
Also called Interferon-beta-alpha1
Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days. Receives: Drug: Placebo |
| Ocrelizumab 600 mg | Experimental | Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days. Receives: Drug: Ocrelizumab |
| Ocrelizumab 1000 mg | Experimental | Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days. Receives: Drug: Ocrelizumab |
| Avonex | Active comparator | Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days. Receives: Drug: Avonex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
Measured: Week 12 to Week 24
Secondary outcomes (5)
Annualized Protocol Defined Relapse Rate at Week 24
Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.
Measured: Week 24
Percentage of Participants Who Remained Relapse Free at Week 24
Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.
Measured: Week 24
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.
Measured: Baseline, Week 24
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.
Measured: Weeks 4 to Week 24
Total Number of Gadolinium-Enhancing T1 Lesions
Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.
Measured: Weeks 4 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study start17 Jul 2008
- Primary completion9 Mar 2012
- Study completion8 Nov 2023
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 Genentech, Inc.The 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676715
- Sponsor's protocol ID
- ACT4422g
- Other IDs
- 2007-006338-32, WA21493
- Status last verified
- Dec 2024
- First submitted
- 9 May 2008
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.
PubMed 22047971
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS
- ClinicalTrials.gov ID
- NCT00676715
- Acronym / sponsor ID
- ACT4422g
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Study start
- 17 Jul 2008 (actual)
- Primary completion
- 9 Mar 2012 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days. |
| Ocrelizumab 600 mg | Experimental | Drug: OcrelizumabParticipants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days. |
| Ocrelizumab 1000 mg | Experimental | Drug: OcrelizumabParticipants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days. |
| Avonex | Active comparator | Drug: AvonexParticipants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Relapsing-remitting multiple sclerosis (MS)
- Ages 18-55 years inclusive
- For sexually active female and male participants of reproductive potential, use of reliable means of contraception
Key exclusion criteria (23 listed)
- Secondary or primary progressive multiple sclerosis at screening
- Incompatibility with MRI
- Contra-indications to or intolerance of oral or IV corticosteroids
- Known presence of other neurologic disorders
- Pregnancy or lactation
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 |
|---|---|---|
| PlaceboPlacebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1. | Drug | Placebo |
| OcrelizumabAlso: RO4964913Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. | Drug | Ocrelizumab 1000 mg, Ocrelizumab 600 mg |
| AvonexAlso: Interferon-beta-alpha1Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1. | Drug | Avonex |
Primary outcome
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
Time frame: Week 12 to Week 24
Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.
5 secondary outcomes
Annualized Protocol Defined Relapse Rate at Week 24
Time frame: Week 24
Percentage of Participants Who Remained Relapse Free at Week 24
Time frame: Week 24
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
Time frame: Baseline, Week 24
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
Time frame: Weeks 4 to Week 24
Total Number of Gadolinium-Enhancing T1 Lesions
Time frame: Weeks 4 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22047971Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31.
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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.
Clinical Trials study director
Genentech, Inc.
84 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ocrelizumab and Avonex in people with Multiple Sclerosis, Relapsing-Remitting, run by Genentech, Inc. at 84 sites in 18 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 4 inclusion and 23 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Bulgaria, Russia, Spain, Slovakia and 13 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 May 2017). 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?
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (time frame: Week 12 to Week 24). 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 NCT00676715, 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 31 Dec 2024.