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Multiple SclerosisPhase 3BRAVONCT00605215

BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)

A Phase 3 study testing Laquinimod and Avonex® in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 170 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Laquinimod and Avonex®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,331 participants
Where
170 sitesin 19 countries
Study dates
24 Apr 2008to 10 Jun 2011
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

  • Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846], with a relapsing-remitting disease course.
  • Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.5.
  • Subjects must be in a stable neurological condition between screening (month -1) and baseline visits (month 0).
  • Subjects must have had experienced one of the following:
  • At least one documented relapse in the 12 months prior to screening
  • At least two documented relapses in the 24 months prior to screening
Show all 11Show fewer
  • One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
  • Subjects must be between 18 and 55 years of age, inclusive.
  • Subjects must have disease duration of at least 6 months (from first symptom) prior to screening.
  • Women of child-bearing potential must practice 2 acceptable methods of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or double-barrier method (condom or diaphragm with spermicide)].
  • Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Who cannot join

  • An onset of relapse or any treatment with corticosteroids (intravenous [iv], intramuscular [im] and/or per os [po]) or ACTH between month -1 (screening) and 0 (baseline).
  • Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
  • Use of immunosuppressive (including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
  • Previous use of either of the following: natalizumab (Tysabri®), cladribine or laquinimod.
  • Previous treatment with glatiramer acetate (Copaxone®) or IVIG within 3 months prior to screening visit.
  • Previous treatment with Interferon beta-1a (Avonex® or Rebif®) or Interferon beta-1b (Betaseron®).
Show all 41Show fewer
  • Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
  • Previous total body irradiation or total lymphoid irradiation.
  • Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  • A known history of tuberculosis.
  • Acute infection 2 weeks prior to baseline visit.
  • Major trauma or surgery 2 weeks prior to baseline visit.
  • A history of vascular thrombosis (excluding catheter-site superficial venous thrombophlebitis).
  • A carrier state of factor V Leiden mutation (either homo- or heterozygous) by history or as disclosed at screening.
  • Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody as disclosed at screening visit.
  • Use of potent inhibitors of CYP3A4 within 2 weeks prior to baseline visit (see detailed list of drugs in protocol) (1 month for fluoxetine).
  • Use of amiodarone within 2 years prior to screening visit.
  • Pregnancy or breastfeeding.
  • Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include:
  • A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
  • A gastrointestinal disorder that may affect the absorption of study medication.
  • Renal, metabolic, endocrinological or hematological diseases.
  • Any form of chronic liver disease, including known non-alcoholic steatohepatitis.
  • A ≥2xULN serum elevation of either of the following at screening: ALT, AST or direct bilirubin.
  • A QTc interval (obtained from either two ECG recordings at screening or from the mean value calculated from three measurements at baseline visit) which is ≥450msec.
  • A family history of Long-QT syndrome.
  • A history of drug and/or alcohol abuse.
  • Major psychiatric disorder.
  • A history of a convulsive disorder.
  • Known hypersensitivity to either of the following: mannitol, meglumine or sodium stearyl fumarate.
  • Known hypersensitivity that would preclude administration of laquinimod.
  • The subject's inability to give informed consent, or to complete the study, or if the subject is considered by the investigator to be, for any reason, an unsuitable candidate for this study.
  • A known history of sensitivity to Gadolinium.
  • Inability to successfully undergo MRI scanning.
  • A known history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation of Avonex®.
  • Subjects who suffer from any form of progressive MS
  • Any condition which the investigator feels may interfere with participation in the study
  • Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
  • Subjects who received any investigational medication, immunosuppressives or cytotoxic agents within 6 months prior to screening
  • Previous treatment with immunomodulators within two months prior to screening
  • Pregnancy or breastfeeding

Trial locations and contacts

170 sites in 19 countries.

170 sites in 19 countries

United States36 sites

  • Teva Investigational Site 1261

    Akron, Ohio, 44320

  • Teva Investigational Site 1273

    Albany, New York, 12205

  • Teva Investigational Site 1264

    Amherst, New York, 14226

  • Teva Investigational Site 1275

    Atlanta, Georgia, 30309

  • Teva Investigational Site 1280

    Aurora, Colorado, 80045

  • Teva Investigational Site 1269

    Baltimore, Maryland, 21201

  • Teva Investigational Site 1267

    Birmingham, Alabama, 35209

  • Teva Investigational Site 1241

    Canton, Ohio, 44718

  • Teva Investigational Site 1283

    Cedarhurst, New York, 11516

  • Teva Investigational Site 1245

    Cleveland, Ohio, 44195-5244

  • Teva Investigational Site 1247

    Columbus, Ohio, 43221

  • Teva Investigational Site 1274

    Grand Rapids, Michigan, 49525

  • Teva Investigational Site 1260

    Indianapolis, Indiana, 46202

  • Teva Investigational Site 1239

    Lebanon, New Hampshire, 03766

  • Teva Investigational Site 1268

    Lenexa, Kansas, 66214

  • Teva Investigational Site 1281

    Nashville, Tennessee, 37205

  • Teva Investigational Site 1277

    New Orleans, Louisiana, 70115

  • Teva Investigational Site 1255

    Orlando, Florida, 32806

  • Teva Investigational Site 1272

    Pasadena, California, 91105

  • Teva Investigational Site 1250

    Peoria, Illinois, 61603

  • Teva Investigational Site 1258

    Philadelphia, Pennsylvania, 19107

  • Teva Investigational Site 1237

    Phoenix, Arizona, 85013

  • Teva Investigational Site 1252

    Phoenix, Arizona, 85018

  • Teva Investigational Site 1279

    Phoenix, Arizona, 85018

  • Teva Investigational Site 1244

    Portland, Oregon, 97225

  • Teva Investigational Site 1249

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 1248

    Richmond, Virginia, 23298-0599

  • Teva Investigational Site 1270

    Roanoke, Virginia, 24018

  • Teva Investigational Site 1238

    Sacramento, California, 95817

  • Teva Investigational Site 1284

    San Antonio, Texas, 78231

  • Teva Investigational Site 1282

    Sarasota, Florida, 34233

  • Teva Investigational Site 1263

    Shreveport, Louisiana, 71103

  • Teva Investigational Site 1253

    Tacoma, Washington, 98405

  • Teva Investigational Site 1265

    Teaneck, New Jersey, 07666

  • Teva Investigational Site 1276

    Tucson, Arizona, 85741-3537

  • Teva Investigational Site 1262

    Winston-Salem, North Carolina, 27103

Other trials in United States

Poland18 sites

  • Teva Investigational Site 5337

    Bialystok, 15-402

  • Teva Investigational Site 5329

    Gdansk, 80-803

  • Teva Investigational Site 5338

    Gdansk, 80-952

  • Teva Investigational Site 4213

    Gmina Końskie, 26-200

  • Teva Investigational Site 6602

    Gorzów Wielkopolski, 66-400

  • Teva Investigational Site 5333

    Grodzisk Mazowiecki, 05-825

  • Teva Investigational Site 5339

    Katowice, 40-635

  • Teva Investigational Site 5334

    Katowice, 40-752

  • Teva Investigational Site 6603

    Kielce, 25-736

  • Teva Investigational Site 5332

    Kościerzyna, 83-400

  • Teva Investigational Site 5345

    Krakow, 31-826

  • Teva Investigational Site 5328

    Lodz, 90-153

  • Teva Investigational Site 5330

    Olsztyn, 10-560

  • Teva Investigational Site 5331

    Szczecin, 70-215

  • Teva Investigational Site 5340

    Warsaw, 00-909

  • Teva Investigational Site 5341

    Warsaw, 02-097

  • Teva Investigational Site 5336

    Warsaw, 02-957

  • Teva Investigational Site 5335

    Wroclaw, 50-556

Other trials in Poland

Bulgaria17 sites

  • Teva Investigational Site 5914

    Pleven, 5800

  • Teva Investigational Site 5915

    Pleven, 5800

  • Teva Investigational Site 5917

    Plovdiv, 4000

  • Teva Investigational Site 4212

    Rousse, 7000

  • Teva Investigational Site 5916

    Shumen, 9700

  • Teva Investigational Site 5920

    Sofia, 1000

  • Teva Investigational Site 5907

    Sofia, 1113

  • Teva Investigational Site 5910

    Sofia, 1113

  • Teva Investigational Site 5909

    Sofia, 1309

  • Teva Investigational Site 5919

    Sofia, 1407

  • Teva Investigational Site 5906

    Sofia, 1606

  • Teva Investigational Site 5908

    Sofia, 1606

  • Teva Investigational Site 5911

    Sofia, 1606

  • Teva Investigational Site 5912

    Sofia, 1606

  • Teva Investigational Site 5918

    Stara Zagora, 6000

  • Teva Investigational Site 5913

    Varna, 9010

  • Teva Investigational Site 4211

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Ukraine15 sites

  • Teva Investigational Site 6503

    Chernihiv, 14029

  • Teva Investigational Site 5823

    Chernivtsi, 58018

  • Teva Investigational Site 5811

    Dnipropetrovsk, 49027

  • Teva Investigational Site 5812

    Donetsk, 83003

  • Teva Investigational Site 5814

    Ivano-Frankivsk, 76008

  • Teva Investigational Site 5817

    Kharkiv, 61018

  • Teva Investigational Site 5818

    Kharkiv, 61068

  • Teva Investigational Site 5815

    Kharkiv, 61103

  • Teva Investigational Site 5822

    Kyiv, 03110

  • Teva Investigational Site 5809

    Lviv, 79010

  • Teva Investigational Site 5820

    Odesa, 65025

  • Teva Investigational Site 5821

    Poltava, 36024

  • Teva Investigational Site 5810

    Vinnytsia, 21005

  • Teva Investigational Site 5819

    Zaporizhzhya, 69035

  • Teva Investigational Site 5816

    Zaporizhzhya, 69600

Other trials in Ukraine

Italy12 sites

  • Teva Investigational Site 3056

    Bologna, 40139

  • Teva Investigational Site 3062

    Catania, 95122

  • Teva Investigational Site 3053

    Cefalù, 90015

  • Teva Investigational Site 3054

    Chieti, 66100

  • Teva Investigational Site 3061

    Empoli, 50053

  • Teva Investigational Site 3049

    Florence, 50139

  • Teva Investigational Site 3055

    Naples, 80131

  • Teva Investigational Site 3048

    Rome, 00133

  • Teva Investigational Site 3052

    Rome, 00149

  • Teva Investigational Site 3050

    Rome, 00168

  • Teva Investigational Site 3060

    Rome, 163

  • Teva Investigational Site 3051

    Torino, 10126

Other trials in Italy

Russia11 sites

  • Teva Investigational Site 5043

    Barnaul, 656024

  • Teva Investigational Site 5033

    Moscow, 117152

  • Teva Investigational Site 5032

    Moscow, 117997

  • Teva Investigational Site 5041

    Moscow, 125367

  • Teva Investigational Site 5038

    Novosibirsk, 630087

  • Teva Investigational Site 5042

    Novosibirsk, 630117

  • Teva Investigational Site 5036

    Saint Petersburg, 194291

  • Teva Investigational Site 5035

    Saint Petersburg, 197022

  • Teva Investigational Site 5034

    Saint Petersburg, 197376

  • Teva Investigational Site 5037

    Samara, 443095

  • Teva Investigational Site 5044

    Ufa, 450007

Other trials in Russia

Germany8 sites

  • Teva Investigational Site 6701

    Bayreuth, 95445

  • Teva Investigational Site 6703

    Berlin, 10117

  • Teva Investigational Site 6402

    Berlin, 12203

  • Teva Investigational Site 6700

    Berlin, 13088

  • Teva Investigational Site 6702

    Dresden, 01307

  • Teva Investigational Site 6401

    Hanover, 30559

  • Teva Investigational Site 6403

    Münster, 48149

  • Teva Investigational Site 6400

    Ulm, 89081

Other trials in Germany

Romania8 sites

  • Teva Investigational Site 5218

    Bucharest, 010825

  • Teva Investigational Site 5214

    Bucharest, 022328

  • Teva Investigational Site 5213

    Bucharest, 050098

  • Teva Investigational Site 5215

    Cluj-Napoca, 400012

  • Teva Investigational Site 5217

    Constanța, 900591

  • Teva Investigational Site 8209

    Craiova, 200515

  • Teva Investigational Site 5216

    Iași, 700661

  • Teva Investigational Site 5219

    Sibiu, 550245

Other trials in Romania

South Africa7 sites

  • Teva Investigational Site 9007

    Bloemfontein, 9301

  • Teva Investigational Site 9001

    Cape Town, 7925

  • Teva Investigational Site 9004

    Johannesburg, 2157

  • Teva Investigational Site 9003

    Johannesburg, 2193

  • Teva Investigational Site 9008

    Pietermaritzburg, 3201

  • Teva Investigational Site 9005

    Pretoria, 0041

  • Teva Investigational Site 9006

    Rosebank, 2196

Other trials in South Africa

Spain7 sites

  • Teva Investigational Site 3147

    Barcelona, 08035

  • Teva Investigational Site 3154

    Figueres-Girona, 17600

  • Teva Investigational Site 3149

    L'Hospitalet de Llobregat, 08907

  • Teva Investigational Site 3152

    Madrid, 28041

  • Teva Investigational Site 3151

    Málaga, 29010

  • Teva Investigational Site 3148

    Seville, 41009

  • Teva Investigational Site 3153

    Tortosa-Tarragona, 43500

Other trials in Spain

Croatia6 sites

  • Teva Investigational Site 6003

    Osijek, 31 000

  • Teva Investigational Site 6004

    Split, 21000

  • Teva Investigational Site 6005

    Varaždin, 42000

  • Teva Investigational Site 6001

    Zagreb, 10000

  • Teva Investigational Site 6002

    Zagreb, 10000

  • Teva Investigational Site 6006

    Zagreb, 10000

Other trials in Croatia

Czechia5 sites

  • Teva Investigational Site 5422

    Brno, 602 00

  • Teva Investigational Site 5419

    Olomouc, 779 00

  • Teva Investigational Site 5418

    Prague, 128 08

  • Teva Investigational Site 5420

    Praha 5- Motol, 150 06

  • Teva Investigational Site 5421

    Teplice, 415 29

Other trials in Czechia

Israel4 sites

  • Teva Investigational Site 8043

    Haifa, 3436212

  • Teva Investigational Site 8041

    Jerusalem, 9112001

  • Teva Investigational Site 8040

    Ramat Gan, 5262160

  • Teva Investigational Site 8042

    Ramat Gan, 5262160

Other trials in Israel

Slovakia4 sites

  • Teva Investigational Site 6200

    Bratislava, 813 69

  • Teva Investigational Site 6201

    Bratislava, 826 06

  • Teva Investigational Site 6202

    Nitra, 949 01

  • Teva Investigational Site 6203

    Žilina, 010 01

Other trials in Slovakia

Estonia3 sites

  • Teva Investigational Site 5508

    Kohtla-Järve, 31025

  • Teva Investigational Site 5507

    Tallinn, EE-10617

  • Teva Investigational Site 5509

    Tartu, EE-51014

Other trials in Estonia

Georgia3 sites

  • Teva Investigational Site 8102

    Tbilisi, 0112

  • Teva Investigational Site 8104

    Tbilisi, 0112

  • Teva Investigational Site 8103

    Tbilisi, 0179

Other trials in Georgia

North Macedonia3 sites

  • Teva Investigational Site 6502

    Bitola, 7000

  • Teva Investigational Site 6500

    Skopje, 1000

  • Teva Investigational Site 6501

    Skopje, 1000

Other trials in North Macedonia

Lithuania2 sites

  • Teva Investigational Site 5708

    Kaunas, 50009

  • Teva Investigational Site 5707

    Šiauliai, 76231

Other trials in Lithuania

Puerto Rico1 site

  • Teva Investigational Site 1243

    Guaynabo, 00969

Other trials in Puerto Rico

About this study

Official title: A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon β-1a (Avonex®) in a Rater-blinded Design

The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).

Being tested
Laquinimod, Placebo, Avonex®
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaquinimodDrug

    Laquinimod will be administered per dose and schedule specified in the arm description.

  • PlaceboDrug

    Placebo matching to laquinimod will be administered per schedule specified in the arm description.

  • Avonex®Drug

    Also called Interferon β-1a

    Avonex® will be administered per dose and schedule specified in the arm description.

Study groups in NCT00605215
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive 1 capsule of placebo matching to laquinimod orally once daily for 24 months.
Receives: Drug: Placebo
LaquinimodExperimentalParticipants will receive 1 capsule of laquinimod 0.6 mg orally once daily for 24 months.
Receives: Drug: Laquinimod
Avonex®Active comparatorParticipants will receive an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once weekly for 24 months.
Receives: Drug: Avonex®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Rate of Confirmed Relapses

    A relapse was defined as the appearance of new neurological abnormalities or the reappearance of previously observed neurological abnormalities; lasting at least 48 hours and immediately preceded by an improved neurological state of ≥30 days from onset of previous relapse, accompanied by observed objective neurological changes (an increase of ≥0.5 in Expanded Disability Status Scale [EDSS] score, or an increase of 1 grade in the score of 2 or more of the 7 Functional Systems [FS], or an increase of 2 grades in the score of 1 FS as compared to the previous evaluation). Total number of confirmed relapses during the treatment period was divided by the sum of number of days on study in the treatment period and then multiplied by the number of days in the year to calculate the annualized relapse rate. Annualized relapse rate was derived from a baseline-adjusted negative binomial regression.

    Measured: Baseline up to Month 24

Secondary outcomes (3)

  1. Change From Baseline in Disability as Assessed by the Multiple Sclerosis Functional Composite (MSFC) Score

    The Multiple Sclerosis Functional Composite is an instrument assessing disability that consists of 3 clinical assessments. The 3 are Timed 25-Foot Walk, 9-Hole Peg Test which measures upper extremity (arm and hand) function, and PASAT (Paced Auditory Serial Addition Test) which is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. A Z-score is used to define a common metric from the 3 assessments that constitute the MSFC score. The study's population at baseline was used as reference population for the Z-score calculation. A Z-score of 0 represents the population mean at baseline. Higher Z-scores correspond to an improved outcome.

    Measured: Baseline, Month 24

  2. Percent Change From Baseline in Brain Volume

    Change in brain volume was derived from MRI scans obtained at baseline and at Month 24.

    Measured: Baseline, Month 24

  3. Accumulation of Physical Disability Measured by the Number of Participants With Confirmed Progression of EDSS

    A confirmed progression of EDSS was defined as a 1 point increase from baseline on EDSS score if baseline EDSS was between 0 and 5.0, or a 0.5 point increase if baseline EDSS was 5.5, confirmed 3 months later. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of confirmed progression (number of participants with confirmed progression of EDSS) sustained for 3 months. Progression could not be confirmed during a relapse.

    Measured: Baseline up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2008 (estimated)
  2. Study start24 Apr 2008
  3. Primary completion10 Jun 2011
  4. Study completion10 Jun 2011

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605215
Sponsor's protocol ID
MS-LAQ-302
Other IDs
2007-005450-23
Acronym
BRAVO
Status last verified
Mar 2022
First submitted
8 Jan 2008
Last updated
21 Apr 2022
Data monitoring committee
Yes

Publications

  • Falet JR, Durso-Finley J, Nichyporuk B, Schroeter J, Bovis F, Sormani MP, Precup D, Arbel T, Arnold DL. Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning. Nat Commun. 2022 Sep 26;13(1):5645. doi: 10.1038/s41467-022-33269-x.

    PubMed 36163349

  • Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun.

    PubMed 26000222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laquinimod and Avonex® in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 170 sites in 19 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 11 inclusion and 41 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Poland, Bulgaria, Ukraine, Italy and 14 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 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 21 Apr 2022). 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?

Annualized Rate of Confirmed Relapses (time frame: Baseline up to Month 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 NCT00605215, which also lists 2 linked publications.

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 21 Apr 2022.

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