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AzTrials

Eosinophilic AsthmaPhase 3NCT01290887

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

A Phase 3 study testing Reslizumab in people with Eosinophilic Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 219 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant… Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Eosinophilic Asthma
What is being tested?
Reslizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,052 participants
Where
219 sitesin 31 countries
Study dates
Jun 2011to Jan 2015
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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Written informed consent is obtained.
  • Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
  • other criteria may apply; please contact the investigator for more information.

Who cannot join

  • The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
  • The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
  • The patient is a current smoker.
  • The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
  • The patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [GERD]).
  • Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
  • The patient has a current infection or disease that may preclude assessment of asthma.
  • other criteria may apply; please contact the investigator for more information.

Trial locations and contacts

219 sites in 31 countries.

219 sites in 31 countries

United States48 sites

  • Teva Investigational Site 66

    Altoona, Pennsylvania

  • Teva Investigational Site 12

    Anaheim, California

  • Teva Investigational Site 46

    Bangor, Maine

  • Teva Investigational Site 63

    Boerne, Texas

  • Teva Investigational Site 64

    Boys Town, Nebraska

  • Teva Investigational Site 21

    Charleston, South Carolina

  • Teva Investigational Site 20

    Cincinnati, Ohio

  • Teva Investigational Site 31

    Cincinnati, Ohio

  • Teva Investigational Site 53

    Clearwater, Florida

  • Teva Investigational Site 2

    Colorado Springs, Colorado

  • Teva Investigational Site 34

    Colorado Springs, Colorado

  • Teva Investigational Site 44

    Dallas, Texas

  • Teva Investigational Site 47

    Denver, Colorado

  • Teva Investigational Site 69

    El Paso, Texas

  • Teva Investigational Site 16

    Fort Worth, Texas

  • Teva Investigational Site 11

    Fountain Valley, California

  • Teva Investigational Site 41

    Fresno, California

  • Teva Investigational Site 24

    Largo, Florida

  • Teva Investigational Site 25

    Lawrenceville, Georgia

  • Teva Investigational Site 49

    Lexington, Kentucky

  • Teva Investigational Site 6

    Lilburn, Georgia

  • Teva Investigational Site 73

    Lincoln, Rhode Island

  • Teva Investigational Site 59

    Long Beach, California

  • Teva Investigational Site 43

    Los Angeles, California

  • Teva Investigational Site 33

    Madison, Wisconsin

  • Teva Investigational Site 1

    Medford, Oregon

  • Teva Investigational Site 27

    Miami, Florida

  • Teva Investigational Site 55

    Miami, Florida

  • Teva Investigational Site 5

    Miami, Florida

  • Teva Investigational Site 32

    Nashville, Tennessee

  • Teva Investigational Site 50

    Oklahoma City, Oklahoma

  • Teva Investigational Site 8

    Omaha, Nebraska

  • Teva Investigational Site 4

    Orange, California

  • Teva Investigational Site 52

    Orlando, Florida

  • Teva Investigational Site 9

    Providence, Rhode Island

  • Teva Investigational Site 14

    San Antonio, Texas

  • Teva Investigational Site 45

    San Antonio, Texas

  • Teva Investigational Site 3

    Savannah, Georgia

  • Teva Investigational Site 58

    Scottsdale, Arizona

  • Teva Investigational Site 40

    St Louis, Missouri

  • Teva Investigational Site 74

    St Louis, Missouri

  • Teva Investigational Site 26

    Summit, New Jersey

  • Teva Investigational Site 19

    Tallahassee, Florida

  • Teva Investigational Site 17

    Trinity, Florida

  • Teva Investigational Site 18

    Valrico, Florida

  • Teva Investigational Site 15

    Walnut Creek, California

  • Teva Investigational Site 28

    Waterbury, Connecticut

  • Teva Investigational Site 30

    Winston-Salem, North Carolina

Other trials in United States

Russia14 sites

  • Teva Investigational Site 545

    Barnaul

  • Teva Investigational Site 549

    Kemerovo

  • Teva Investigational Site 543

    Moscow

  • Teva Investigational Site 544

    Moscow

  • Teva Investigational Site 554

    Moscow

  • Teva Investigational Site 558

    Moscow

  • Teva Investigational Site 559

    Moscow

  • Teva Investigational Site 555

    Novosibirsk

  • Teva Investigational Site 557

    Novosibirsk

  • Teva Investigational Site 540

    Saint Petersburg

  • Teva Investigational Site 541

    Saint Petersburg

  • Teva Investigational Site 542

    Saint Petersburg

  • Teva Investigational Site 552

    Tomsk

  • Teva Investigational Site 546

    Yaroslavl

Other trials in Russia

Ukraine12 sites

  • Teva Investigational Site 621

    Dnipropetrovsk

  • Teva Investigational Site 629

    Donetsk

  • Teva Investigational Site 630

    Ivano-Frankivsk

  • Teva Investigational Site 620

    Kharkiv

  • Teva Investigational Site 633

    Kharkiv

  • Teva Investigational Site 622

    Kyiv

  • Teva Investigational Site 623

    Kyiv

  • Teva Investigational Site 624

    Kyiv

  • Teva Investigational Site 625

    Kyiv

  • Teva Investigational Site 626

    Vinnytsia

  • Teva Investigational Site 631

    Zaporizhzhya

  • Teva Investigational Site 632

    Zaporizhzhya

Other trials in Ukraine

Israel9 sites

  • Teva Investigational Site 423

    Ashkelon

  • Teva Investigational Site 432

    Haifa

  • Teva Investigational Site 425

    Jerusalem

  • Teva Investigational Site 428

    Jerusalem

  • Teva Investigational Site 426

    Kfar Saba

  • Teva Investigational Site 422

    Petah Tikva

  • Teva Investigational Site 433

    Ramat Gan

  • Teva Investigational Site 421

    Rehovot

  • Teva Investigational Site 420

    Tel Aviv

Other trials in Israel

South Africa9 sites

  • Teva Investigational Site 584

    Cape Town

  • Teva Investigational Site 586

    Cape Town

  • Teva Investigational Site 587

    Centurion

  • Teva Investigational Site 582

    Durban

  • Teva Investigational Site 585

    Durban

  • Teva Investigational Site 580

    Johannesburg

  • Teva Investigational Site 589

    Johannesburg

  • Teva Investigational Site 583

    Pretoria

  • Teva Investigational Site 588

    Pretoria

Other trials in South Africa

Argentina8 sites

  • Teva Investigational Site 121

    Ciudad Autonoma de Buenos Aire

  • Teva Investigational Site 126

    Ciudad Autonoma de Buenos Aire

  • Teva Investigational Site 127

    Ciudad Autonoma de Buenos Aire

  • Teva Investigational Site 128

    Quilmes-Buenos Aires

  • Teva Investigational Site 125

    Rosario

  • Teva Investigational Site 123

    Rosario-Santa Fe

  • Teva Investigational Site 120

    San Miguel de Tucuman - Tucuma

  • Teva Investigational Site 122

    San Miguel de Tucuman - Tucuma

Other trials in Argentina

Germany8 sites

  • Teva Investigational Site 361

    Berlin

  • Teva Investigational Site 366

    Berlin

  • Teva Investigational Site 371

    Bochum

  • Teva Investigational Site 369

    Frankfurt

  • Teva Investigational Site 370

    Hamburg

  • Teva Investigational Site 372

    Koblenz

  • Teva Investigational Site 367

    Leipzig

  • Teva Investigational Site 363

    Mainz

Other trials in Germany

Peru8 sites

  • Teva Investigational Site 223

    Cercado de Lima, Lima

  • Teva Investigational Site 220

    Lima

  • Teva Investigational Site 221

    Lima

  • Teva Investigational Site 222

    Lima

  • Teva Investigational Site 225

    Lima

  • Teva Investigational Site 226

    Lima

  • Teva Investigational Site 227

    Lima

  • Teva Investigational Site 229

    Lima

Other trials in Peru

Poland8 sites

  • Teva Investigational Site 507

    Bialystok

  • Teva Investigational Site 509

    Bydgoszcz

  • Teva Investigational Site 513

    Gdansk

  • Teva Investigational Site 512

    Lodz

  • Teva Investigational Site 505

    Lublin

  • Teva Investigational Site 500

    Ostrów Wielkopolski

  • Teva Investigational Site 511

    Poznan

  • Teva Investigational Site 504

    Tarnów

Other trials in Poland

Brazil7 sites

  • Teva Investigational Site 146

    Belo Horizonte

  • Teva Investigational Site 150

    Florianópolis

  • Teva Investigational Site 140

    Porto Alegre

  • Teva Investigational Site 144

    Porto Alegre

  • Teva Investigational Site 147

    Porto Alegre - RS

  • Teva Investigational Site 143

    Porto Alegre, RS

  • Teva Investigational Site 142

    Santo André

Other trials in Brazil

Czechia7 sites

  • Teva Investigational Site 284

    Břeclav

  • Teva Investigational Site 287

    Brno

  • Teva Investigational Site 286

    Liberec

  • Teva Investigational Site 280

    Olomouc

  • Teva Investigational Site 281

    Olomouc

  • Teva Investigational Site 285

    Olomouc

  • Teva Investigational Site 283

    Tábor

Other trials in Czechia

Hungary7 sites

  • Teva Investigational Site 401

    Balassagyarmat

  • Teva Investigational Site 400

    Miskolc

  • Teva Investigational Site 404

    Mosonmagyaróvár

  • Teva Investigational Site 403

    Sopron

  • Teva Investigational Site 407

    Százhalombatta

  • Teva Investigational Site 402

    Tatabánya

  • Teva Investigational Site 405

    Törökbálint

Other trials in Hungary

Mexico7 sites

  • Teva Investigational Site 203

    Distrito Federal

  • Teva Investigational Site 204

    Guadalajara, JAL

  • Teva Investigational Site 200

    Hermosillo, Sonora

  • Teva Investigational Site 205

    Mexico City

  • Teva Investigational Site 207

    Mexico City

  • Teva Investigational Site 209

    Monterrey

  • Teva Investigational Site 202

    Tijuana, B.C.

Other trials in Mexico

South Korea6 sites

  • Teva Investigational Site 682

    Gwangju

  • Teva Investigational Site 680

    Seoul

  • Teva Investigational Site 681

    Seoul

  • Teva Investigational Site 683

    Seoul

  • Teva Investigational Site 686

    Seoul

  • Teva Investigational Site 685

    Suwon

Other trials in South Korea

Belgium5 sites

  • Teva Investigational Site 261

    Brussels

  • Teva Investigational Site 264

    Brussels

  • Teva Investigational Site 260

    Ghent

  • Teva Investigational Site 262

    Jambes

  • Teva Investigational Site 263

    Liège

Other trials in Belgium

Chile5 sites

  • Teva Investigational Site 160

    Rancagua

  • Teva Investigational Site 164

    Santiago

  • Teva Investigational Site 161

    Temuco

  • Teva Investigational Site 162

    Valdivia

  • Teva Investigational Site 166

    Valparaíso

Other trials in Chile

Malaysia5 sites

  • Teva Investigational Site 705

    Batu Caves

  • Teva Investigational Site 701

    George Town

  • Teva Investigational Site 700

    Kuala Lumpur

  • Teva Investigational Site 702

    Kuala Lumpur

  • Teva Investigational Site 704

    Taiping

Other trials in Malaysia

New Zealand5 sites

  • Teva Investigational Site 723

    Auckland

  • Teva Investigational Site 724

    Dunedin

  • Teva Investigational Site 727

    Hamilton

  • Teva Investigational Site 720

    Tauranga

  • Teva Investigational Site 721

    Wellington

Other trials in New Zealand

Philippines5 sites

  • Teva Investigational Site 742

    Manila

  • Teva Investigational Site 740

    Quezon City

  • Teva Investigational Site 741

    Quezon City

  • Teva Investigational Site 743

    Quezon City

  • Teva Investigational Site 745

    Quezon City

Other trials in Philippines

Romania5 sites

  • Teva Investigational Site 523

    Bucharest

  • Teva Investigational Site 524

    Bucharest

  • Teva Investigational Site 520

    Cluj-Napoca

  • Teva Investigational Site 521

    Iași

  • Teva Investigational Site 522

    Târgu Mureş

Other trials in Romania

Sweden5 sites

  • Teva Investigational Site 602

    Gothenburg

  • Teva Investigational Site 604

    Gothenburg

  • Teva Investigational Site 603

    Linköping

  • Teva Investigational Site 600

    Lund

  • Teva Investigational Site 601

    Malmö

Other trials in Sweden

Australia4 sites

  • Teva Investigational Site 641

    East Bentleigh

  • Teva Investigational Site 642

    Frankston

  • Teva Investigational Site 645

    Liverpool

  • Teva Investigational Site 643

    Nedlands

Other trials in Australia

Canada4 sites

  • Teva Investigational Site 103

    Calgary

  • Teva Investigational Site 101

    Montreal

  • Teva Investigational Site 104

    Newmarket

  • Teva Investigational Site 105

    Windsor

Other trials in Canada

Colombia4 sites

  • Teva Investigational Site 181

    Bogotá

  • Teva Investigational Site 185

    Bogotá

  • Teva Investigational Site 182

    Cali

  • Teva Investigational Site 180

    Floridablanca

Other trials in Colombia

Slovakia4 sites

  • Teva Investigational Site 563

    Bradejov

  • Teva Investigational Site 561

    Levice

  • Teva Investigational Site 560

    Spišská Nová Ves

  • Teva Investigational Site 562

    Topoľčany

Other trials in Slovakia

Thailand3 sites

  • Teva Investigational Site 780

    Bangkok

  • Teva Investigational Site 782

    Bangkok

  • Teva Investigational Site 784

    Nakhon Ratchasima

Other trials in Thailand

France2 sites

  • Teva Investigational Site 342

    Marseille

  • Teva Investigational Site 341

    Montpellier

Other trials in France

Taiwan2 sites

  • Teva Investigational Site 761

    Taipei

  • Teva Investigational Site 763

    Taoyuan

Other trials in Taiwan

Denmark1 site

  • Teva Investigational Site 300

    Odense

Other trials in Denmark

Greece1 site

  • Teva Investigational Site 380

    Athens

Other trials in Greece

Netherlands1 site

  • Teva Investigational Site 460

    Heerlen

Other trials in Netherlands

About this study

Official title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

Read the detailed description

Study patients deemed eligible based on activities from the preceding Teva sponsored double blind study of reslizumab in eosinophilic asthma. Specifically, as per inclusion criterion c, patients must have either completed treatment in a previous Teva-sponsored study or have received at least 2 doses of study drug treatment in a pulmonary function study.

Eligible patients could enroll in this study only after completion of the end of treatment visit in a Teva sponsored, randomized, placebo controlled, double blind study of reslizumab in eosinophilic asthma, which served as the screening/baseline visit for participation in this open label extension study. The use of systemic corticosteroids for asthma in any of the previous Teva sponsored double blind studies of reslizumab did not exclude patients from this study. The previous Teva studies were C38072/3081 (NCT01270464), C38072/3082 (NCT01287039), and C38072/3083 (NCT01285323).

Being tested
Reslizumab
Medical subject headings
Pulmonary Eosinophilia

What participants receive

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

  • ReslizumabDrug

    Also called Cinquil, humanized monoclonal antibody, CEP-38072

    Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

Study groups in NCT01290887
Study groupRoleWhat they receive
Reslizumab 3.0 mg/kgExperimentalReslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Receives: Drug: Reslizumab

What is being measured

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

  1. Participants With Treatment-Emergent Adverse Events

    An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.

  2. Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values

    Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.

    Significance criteria:

    • Blood urea nitrogen: >=10.71 mmol/L
    • Creatinine: >=177 μmol/L
    • Uric acid: M>=625, F>=506 μmol/L
    • Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
    • Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
    • GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.
    • Total bilirubin: >=34.2 μmol/L
    • White blood cells- low: <=3.0*10^9/L
    • White blood cells-high: >=20*10^9/L
    • Hemoglobin: M<=115, F<=95 g/dL
    • Hematocrit: M<0.37, F<0.32 L/L
    • Platelets: >=700*10^9/L
    • Absolute neutrophil count: <=1.0*10^9/L
    • Eosinophils: >=10
    • Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline

    Measured: Weeks 4, 8, 24 and 48

  3. Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values

    Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.

    Significance criteria

    • Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)
    • Sitting heart rate-low: <50 and decrease of >=30 beats/min
    • Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)
    • Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)
    • Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)
    • Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)
    • Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)
    • Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)
    • Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)
    • Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)
    • Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)
    • Body temperature-low: <96.5° Fahrenheit (all ages)
    • Body temp-high: >100.5° F (all ages)

    Measured: Week 4 to Week 65

Secondary outcomes (9)

  1. Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  2. Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  3. Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.

    .

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  4. Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second

    .

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  5. Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.

    .

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  6. Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.

    .

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  7. Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

    The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.

    Measured: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

  8. Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint

    The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.

    Measured: Weeks 24, 48, 72, 96, End of Study and Endpoint

  9. Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall

    Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.

    Predose samples for the reslizumab-experienced participants came from the previous studies.

    Measured: Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall

Timeline

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

  1. First posted7 Feb 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJan 2015
  4. Study completionJan 2015

Why it stopped: Business decision

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,052 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01290887
Sponsor's protocol ID
C38072/3085
Other IDs
2010-024540-15
Status last verified
Apr 2016
First submitted
4 Feb 2011
Last updated
6 Jun 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Reslizumab in people with Eosinophilic Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 219 sites in 31 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 8 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: stopped early, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States, Russia, Ukraine, Israel, South Africa and 26 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 6 Jun 2016). 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?

Participants With Treatment-Emergent Adverse Events (time frame: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.). The study lists 3 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 NCT01290887.

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 6 Jun 2016.

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