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A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

Sponsor
Cephalon (Industry)
Overall Status
Terminated
CT.gov ID
NCT01240694
Collaborator
(none)
136
Enrollment
85
Locations
1
Arm
21
Duration (Months)
1.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (sc) CEP 33457 for injection every 4 weeks over 72 weeks (18 doses) in patients with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP 33457, and completed at least visit 8 (week 24 of that study).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
136 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: CEP-33457

200 mcg of CEP-33457

Drug: Lupuzor
200 mcg
Other Names:
  • CEP-33457

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the long term safety and tolerability of repeated administration of subcutaneous (sc) CEP-33457 in patients with systemic lupus erythematosus (SLE) [each 4 week interval up to a total duration of 72 weeks]

      Overall Safety will be assessed by evaluating the following: occurrence of adverse events clinical laboratory tests vital signs measurements physical examination findings concomitant medication usage

    Secondary Outcome Measures

    1. Proportion of patients achieving a clinical response using the SLE responder index (SRI) at each visit during the treatment period [at each 4 week interval up to Week 72]

      An SRI response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no British Isles Lupus Assessment Group A (BILAG A) organ domain score, and no more than 1 new BILAG B organ domain score from baseline.

    2. Assessment of disease activity according to the change in the SLEDAI-2K score at each visit during the treatment period [at each 4 week interval up to Week 72]

      SLEDAI-2K = Systemic Lupus Erythematosus Disease Activity Index 2000. It is a global index and includes 24 weighted clinical and laboratory variables.

    3. Measure of disease activity based upon the physician intention to treat according to the change in the BILAG-2004 score at each visit during the treatment period [at each 4 week interval up to Week 72]

      BILAG-2004 = British Isles Lupus Assessment Group 2004. BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems.

    4. The effect of CEP-33457 on the status of disease (PhGA scale) at each visit during the treatment period [at each 4 week interval up to Week 72]

    5. The effect of CEP-33457 on the status of disease (Patient's Global Assessment [PtGA] scale) [at weeks 12, 24, 36, 48 and 60 and the final assessment (or early termination)]

    6. The effect of CEP-33457 on health related quality of life, as assessed by completion of the Medical Outcome Survey Short Form 36 (SF 36) [at weeks 12, 24, 36, 48 and 60 and the final assessment (or early termination)]

    7. The effect of CEP-33457 on biologic markers of disease activity during the study [At weeks 12, 24, 36, 48, 60, and the final assessment (or early termination)]

      Biological markers- anti-U1 ribonucleoprotein antibody (anti U1RNP Ab) anti-Smith antibody (anti Sm Ab) C-reactive protein (CRP) immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin E (IgE) antinuclear antibody (ANA)

    8. The effect of CEP-33457 on the incidence of disease flares, eg, Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index [at each 4 week interval up to Week 72]

    9. The effect of CEP-33457 on the occurrence of systemic lupus erythematosus-induced (SLE-induced) organ damage [at weeks 24, 48, and the final assessment (or early termination)]

      e.g., Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index

    10. Remission of disease [during the overall 72 week study period]

      (i.e., reduction of SLEDAI-2K score to 0)

    11. Proportion of patients with changes in steroid dose over time throughout the study [during the overall 72 week study period]

    12. Presence of anti-CEP-33457 antibodies [at weeks 24, 48, and final assessment (or early termination)]

      This is an assessment of the immunogenicity of CEP-33457

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The patient has an established diagnosis of systemic lupus erythematosus (SLE) as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.

    • The patient previously participated in and completed at least visit 8 (week 24) the Cephalon sponsored clinical study with CEP 33457 (study C33457/2047) and, in the investigator's opinion, would benefit from continued participation in a clinical study.

    • Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment.

    Exclusion Criteria:

    • The patient has New York Heart Association (NYHA) Class III or IV congestive heart failure.

    • The patient has an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 (via Modification of Diet in Renal Disease [MDRD] equation).

    • The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin level greater than 1.5 times ULN.

    • The patient has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the first dose of study drug and for 3 months after administration of the last dose of study drug.

    • The patient has any clinically significant abnormalities on ECG that are not related to SLE, as determined by the investigator. Patients with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.

    • The patient has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the first dose of study drug. Less severe infections in the 3 months prior to administration of the first dose of study drug are permitted at the discretion of the investigator and medical monitor.

    • The patient has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator.

    • The patient has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).

    • The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease.

    • The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit for study C33457/2047, or has current substance abuse.

    • The patient has a history of severe allergic reactions to or hypersensitivity to any component of the study drug.

    • The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)

    • The patient has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 30 days prior to the 1st dose of study drug, except for treatment with CEP-33457 or placebo in study C33457/2047.

    • The patient has a known history of antibodies to CEP-33457.

    • The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States
    2 University of Arizona Tucson Arizona United States
    3 University of California, Los Angeles Los Angeles California United States
    4 Wallace Rheumatic Study Center Los Angeles California United States
    5 UCSD VA San Diego Healthcare System San Diego California United States
    6 East Bay Rheumatology San Leandro California United States
    7 Stanford University Medical Center Stanford California United States
    8 University of Colorado Boulder Colorado United States
    9 Arthritis and Rheumatic Disease Specialties Aventura Florida United States
    10 Clincial Research of West Florida, Inc. Clearwater Florida United States
    11 Centre for Rheumatology, Immunology and Arthritis Research Fort Lauderdale Florida United States
    12 Science and Research Institute, Inc Jupiter Florida United States
    13 Tampa Medical Group, Pa Tampa Florida United States
    14 Atlanta Center for Clinical Research Atlanta Georgia United States
    15 Emory University Atlanta Georgia United States
    16 Arthritis Research and Treatment Center Stockbridge Georgia United States
    17 Coeur D'Alene Arthritis Clinic Coeur d'Alene Idaho United States
    18 Bluegrass Clinical Research, Inc. Lexington Kentucky United States
    19 Johns Hopkins University Medical Center Baltimore Maryland United States
    20 Tufts New England Medical Center Boston Massachusetts United States
    21 University of Michigan Medical Center Ann Arbor Michigan United States
    22 Feinstein Institute for Medical Research Manhasset New York United States
    23 University of North Carolina Hospitals Chapel Hill North Carolina United States
    24 Box Arthritis and Rheumatology of the Carolinas PLLC Charlotte North Carolina United States
    25 Duke University Medical Center Durham North Carolina United States
    26 Carolina Bone and Joint Monroe North Carolina United States
    27 SSM Healthcare of Oklahoma, Inc. Oklahoma City Oklahoma United States
    28 Altoona Center for Clinical Research Duncansville Pennsylvania United States
    29 Allegheny Singer Research Institute Pittsburgh Pennsylvania United States
    30 Medical University of South Carolina Charleston South Carolina United States
    31 Metroplex Clinical Research Center Dallas Texas United States
    32 Accurate Clinical Research Houston Texas United States
    33 Houston Institute For Clinical Research Houston Texas United States
    34 Southwest Rhuematology, PA Mesquite Texas United States
    35 Arthritis Associates Research, LLC San Antonio Texas United States
    36 Scott - White Clinic/Texas A and M University Temple Texas United States
    37 Arthritis Clinic Of Northern Va, P.C. Arlington Virginia United States
    38 Seattle Rheumatology Associates Seattle Washington United States
    39 Medical College of Wisconsin Milwaukee Wisconsin United States
    40 UZ Brussel Brussel Belgium
    41 CHU de Liège Liège Belgium
    42 Cliniques Universitaires UCL de Mont-Godinne Yvoir Belgium
    43 Revmatologie s.r.o. Brno Czechia
    44 Fakultni nemocnice Plzen - Bory Czechia
    45 Revmatologicky ustav Praha 2 Czechia
    46 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia
    47 Hôpital Claude Huriez Lille France
    48 CHU de Nantes - Hotel Dieu Nantes France
    49 Groupe Hospitalier Pitié- Salpétrière Paris France
    50 Hôpital Cochin Paris France
    51 Hôpital de Hautepierre Strasbourg France
    52 University Clinics Aachen Aachen Germany
    53 Charité - Universitätsmedizin Berlin Berlin Germany
    54 Universitatsklinikum Carl Gustav Carus Dresden Germany
    55 Universitätsklinikum Düsseldorf Düsseldorf Germany
    56 Klinikum Eilbek Hamburg Germany
    57 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Germany
    58 LMU Klinikum der Universität München Germany
    59 Országos Reumatológiai és Fizioterápiás Intézet Budapest Hungary
    60 Debreceni Egyetem Orvos- és Egészségtudományi Centrum Debrecen Hungary
    61 Zala Megyei Kórház Zalaegerszeg Hungary
    62 Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Unica Dabrowka Poland
    63 Wojewodzki Szpital Zespolony Elblag Poland
    64 Zespol Opieki Zdrowotnej w Konskich Konskie Poland
    65 Niepubliczny Zaklad Opieki Zdrowotnej Lublin Poland
    66 Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin Poland
    67 Linea Corporis- Chirurgia Plastyczna Warszawa Poland
    68 Akademicki Szpital Kliniczny we Wroclawiu im. Jana Mikulicza Wroclaw Poland
    69 Hospital Fernando Fonseca Amadora Portugal
    70 Hospitais da Universidade de Coimbra Coimbra Portugal
    71 Hospital de São João Porto Portugal
    72 Hospital Geral de Santo Antonio Porto Portugal
    73 Hospital Virgen del Rocio Sevilla Andalucía Spain
    74 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain
    75 Hospital Vall D´Hebron Barcelona Cataluña Spain
    76 Regional Clinical Hospital for Professional Diseases Donetsk Ukraine
    77 Ivano-Frankivsk Regional Clinical Hospital Ivano-Frankivsk Ukraine
    78 Institute of Cardiology named after Strazhesko Kyiv Ukraine
    79 Kyiv Regional Clinical Hospital Kyiv Ukraine
    80 Olexandrivska Clinical Hospital Kyiv Ukraine
    81 Lviv Regional Pediatric Hospital Lviv Ukraine
    82 Royal National Hospital for Rheumatic Diseases Bath United Kingdom
    83 Chapel Allerton Hospital Leeds United Kingdom
    84 St. Thomas Hospital London United Kingdom
    85 Freeman Hospital Newcastle Upon Tyne United Kingdom

    Sponsors and Collaborators

    • Cephalon

    Investigators

    • Study Director: Sponsor's Medical Expert, Cephalon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cephalon
    ClinicalTrials.gov Identifier:
    NCT01240694
    Other Study ID Numbers:
    • C33457/3075
    First Posted:
    Nov 15, 2010
    Last Update Posted:
    Sep 10, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Cephalon
    Lupus
    SLE
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic

    Study Results

    No Results Posted as of Sep 10, 2018