ASPEN: Study of LJP 394 in Lupus Patients With History of Renal Disease

Sponsor
La Jolla Pharmaceutical Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT00089804
Collaborator
(none)
943
201
3
52
4.7
0.1

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

Condition or Disease Intervention/Treatment Phase
  • Drug: abetimus sodium (LJP 394) and/or placebo solution
  • Drug: abetimus sodium (LJP 394)
  • Drug: Phosphate-buffered saline
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
943 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly

Drug: abetimus sodium (LJP 394) and/or placebo solution
300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks

Active Comparator: 2

900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly

Drug: abetimus sodium (LJP 394)
900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.

Placebo Comparator: 3

A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly

Drug: Phosphate-buffered saline
A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks
Other Names:
  • Placebo, normal saline
  • Outcome Measures

    Primary Outcome Measures

    1. To determine whether abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a history of SLE renal disease. Weekly administration with a 52-week treatment duration. [Time to event (12 months fixed treatment duration)]

    Secondary Outcome Measures

    1. To determine whether treatment with abetimus sodium is more effective than placebo in delaying the time to Major SLE flare; and to determine whether treatment with abetimus sodium (LJP 394) is more effective than placebo in reducing proteinuria. [12 month fixed treatment duration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of Systemic Lupus Erythematosus (SLE)

    • Active SLE renal disease within past 4 years.

    • Males or females between 12 and 70 years old.

    • Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.

    • Ability to have weekly intravenous (IV) administration of study treatment.

    Exclusion Criteria:
    • Active SLE renal disease within past 3 months prior to entering study.

    • Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.

    • Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.

    • Use of rituximab within 6 months prior to entering study.

    • Current abuse of drugs or alcohol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Wallace Rheumatic Study Center Los Angeles California United States 90048
    3 East Bay Rheumatology Medical Group San Leandro California United States 94578
    4 Private Practice San Mateo California United States 94401
    5 CRIA Research Fort Lauderdale Florida United States 33334
    6 Miami Children's Hospital Miami Florida United States 33155
    7 Emory University School of Medicine, Renal Division Atlanta Georgia United States 30322
    8 Private Practice Augusta Georgia United States 30909
    9 Southeast Regional Research Group Savannah Georgia United States 31406
    10 Intermountain Orthopedics Boise Idaho United States 83702
    11 Rheumatology Associates Chicago Illinois United States 60612
    12 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    13 SOMARC Trials, LLC Greenbelt Maryland United States 20770
    14 Nephrology Associates, PC Flushing New York United States 11355
    15 North Shore - LIJ Health System Lake Success New York United States 11042
    16 Feinstein Institute for Medical Research Manhasset New York United States 11030
    17 Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases New York New York United States 10003
    18 AAIR Research Center Rochester New York United States 14618
    19 Suny Upstate Medical University Syracuse New York United States 13210
    20 Wake Forest University Health Sciences Winston Salem North Carolina United States 27157
    21 Ohio State University Medical Center Columbus Ohio United States 43210
    22 Healthcare Research Consultants Tulsa Oklahoma United States 74135
    23 Private Practice Camp Hill Pennsylvania United States 17011
    24 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    25 Arthritis Clinic, 371 North Parkway, Suite 400 Jackson Tennessee United States 38305
    26 Amarillo Center for Clinical Research Amarillo Texas United States 79124
    27 Miracle Medical Clinic, 1170 Blalock Road Houston Texas United States 77055
    28 Renal Care Clinic, P.A., 17202 Red Oak Drive Houston Texas United States 77090
    29 Texas Tech University Health Sciences Center Lubbock Texas United States 79430
    30 San Antonio Kidney Disease Center San Antonio Texas United States 78229
    31 Clinical Research & Consulting Center Fairfax Virginia United States 22030
    32 Arthritis Northwest PLLC Spokane Washington United States 99204
    33 CIR Hospital Sirio Libanes. Campana 4658 Buenos Aires Ciudad Autonma de Argentina C1419AHN
    34 Centro de Investigaciones Reumatológicas San Miguel de Tucumán Provincia de Tucumán Argentina 4000
    35 Instituto CAICI Rosario Santa Fe Argentina S2000PBJ
    36 Organización Médica de la Investigación Buenos Aires Uruguay 725 P.B. Argentina C1015ABO
    37 Unidad de Alergia, Asma e Inmunología Clínica Buenos Aires Argentina 1035
    38 Centro de Investigaciones en Enfermedades Reumaticas (CIER) Buenos Aires Argentina C1055AAF
    39 Centro de Investigaciones Reumatologicas y Osteologicas Buenos Aires Argentina C11117ABH
    40 Investigación Clínica Polivalente La Plata Argentina 1902
    41 Rheumatology Clinic Cairns Australia QLD 4870
    42 Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway St Leonards Australia NSW 2065
    43 Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy Victoria Australia 3065 702
    44 Gomel Regional Clinical Hospital Gomel Belarus 246029
    45 Minsk City Clinical Hospital # 2 Minsk Belarus 220020
    46 Minsk City Clinical Hospital # 164 Minsk Belarus 220113
    47 Minsk City Clinical Hospital # 9 Minsk Belarus 220116
    48 Minsk Regional Clinical Hospital Minsk Belarus 223040
    49 Vitebsk Regional Clinical Hospital Vitebsk Belarus 210037
    50 Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul-PUCRS Porto Alegre-RS Av. Ipiranga, 6690-Conj. 220-Jardim Botanico Brazil 90610-000
    51 Hospital Universitario Pedro Ernesto Rio de Janeiro Avenida 28 de Setembro, 77 Brazil 20.551-030
    52 Hospital Hehopolis Sao Paulo Avenida Almirante Delamare, 1534-Sacoman Brazil 04230-000
    53 Hospital Geral de Goiania, GO Av Anhanguera 6479 Setor Oeste Goiania-GO Goias Brazil CEP: 74 110 120
    54 Santa Casa de Misericórdia de BeloHorizonte, Av. Francisco Sales, n. 1111 9 andar Ala D/ CCIH Belo Horizonte Minas Gerais Brazil CEP: 30150 221
    55 Hospital das Clinicas da Faculdade de Medicina da Universidade, Federal de Goiás, Servico de Reumatologia / 2 andar Goiänia, Goiás Primeira Avenida s/n Setor Universitário Brazil 74605-020
    56 Hospital de Clinicas - Universidade Estadual de Campinas - UNICAMP, Rua Vital Brasil, 250 - 3º andar - Cidade Universitária Zeferin Campinas - SP Brazil Cep: 13083-888
    57 Hospital e Maternidade Celso Pierro - PUCCampinas, Av. John Boyd Dunlop, s/n Campinas - Sāo Paulo Brazil 13059-740
    58 Athritis Clinica de Doenças Reumaticas, Av. Padre Anchieta, 1846 cj 1108 Curitiba - PR Brazil 80730-000
    59 Hospital de Clinicas de Porto Alegre - HCPA Porto Alegre-RS Brazil 90035-903
    60 Hospital das Clínicas of Medicine School of University of São Paulo (USP) at Ribeirão Preto Rheumatology Department Avenida dos Ribeirão Preto Brazil Cep: 14048-900
    61 Hospital Santa Izabel, Praca Almeida Couto, 500 - Naxaré Salvador - BA Brazil CEP: 40050 410
    62 Irmandade da Santa Casa de Misericórdia de Sāo Paulo Rua, Dr. Cesário Motta Junior, 112 São Paulo Brazil Cep: 01221-020
    63 Rua Pedro de Toledo 1800 9 andar/ Ala central - Diretoria de Servico de Reumatologia Săo Paulo - SP Brazil CEP: 04039 004
    64 NMTranspH "Tsar Boris Treti", Clinic of Internal Diseases Sofia 104 "Maria Louisa" blvd. Bulgaria 1233
    65 MHAT "Stara Zagora", Second Clinic of Internal Diseases Stara Zagora 11 "Armeiska" street Bulgaria 6000
    66 MHAT "Sveti Ivan Rilski", Clinic of Rheumatology Sofia 13 "Urvich" Street Bulgaria 1612
    67 MHAT "Sveti Georgi", Clinic of Rheumatology Plovdiv 15A "Vasil Aprilov" blvd. Bulgaria 4002
    68 Military Medical Academy, Clinic of Urology and Nephrology Sofia 3, Georgi Sofiiski, str. Bulgaria 1606
    69 Clinic of Nephrology, MHAT "Alexandrovska" 1, Georgi Sofiiski, str., Sofia Bulgaria 1431
    70 Fakultni nemocnice Plzen, Oddeleni klinické farmakologie Plzen Edvarda Benese Czech Republic 13305 99
    71 VFN Prahal Lékarská fakulta, Klinika detského a dorostového lékarstvi, Praha 2 Ke Karlovu, 09 Praha 2, Czech Republic 2121
    72 Revmatologický ústav Praha 2 Czech Republic 128 50
    73 Academic VL Tsitlanadze Scientific - Practical Center of Rheumatology Tbilisi Georgia 0102
    74 Herz and Rheumazentrum Kerckhoff-klinik GmbH Bad Nauheim Benekestrasse 2-8 Germany 61231
    75 Charité-Unversitätmedizin Berlin, CharitéCentrum Inn ere Medizin und Dermatologie Berlin Chariteplatz 1 Germany 10117
    76 Medizinische Klinik und Poliklinik IV des Universitätsklinikum Lepizig, Rheumatologie Leipzig Liebigstrasse 22 Germany 04103
    77 Georg August Universität Göttingen Universitätsklinikum, Zentrum Innere Medizin Göttingen Robert-Kochstr. 40 Germany 37075
    78 Johannes Gutenberg-Universität I. Medizinische Klinik und Poliklinik,Langenbeckstr. 1 Mainz Germany 55131
    79 Hong Kong University, Queen Mary Hospital Hong Kong Hong Kong
    80 The Chinese University of Hong Kong, Prince of Wales Hospital Hong Kong Hong Kong
    81 Szent Margit Hospital, Department of Nephrology Budapest Hungary 1032
    82 Diagnostic Units Hungary Kft. Budapest Hungary 1036
    83 Szent László Kórház, VI. Fertőző Belosztály Budapest Hungary 1097
    84 Debrecen Medical University Debrecen Hungary 4004
    85 Petz Aladar Megyei Oktato Korhaz, Immunnephrologia es Hypertonia Osztaly Gyor Hungary 9024
    86 Global Hospitals Hyderabaad Andhra Pradesh India 500 004
    87 Department of Nephrology, All India Institute of Medical Sciences New Delhi Ansari Nagar India 110029
    88 Institute of Kidney Diseases and Research (IKRD) and Institute of Transplantation Sciences (ITS) Ahmedabad Asarwa India 380016
    89 Sri Ramachandra Medical College & Research Institute (Deemed University) Porur Chennai India 600 116
    90 M.P. Shah Medical College & G.G. Hospital Jamnagar Gujarat India 361001
    91 PVS Memorial Hospital Ltd. Cochin Kaloor, Kerala India 682017
    92 Apollo Gleneagles Hospital Kolkatta Kankurgachi India 700054
    93 St. Johns Medical College and Hospital, Dept. of Nephrology Bangalore Karnataka India 560 034
    94 M.S. Ramaiah Memorial Hospital Bangalore Karnataka India 560054
    95 Amrita Institute of Medical Sciences Kochin Kerala India 682026
    96 Consultant and Head Department of Nephrology, Kamineni Hospitals Hyderabaad L.B. Nagar India 500068
    97 Apollo Specialty Hospitals, Lake View Road, K.K., Nagar Madurai Tamil Nadu India 625-020
    98 Fortis Hospital, Dept. of Nephrology & Hypertension Noida Uttar Pradesh India
    99 Post Graduate Institute of Medical Education and Research Chandigarh India 160 012
    100 Devaki Hospital Ltd., Dept. of Nephrology Chennai India 600 004
    101 Madras Institute of Nephrology, Vijaya Health Center Chennai India 600 026
    102 Spectra Apollo Research Foundation Chennai India
    103 Medwin Hospital Hyderabaad India 500 001
    104 Nizams Institute of Medical Sciences Hyderabaad India 500 082
    105 Department of Nephrology, CARE Hospital, Banjara Hills Hyderabad India 500034
    106 Armenian Church Trauma Center - Unit of Rabindranath Tagore International Institute of Cardiac Sciences Kolkata India 700-099
    107 Sanjay Ghandi Post Graduate Institute of Medical Sciences Lucknow India 226014
    108 BYL Nair Charitable Hospital & TN Medical College Mumbai India 400 008
    109 Seth G.S. Medical College & KEM Hospital Mumbai India 400 012
    110 P.D. Hinduja National Hospital and Research Center Mumbai India 400016
    111 Department of Nephrology, JSS Hospital, Ramanuja Road Mysore India 570004
    112 Indraprastha Apollo Hospital New Delhi India 110044
    113 Jehangir Hospital, 32 Sassoon Road Pune India 411001
    114 Medical College Trivandrum Trivandrum India 695011
    115 King George Hospital Visakhapatnam India 530002
    116 Dept. of Internal Medicine, Saiful Anwar General Hospital Malang Jl. J.A. Suprapto No. 2 Indonesia 65111
    117 RS Kramat 128 Jakarta Jl. Kramat Raya, Pusat Indonesia 128
    118 RS Hasan Sadikin Bandung Jl. Pasir Kaliki No. 190, Jawa Barat Indonesia 40161
    119 Arcispedale S. Anna, Divisione di Reumatologia Ferrara Corso Giovecca 203 Italy 44100
    120 Azienda Ospedaliera Cattedra di Reumatologia Padova Via Giustiniani, 2 Italy 35128
    121 Universita di Pisa, Dipartimento di Medicina Interna Pisa Via Roma 67 Italy 56126
    122 Ewha Woman's University College of Medicine, Mockdong Hospital Seoul Yangcheon-Gu Korea, Republic of 158-710
    123 Inha University Hospital In Cheon Korea, Republic of 400-711
    124 Bundang Cha General Hospital, Pochon Cha University Kyonggi-do Korea, Republic of 463-712
    125 Pusan National University Hospital Pusan Korea, Republic of 602-739
    126 Seoul National University Hospital, Department of Internal Medicine Seoul Korea, Republic of 110-744
    127 The Hospital for Rheumatic Disease, Hanyang University Medical Center Seoul Korea, Republic of 133-792
    128 Kangnam St. Mary's Hospital, Catholic University of Korea Seoul Korea, Republic of 137-040
    129 St. Mary's Hospital, Catholic University of Korea Seoul Korea, Republic of 150-713
    130 Ajou University Medical Center, Ajou University School of Medicine Suwon Korea, Republic of 442-721
    131 Rayak Hospital Rayak Bekaa Valley Lebanon
    132 Albert Haykel Hospital Haykaliyeh-Tripoli Lebanon
    133 Nabatieh Governmental Hospital Nabatieh Lebanon
    134 Hammoud Hospital University Medical Center Saida Lebanon
    135 Labib Medical Center Saida Lebanon
    136 Department of Medicine, Hospital Pulau Pinang, Pulau Pinang Jalan Residensi Malaysia 10990
    137 CAPD Unit, Queen Elizabeth Hospital, Sabah Kota Kinabalu Malaysia 88586
    138 Department of Medicine, Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, Sarawak Kuching Malaysia 93586
    139 Blvd. Sanchez Taboada 9250-28 - Private Practice Tijuana Baja California Mexico cp22010
    140 Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran", Departmento de inmunologia y Reumatologia Delagacion Tlalpan D.f. Mexico CP 14000
    141 Clínica de Diagnóstico y Tratamiento de las Enfermedades Reumáticas Mexico City D.f. Mexico 06700
    142 Hospital Aranda de la Parra Leon Guanajuato Mexico CP37000
    143 Colomos #2292, Col. Providencia Guadalajara Jalisco Mexico 44620
    144 Centro de Estudios de Investigación Básica y Clínica S.C. Guadalajara Jalisco Mexico 44690
    145 Hospital Star Medica Morelia Michoacan Mexico 58070
    146 Poliplaza Medica Chihuahua Mexico CP 32500
    147 Reumatologia Mexicali Mexico CP 21100
    148 Hospital Privado San José de Ciudad Obregón, S.A. de C.V. Coahuila No. 263 Sur. Col. Centro. Ciudad Obregón Sonora Mexico C.P. 85000
    149 Chung Hua Hospital Cebu Philippines 6000
    150 Davao Doctors Hospital Davao Philippines 8000
    151 Philippine General Hospital Manila Philippines 1000
    152 Joint and Bone Center, University of Santo Tomas Hospital Manila Philippines
    153 Klinika Medycyny, Transplantacyjnej i Nefrologii in Warszawa, Nowogrodzka 59, At SPZOZ Szpital Kliniczny Warszawa Dzieciatka Jezus-Centrum Leczenia Obrażeń, Lindleya 4 Poland 02-005
    154 Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych - Akademickie Centrum Kliniczne - Szpital AMG Gdansk Poland 80-952
    155 Klinika Chorob Wewnetrznych i Reumatologii - Gornoslaskie Centrum Medyczne, SPSK Nr 7 SL A M Katowice Poland 40-635
    156 Oddzial Kiliniczny Nefrologii Hipertensjologii i Transplantologii Nerek SPZOZ, Uniwersytecki Szpital Kliniczny nr 1 Lodz Poland 90153
    157 Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej Lublin Poland 20-954
    158 Akademii Medycznej w Poznaniu, Zaklad Reumatologii i Immunologii Klinicznej Poznan Poland 61-626
    159 Klinika Chorób Tkanki Łącznej Warszawa Poland 02-637
    160 Klinika Nefrologii Dializoterapii I Chorob Wewnetrznych - Samodzielny Publiczny Centralny Szpital Kliniczny Warszawa Poland 02097
    161 Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia Lisboa Av. Prof. Egas Moniz Portugal 1649-035
    162 Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica Porto Largo Prof. Abel Salazar Portugal 4099-001
    163 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Rua Conceicao Fernandes Portugal 4434-502
    164 Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia Lisboa Rua da Junqueira, 126 Portugal 1300
    165 Hospital de Sāo Jeāo, Servico de Nefrologia Porto Portugal 4200-319
    166 RCMI Clinical Research Center, 1st Floor University Hospital Medical Center San Juan Puerto Rico 00935
    167 "Sf. Maria" Clinical Hospital Bucharest Romania 011172
    168 "Ion Stoia" Center of Rheumatic Diseases Bucharest Romania 020983
    169 Emergency Clinical County Hospital Cluj Cluj Napoca Romania 400006
    170 Rehabilitation Clinical Hospital Iasi Romania 700661
    171 Institute of Nephrology and Urology Clinical Centre of Serbia Belgrade Serbia 11000
    172 Institute of Rheumatology Belgrade Serbia 11000
    173 University Medical Centre "Zvezdara", Clinical Department for Renal Diseases, Dimitrija Tucovica 161 Belgrade Serbia 11000
    174 Institute of Prevention, Treatment and Rehabilitation of Rheumatoid and Cardiovascular Patients "Niska Banja" Niska Banja Serbia 18205
    175 Reumatologicka ambulancia Fakultna nemocnica F D Roosevelta Banska Bystrica Slovakia 97517
    176 Reumatologicka ambulancia Fakultna nemocnica s poliklinikou Milosrdni bratia spol s r o Bratislava Slovakia 81465
    177 Hospital Clinic i Provincial de Barcelona, Centre Ciutat, Facultat de Medicina, Servicio de Enfermedades Autoinmunes Barcelona Calle Villarroel, 170 Spain 08036
    178 Hospital Universitario La Paz, Servico de Medicine Interne Planta 10 Madrid Paseo de la Castellana 261 Spain 28046
    179 Hospital Universitari Vall d'Hebron, Servicia Medicina Interna, Edificio General, 3a Planta Barcelona Paseo Valle de Hebron 119-129 Spain 08035
    180 University Lupus Clinic of the Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No 25, Colombo Kynsey Road Sri Lanka 08
    181 Buddhist Dalin Tzu Chi General Hospital, Vice Superintendent Room Dalin Town Chia-Yi county Taiwan 622
    182 Chang Gung Memorial Hospital Kaohsiung Hsien Taiwan 833
    183 Kaohsiung University Medical Hospital Kaohsiung Taiwan 807
    184 Kaohsiung Veterans General Hospital Kaohsiung Taiwan 813
    185 Chang Gung Memorial Hospital - Keelung Keelung city Taiwan 204
    186 Chung Shan Medical University Hospital Taichung City Taiwan 402
    187 China Medical University Hospital Taichung Taiwan 404
    188 National Chang-Kung University Hospital Tainan Taiwan
    189 Taipei Veterans General Hospital - Immunology & Rheumatology Office Taipei Taiwan 112
    190 Chang Gung Memorial Hospital - Taipei Taipei Taiwan
    191 Chang Gung Memorial Hospital Taoyuan Taiwan
    192 Chi Mei Foundation Hospital Yongkang City Taiwan
    193 Department of Medicine, King Chulalongkorn Memorial Hospital Bangkok Thailand 10330
    194 Ramathibodi Hospital - Division of Allergy, Immunology & Rheumatology, Dept. of Medicine Bangkok Thailand 10400
    195 Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine Bangkok Thailand 10400
    196 Donetsk Central Municipal Clinical Hospital #1 Donetsk Ukraine 83114
    197 Kyiv Central Municipal Clinical Hospital Kyiv Ukraine 01023
    198 M.D. Strazhesko Institute of Cardiology AMS Ukraine Kyiv Ukraine 03680
    199 Kyiv Regional Clinical Hospital Kyiv Ukraine 04107
    200 Lviv Municipal Public Clinical Hospital Lviv Ukraine 79013
    201 Vinnitsa Regional Clinical Hospital of MoH of Ukraine Vinnitsa Ukraine 21018

    Sponsors and Collaborators

    • La Jolla Pharmaceutical Company

    Investigators

    • Study Director: Michael J Tansey, MD, Ph.D., Chief Medical Officer, La Jolla Pharmaceutical Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00089804
    Other Study ID Numbers:
    • LJP 394-90-14
    First Posted:
    Aug 17, 2004
    Last Update Posted:
    Apr 1, 2009
    Last Verified:
    Mar 1, 2009

    Study Results

    No Results Posted as of Apr 1, 2009