271. 強直性脊椎炎 [臨床試験数:531,薬物数:343(DrugBank:66),標的遺伝子数:41,標的パスウェイ数:141

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
22 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000957-37-NL18/07/201831/10/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of
2EUCTR2017-000957-37-DE15/11/201714/07/2017Study to test the efficacy and safety of bimekizumab andcertolizumab pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of
3NCT03357471November 3, 201723/11/2017Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseA Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's DiseaseModerate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's DiseaseDrug: e-DeviceUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll70Phase 3United States
4EUCTR2017-000957-37-GR05/10/201713/09/2017Study to test the efficacy and safety of Bimekizumab andCertolizumab Pegol in patients with active ankylosing spondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab Pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of
5NCT03215277October 4, 20175/7/2017A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing SpondylitisA Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Drug: Certolizumab pegol;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll76Phase 2United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-000957-37-CZ25/09/201712/07/2017Study to test the efficacy and safety of bimekizumab and certolizumab pegol in patients with active ankylosing spondylitis A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis Ankylosing Spondylitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of
7EUCTR2015-001894-41-BG12/02/201628/10/2015Multicenter study evaluating certolizumab pegol compared to placebo insubjects with axSpA without x-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION. ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria
8EUCTR2015-001894-41-CZ20/11/201521/08/2015Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without x-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION. ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria
9EUCTR2015-001894-41-HU16/10/201519/08/2015Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without X-ray evidence of ASPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION. ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: CIMZIA certolizumab pegol 200 mg/ml solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB BIOSCIENCES GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Czech Republic;Hungary;Canada;Poland;Australia;Russian Federation;Bulgaria
10EUCTR2015-002284-42-FI18/09/201528/08/2015The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activitINTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specifyTrade Name: Enbrel
Product Name: etanercept
Trade Name: Humira
Product Name: adalimumab
Trade Name: Cimzia
Product Name: certolizumab pegol
Trade Name: Simponi
Product Name: golimumab
Trade Name: Remicade
Product Name: infliximab
READENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1650Phase 1Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02552212September 201515/9/2015Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of ASPhase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of InflammationAxial Spondyloarthritis;Nonradiographic Axial Spondyloarthritis;Nr-axSpABiological: Certolizumab Pegol;Other: PlaceboUCB BIOSCIENCES GmbHNULLCompleted18 YearsN/AAll317Phase 3United States;Australia;Bulgaria;Canada;Czechia;Hungary;Poland;Russian Federation;Taiwan;Czech Republic
12NCT02505542July 201516/7/2015Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to PlaceboA Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to PlaceboAxial Spondyloarthrithis;Ankylosing SpondylitisBiological: Certolizumab Pegol;Other: PlaceboUCB BIOSCIENCES GmbHParexelCompleted18 Years45 YearsAll736Phase 3United States;Belgium;Bulgaria;Czechia;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Taiwan;Turkey;United Kingdom;Czech Republic
13NCT02154425September 201430/5/2014A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating MothersA Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Breast milk sampling;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelCompleted18 YearsN/AFemale17Phase 1United States;Netherlands;Switzerland;France
14EUCTR2013-003812-30-NL21/07/201426/05/2014A multicentre study to measure the transfer of Cimzia from women to infants via the placentaA MULTICENTER POSTMARKETING STUDY TO EVALUATETHE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL INPREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA®(CERTOLIZUMAB PEGOL) Rheumatoid ArthritisAxial spondyloarthritisPsoriatic arthritis
MedDRA version: 17.0Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia
Product Name: Certolizumab pegol / CIMZIA
INN or Proposed INN: CERTOLIZUMAB PEGOL
UCB Biosciences Inc.NULLNot RecruitingFemale: yes
Male: yes
20Phase 1France;United States;Germany;Netherlands;Switzerland
15NCT02019602January 201418/12/2013A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the PlacentaA Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid ArthritisProcedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab PegolUCB BIOSCIENCES, Inc.PPD;ParexelCompleted18 YearsN/AAll37Phase 1United States;France;Netherlands;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2009-011719-19-CZ20/07/201020/07/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 14.1Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Italy;United Kingdom
17EUCTR2009-011719-19-DE19/07/201017/02/2010N/APHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 18.1Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Netherlands;United States;United Kingdom
18EUCTR2009-011719-19-BE02/07/201023/04/2010NAPHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 16.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;United Kingdom;Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Germany;Netherlands
19EUCTR2009-011719-19-NL29/06/201006/05/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 14.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Italy;United Kingdom
20EUCTR2009-011719-19-GB13/05/201015/03/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 14.0 Level: PT Classification code 10051265 Term: Spondyloarthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of CompaniesNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-011719-19-HU13/05/201012/04/2010N/APHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 16.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 16.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
UCB BioSciences GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany;Netherlands
22EUCTR2009-011719-19-FR29/03/201004/02/2010PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA) axial spondyloarthritis (axial SpA)
MedDRA version: 12.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathies
MedDRA version: 12.1Level: LLTClassification code 10051265Term: Spondyloarthropathy
Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: certolizumab pegol
SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of CompaniesNULLNot RecruitingFemale: yes
Male: yes
500Phase 3France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom