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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-000957-37-NL (EUCTR) | 18/07/2018 | 31/10/2017 | Study 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] | 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Netherlands;Moldova, Republic of | ||
| 2 | EUCTR2017-000957-37-DE (EUCTR) | 15/11/2017 | 14/07/2017 | Study to test the efficacy and safety of bimekizumab andcertolizumab 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] | 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Netherlands;United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Germany;Moldova, Republic of | ||
| 3 | NCT03357471 (ClinicalTrials.gov) | November 3, 2017 | 23/11/2017 | Study 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 Disease | A 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 Disease | Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease | Drug: e-Device | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 4 | EUCTR2017-000957-37-GR (EUCTR) | 05/10/2017 | 13/09/2017 | Study to test the efficacy and safety of Bimekizumab andCertolizumab 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] | 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of | ||
| 5 | NCT03215277 (ClinicalTrials.gov) | October 4, 2017 | 5/7/2017 | A Study 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 | Drug: Bimekizumab;Drug: Certolizumab pegol;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 76 | Phase 2 | United States;Czechia;Germany;Greece;Moldova, Republic of;Netherlands;Poland;Russian Federation;Australia |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2017-000957-37-CZ (EUCTR) | 25/09/2017 | 12/07/2017 | Study 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 SPRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Czech Republic;Greece;Poland;Australia;Russian Federation;Netherlands;Germany;Moldova, Republic of | |||
| 7 | EUCTR2015-001894-41-BG (EUCTR) | 12/02/2016 | 28/10/2015 | Multicenter study evaluating certolizumab pegol compared to placebo insubjects with axSpA without x-ray evidence of AS | PHASE 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: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria | ||
| 8 | EUCTR2015-001894-41-CZ (EUCTR) | 20/11/2015 | 21/08/2015 | Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without x-ray evidence of AS | PHASE 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: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Hungary;Czech Republic;Canada;Poland;Australia;Russian Federation;Bulgaria | ||
| 9 | EUCTR2015-001894-41-HU (EUCTR) | 16/10/2015 | 19/08/2015 | Multicenter study evaluating certolizumab pegol compared to placebo in subjects with axSpA without X-ray evidence of AS | PHASE 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: 20.0;Level: LLT;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Taiwan;Czech Republic;Hungary;Canada;Poland;Australia;Russian Federation;Bulgaria | ||
| 10 | EUCTR2015-002284-42-FI (EUCTR) | 18/09/2015 | 28/08/2015 | The 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 activit | INTENT: 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 specify | Trade 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 | READE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1650 | Phase 1 | Finland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02552212 (ClinicalTrials.gov) | September 2015 | 15/9/2015 | Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS | Phase 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 | Axial Spondyloarthritis;Nonradiographic Axial Spondyloarthritis;Nr-axSpA | Biological: Certolizumab Pegol;Other: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 317 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;Hungary;Poland;Russian Federation;Taiwan;Czech Republic |
| 12 | NCT02505542 (ClinicalTrials.gov) | July 2015 | 16/7/2015 | Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo | A 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 Placebo | Axial Spondyloarthrithis;Ankylosing Spondylitis | Biological: Certolizumab Pegol;Other: Placebo | UCB BIOSCIENCES GmbH | Parexel | Completed | 18 Years | 45 Years | All | 736 | Phase 3 | United States;Belgium;Bulgaria;Czechia;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Taiwan;Turkey;United Kingdom;Czech Republic |
| 13 | NCT02154425 (ClinicalTrials.gov) | September 2014 | 30/5/2014 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers | A 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 Arthritis | Procedure: Breast milk sampling;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Completed | 18 Years | N/A | Female | 17 | Phase 1 | United States;Netherlands;Switzerland;France |
| 14 | EUCTR2013-003812-30-NL (EUCTR) | 21/07/2014 | 26/05/2014 | A multicentre study to measure the transfer of Cimzia from women to infants via the placenta | A MULTICENTER POSTMARKETING STUDY TO EVALUATETHE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL INPREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA®(CERTOLIZUMAB PEGOL) | Rheumatoid ArthritisAxial spondyloarthritisPsoriatic arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 17.0;Classification code 10037160;Term: Psoriatic arthritis;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 1 | France;United States;Germany;Netherlands;Switzerland | ||
| 15 | NCT02019602 (ClinicalTrials.gov) | January 2014 | 18/12/2013 | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta | A 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 Arthritis | Procedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Completed | 18 Years | N/A | All | 37 | Phase 1 | United States;France;Netherlands;Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02132234 (ClinicalTrials.gov) | June 2013 | 28/4/2014 | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis | Rheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Hypertension | Drug: Etanercept;Drug: Adalimumab;Drug: Certolizumab;Drug: Infliximab | Jagiellonian University | Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland | Recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Poland |
| 17 | EUCTR2009-011719-19-CZ (EUCTR) | 20/07/2010 | 20/07/2010 | 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) | 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: 14.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Hungary;Czech Republic;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 18 | EUCTR2009-011719-19-DE (EUCTR) | 19/07/2010 | 17/02/2010 | N/A | 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: 18.1;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Netherlands;United States;United Kingdom | ||
| 19 | EUCTR2009-011719-19-BE (EUCTR) | 02/07/2010 | 23/04/2010 | NA | 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: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Germany;Netherlands | ||
| 20 | EUCTR2009-011719-19-NL (EUCTR) | 29/06/2010 | 06/05/2010 | 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) | 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 | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB BioSciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2009-011719-19-GB (EUCTR) | 13/05/2010 | 15/03/2010 | 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) | 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 Companies | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
| 22 | EUCTR2009-011719-19-HU (EUCTR) | 13/05/2010 | 12/04/2010 | N/A | 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: 16.0;Level: PT;Classification code 10051265;Term: Spondyloarthropathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 16.0;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;System 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany;Netherlands | ||
| 23 | EUCTR2009-011719-19-FR (EUCTR) | 29/03/2010 | 04/02/2010 | 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) | 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: 12.1;Level: LLT;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies MedDRA version: 12.1;Classification code 10051265;Term: 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 Companies | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | France;Czech Republic;Hungary;Belgium;Netherlands;Germany;Italy;United Kingdom |