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"
243 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001684-77-HU07/12/202008/12/2020A trial to test whether BI 730357 is effective in patients with active ankylosing spondylitisA 12-weeks Phase II, randomized, double-blind, placebocontrolled, parallel-group, proof-of-concept trial of BI 730357 in patients with active ankylosing spondylitis axial spondyloarthritis
MedDRA version: 21.1Level: LLTClassification code 10041672Term: Spondylitis ankylosingSystem Organ Class: 100000004859;Therapeutic area: Body processes [G] - Physical Phenomena [G01]
Product Code: BI 730357
INN or Proposed INN: BI 730357
Other descriptive name: BI 730357
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Czechia;Hungary;Spain;Belgium;Ukraine;Romania;Georgia;Germany;Moldova, Republic of;Korea, Republic of
2NCT04483700December 202020/7/2020Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug TherapyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug TherapyAnkylosing SpondylitisDrug: Filgotinib;Drug: Placebo to Match FilgotinibGilead SciencesGalapagos NVNot yet recruiting18 YearsN/AAll408Phase 3NULL
3NCT04507659December 20204/8/2020Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing SpondylitisA Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase ? Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Jaktinib Hydrochloride Tablets;Drug: PlaceboSuzhou Zelgen Biopharmaceuticals Co.,LtdNULLNot yet recruiting18 Years65 YearsAll105Phase 2NULL
4NCT04483687December 202020/7/2020Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug TherapyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug TherapyAnkylosing SpondylitisDrug: Filgotinib;Drug: Placebo to Match FilgotinibGilead SciencesGalapagos NVNot yet recruiting18 YearsN/AAll576Phase 3NULL
5NCT04481139October 21, 202015/7/2020A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis SubjectsAnkylosing SpondylitisDrug: SHR0302;Drug: SHR0302 placeboJiangsu HengRui Medicine Co., Ltd.NULLRecruiting18 Years75 YearsAll480Phase 2/Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003229-12-DE30/06/202005/12/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
7EUCTR2019-001177-90-SE30/06/202017/12/2019Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
8EUCTR2019-001177-90-BG07/04/202012/02/2020Study to demonstrate the efficacy, safety and tolerability of an intravenous(i.v.) regimen of secukinumab compared to placebo in subjects with activeaxSpAA randomized, double-blind, placebo-controlled, parallel group, phase IIImulticenter study of intravenous secukinumab to compare efficacy at 16weeks with placebo and to assess safety and tolerability up to 52 weeks insubjects with active Ankylosing Spondylitis or non-radiographic axialSpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Phase 3United States;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Belgium;Brazil;Malaysia;Bulgaria;Sweden;Korea, Republic of
9EUCTR2019-003229-12-ES10/03/202006/03/2020Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;China;Japan;New Zealand;Korea, Republic of
10EUCTR2019-003229-12-GB02/03/202016/12/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-003229-12-HU27/01/202002/12/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Ukraine;Turkey;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Australia;New Zealand;China;Japan;Korea, Republic of
12EUCTR2019-001177-90-GR23/01/202013/11/2019 Study to demonstrate the efficacy, safety and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in subjects with active axSpA A randomized, double-blind, placebo-controlled, parallel group, phase III multicenter study of intravenous secukinumab to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis or non-radiographic axial SpondyloArthritis Axial Spondyloarthritis
MedDRA version: 21.1 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
500 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Philippines;Greece;Thailand;Guatemala;Turkey;Russian Federation;Colombia;Italy;India;Egypt;Czech Republic;Poland;Malaysia;Belgium;Brazil;Bulgaria;Korea, Republic of;Sweden
13EUCTR2019-003229-12-SK14/01/202015/11/2019Evaluation of upadacitinib in adult subjects with axial spondyloarthritisA Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Axial Spondyloarthritis
MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: UPADACITINIB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
690Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Germany;China;Japan;New Zealand;Korea, Republic of
14NCT04156620December 11, 20198/10/2019Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpAA Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritisAnkylosing Spondylitis or Non-radiographic Axial SpondyloarthritisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll500Phase 3United States;Belgium;Brazil;Bulgaria;Colombia;Czechia;Greece;Guatemala;India;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Russian Federation;Sweden;Thailand;Turkey
15NCT04205851November 12, 20194/12/2019Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing SpondylitisAn Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Gimsilumab in Healthy Subjects and Subjects With Ankylosing SpondylitisInflammation;Rheumatic DiseasesDrug: KIN-1901;Drug: PlaceboKinevant Sciences GmbHNULLCompleted18 Years75 YearsAll36Phase 1Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16JPRN-JapicCTI-19486030/9/201916/07/2019A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis Ankylosing SpondylitisIntervention name : UCB4940
INN of the intervention : bimekizumab
Dosage And administration of the intervention : 160mg administered by sc injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., LtdNULLrecruiting18BOTH15Phase 3Japan, Asia except Japan, North America
17EUCTR2018-003933-14-BE19/07/201924/04/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLNot RecruitingFemale: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
18EUCTR2017-003065-95-NL03/07/201925/07/2019 A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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 SPRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Germany;China;Japan
19EUCTR2017-003065-95-GB01/07/201929/03/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis.A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
20EUCTR2018-003933-14-BG21/06/201927/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Estonia;Czech Republic;Spain;Poland;Ukraine;Bulgaria;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2017-003065-95-BG19/06/201910/05/2019 A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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 SRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
22EUCTR2017-003065-95-CZ17/06/201904/06/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
23EUCTR2017-003065-95-FR11/06/201921/05/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
24EUCTR2017-003065-95-DE11/06/201904/02/2019 A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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 SPRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
25NCT03926195May 28, 201919/4/2019Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial SpondyloarthritisA Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial SpondyloarthritisRheumatoid Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographical Axial SpondyloarthritisDrug: Filgotinib;Drug: Placebo;Drug: Standard of CareGalapagos NVGilead SciencesActive, not recruiting21 Years65 YearsMale109Phase 2Belgium;Bosnia and Herzegovina;Bulgaria;Czechia;Estonia;Georgia;Latvia;Poland;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-003933-14-CZ28/05/201929/04/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
27EUCTR2018-003933-14-LV27/05/201907/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
250 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of
28EUCTR2018-003933-14-ES30/04/201921/05/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Galapagos NVNULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
250 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noEstonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
29EUCTR2017-003065-95-ES29/04/201921/05/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Netherlands;China;Japan
30NCT03928743April 25, 201923/4/2019A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bimekizumab;Other: PlaceboUCB Biopharma SRLNULLRecruiting18 YearsN/AAll300Phase 3United States;Belgium;Bulgaria;China;Czechia;France;Germany;Hungary;Japan;Netherlands;Poland;Spain;Turkey;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-003065-95-BE19/04/201926/02/2019A study to evaluate the efficacy and safety ofbimekizumab in subjects with active ankylosingspondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Spain;Turkey;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Netherlands;China;Japan
32EUCTR2017-003065-95-HU16/04/201925/03/2019A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Hungary;Czech Republic;Belgium;Poland;Bulgaria;Germany;United States;Spain;Turkey;United Kingdom;France;Netherlands;China;Japan
33EUCTR2018-003933-14-EE09/04/201914/03/2019A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis. Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
250Phase 2Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia
34ChiCTR18000192272018-11-262018-10-31A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis(AS)A randomized, double-blind, placebo-controlled trial for evaluation of the efficacy and safety of Iguratimod in Chinese patients with active spondyloarthritis(SpA)/ankylosing spondylitis spondyloarthritis(SpA)/ankylosing spondylitis(AS)spondyloarthritis(SpA)/ankylosing spondylitis(AS):Iguratimod;Control group:Placebo;PLA General HospitalNULLPending1665Bothspondyloarthritis(SpA)/ankylosing spondylitis(AS):72;Control group:36;China
35EUCTR2017-004226-15-DK26/10/201805/01/2018 Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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] - Musculoskeletal Diseases [C05]
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noDenmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2018-000226-58-DE18/10/201816/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
37EUCTR2018-000226-58-GB13/08/201815/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
38EUCTR2018-000226-58-BG07/08/201831/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
39EUCTR2018-000226-58-FR12/07/201823/04/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
40NCT03552276July 11, 20184/5/2018A Long Term Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis.A Multiple-Dose, Long-Term Extension Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Psoriatic Arthritis and Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Who Have Previously Completed Studies With Tildrakizumab.Psoriatic Arthritis;Ankylosing Spondylitis;Non-Radiographic Axial SpondyloarthritisDrug: tildrakizumab 200 mg (two 1-mL injections of 100 mg/mL);Drug: tildrakizumab 100 mg (one 1-mL injection of 100 mg/mL + 1 mL placebo)Sun Pharma Global FZENULLActive, not recruiting18 YearsN/AAll540Phase 2/Phase 3United States;Argentina;Hungary;Mexico;Poland;Russian Federation;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-000226-58-CZ09/07/201804/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
42EUCTR2018-000226-58-AT06/07/201814/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
43EUCTR2018-000226-58-ES04/07/201809/05/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Germany;China;Korea, Republic of
44EUCTR2018-000226-58-HU26/06/201826/04/2018A Phase 3 Study Of The Efficacy And Safety Of Tofacitinib In Patients With Active Ankylosing Spondylitis (AS)A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS) Ankylosing spondylitis (AS)
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]
Trade Name: Xeljanz
Product Name: Tofacitinib 5 mg
Product Code: CP-690,550
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany;China;Korea, Republic of
45NCT03502616June 7, 201811/4/2018Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)Ankylosing SpondylitisDrug: TofacitinibPfizerNULLCompleted18 YearsN/AAll270Phase 3United States;Australia;Bulgaria;Canada;China;Czechia;France;Hungary;Israel;Korea, Republic of;Poland;Russian Federation;Turkey;Ukraine;Slovakia;Spain;Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2017-000431-14-HR06/04/201819/04/2018A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3United States;Portugal;Finland;Spain;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
47EUCTR2017-000431-14-DE21/02/201831/07/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
48NCT03447704February 9, 201821/2/2018International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing SpondylitisAn International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: BCD-085;Other: placeboBiocadNULLActive, not recruiting18 Years65 YearsAll228Phase 3Russian Federation
49EUCTR2017-000431-14-SE24/01/201820/12/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
50EUCTR2017-000431-14-NL05/01/201822/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2;Phase 3United States;Portugal;Finland;Spain;Switzerland;Hungary;Canada;Poland;Australia;Denmark;Netherlands;Japan;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2017-000431-14-GB28/12/201708/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
52EUCTR2017-000431-14-CZ13/12/201708/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Germany;Netherlands;Japan;New Zealand;Sweden;Korea, Republic of;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;United States;Portugal;Finland;Spain;Hungary
53EUCTR2017-000431-14-PL15/11/201720/10/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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]
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Finland;Spain;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
54EUCTR2017-000431-14-BE15/11/201730/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
55EUCTR2017-000431-14-FR13/11/201719/07/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2;Phase 3Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;Portugal;United States;Finland;Spain;Switzerland;United Kingdom;France;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02980705November 6, 201730/11/2016Efficacy and Safety Study of SUNPG1622A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloarthritisActive Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisDrug: SUNPG1622 I dose;Drug: Placebo doseSun Pharma Global FZENULLTerminated18 YearsN/AAll180Phase 2United States
57NCT03329885November 2, 201731/10/2017A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious PsoriasisA Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe PsoriasisRheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic SteatohepatitisDrug: BMS-986251;Other: PlaceboBristol-Myers SquibbNULLTerminated18 Years70 YearsAll38Phase 1/Phase 2Netherlands
58NCT03178487October 24, 20175/6/2017A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis ( SELECT Axis 1 )A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing SpondylitisAnkylosing Spondylitis (AS)Drug: Upadacitinib;Drug: Upadacitinib PlaceboAbbVieNULLActive, not recruiting18 YearsN/AAll187Phase 2United States;Australia;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Spain;Sweden;United Kingdom
59EUCTR2017-000431-14-PT09/10/201709/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Portugal;United States;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
60NCT03215277October 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
61EUCTR2017-000431-14-ES02/10/201708/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2;Phase 3Portugal;United States;Hungary;Canada;Spain;Australia;New Zealand;Japan;Switzerland;Korea, Republic of
62NCT04480359October 1, 201716/7/2020Bawei Shenqi Pill in the Treatment of Ankylosing SpondylitisThe Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Bawei Shenqi Pill;Drug: Bawei Shenqi Pill placebo;Drug: MeloxicamShanghai University of Traditional Chinese MedicineNULLRecruiting18 Years70 YearsAll80Phase 2/Phase 3China
63EUCTR2017-000431-14-HU26/09/201704/09/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
228Phase 2;Phase 3United States;Hungary;Canada;Australia;New Zealand;Japan;Switzerland;Korea, Republic of
64EUCTR2017-000431-14-DK25/09/201725/07/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
228 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Finland;Spain;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of
65EUCTR2017-000431-14-FI06/09/201701/08/2017A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects with Active Ankylosing Spondylitis Active 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: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2;Phase 3Denmark;Netherlands;Germany;Japan;New Zealand;Sweden;Korea, Republic of;United States;Portugal;Finland;Spain;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2016-001102-42-GB24/05/201722/03/2017 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.1 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
285 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
67NCT03140657April 29, 201728/4/2017The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis PatientsThe Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis PatientsAnkylosing SpondylitisDrug: Nanocurcumin;Drug: PlaceboTabriz University of Medical SciencesNULLCompleted23 Years46 YearsAll24Phase 2Iran, Islamic Republic of
68EUCTR2016-003636-21-BE12/04/201713/02/2017A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to 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] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Estonia;Czech Republic;Poland;Spain;Belgium;Ukraine;Bulgaria;Germany
69EUCTR2016-003636-21-BG11/04/201703/02/2017A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to 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] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
70EUCTR2016-003936-19-ES04/04/201710/02/2017A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]SUN Pharmaceuticals Global FZENULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2016-003936-19-HU20/03/201706/01/2017A Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Patients with Active Ankylosing Spondylitis or Non-Radiographic Axial SpondyloarthritisA Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects with Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis Ankylosing spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]SUN Pharmaceuticals Global FZENULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Mexico;Poland;Spain;Germany;United Kingdom
72NCT03117270March 7, 201730/3/2017A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Efficacy and Safety of Filgotinib Administered for 12 Weeks to Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: filgotinib;Drug: Placebo Oral TabletGalapagos NVNULLCompleted18 YearsN/AAll116Phase 2Belgium;Bulgaria;Czechia;Estonia;Poland;Spain;Ukraine
73EUCTR2016-003636-21-CZ14/02/201719/12/2016A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to 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] - Musculoskeletal Diseases [C05]
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noEstonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
74EUCTR2016-001102-42-BG10/02/201705/01/2017 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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
285 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
75EUCTR2016-001102-42-DE09/02/201716/11/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2016-003636-21-ES01/02/201722/12/2016A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
77EUCTR2016-003636-21-EE26/01/201708/12/2016A study to assess the efficacy and safety of the study drug, filgotinib, administered for 12 weeks to subjects with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis ankylosing spondylitis
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Czech Republic;Estonia;Poland;Belgium;Spain;Ukraine;Bulgaria;Germany
78EUCTR2016-001102-42-ES28/12/201627/10/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.0Level: 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
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
79EUCTR2016-001102-42-CZ16/12/201603/11/2016 A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB 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
285 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany;United Kingdom
80EUCTR2016-001102-42-HU21/11/201628/09/2016A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS Ankylosing Spondylitis
MedDRA version: 19.0Level: 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
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
285Phase 2United States;Czech Republic;Hungary;Canada;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT02896127October 18, 20164/5/2016Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes, to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing SpondylitisAnkylosing SpondyloarthritisDrug: Secukinumab;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll458Phase 3China;Czechia;Korea, Republic of;United Kingdom;Czech Republic
82NCT02963506October 201610/11/2016A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisOther: Placebo;Drug: BimekizumabUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll303Phase 2United States;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic
83EUCTR2015-005021-39-CZ15/09/201614/07/2016Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 Ankylosing Spondyloarthritis
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] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
454 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noCzech Republic;Korea, Democratic People's Republic of;China;United Kingdom
84NCT02685904September 6, 20164/2/2016A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing SpondylitisAnkylosing SpondylitisBiological: ENIA11;Biological: PlaceboMycenax Biotech Inc.TSH Biopharm Corporation LimitedTerminated20 YearsN/AAll10Phase 3Taiwan
85NCT02763111September 20163/4/2016Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing SpondylitisInternational Multi-center Comparative Randomized Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: BCD-085;Other: PlaceboBiocadNULLCompleted18 Years65 YearsAll88Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-005021-39-GB04/08/201612/07/2016Study of efficacy and safety of secukinumab in patients with Ankylosing Spondylitis.A randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab in prefilled syringes, to compare efficacy at 16 weeks with placebo and to assess safety and tolerability up to 52 weeks in subjects with active Ankylosing Spondylitis. - MEASURE 5 Ankylosing Spondyloarthritis
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] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
454 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noCzech Republic;Korea, Democratic People's Republic of;China;United Kingdom
87NCT02763046May 31, 20163/5/2016Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the NSAID-sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis (ASTRUM)Ankylosing SpondylitisDrug: Secukinumab (AIN457) 150 mg s.c.;Drug: Placebo - Secukinumab (AIN457) 150 mg s.c.Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll211Phase 4Germany
88NCT02538341May 201618/8/2015Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's DiseaseBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityActive, not recruiting50 YearsN/AAll617Phase 2United States
89EUCTR2015-004575-74-DE16/03/201618/02/2016Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitisA randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM) - ASTRUM 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] - Musculoskeletal Diseases [C05]
Novartis Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesGermany
90EUCTR2015-001894-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2015-001894-41-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
92EUCTR2015-001894-41-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
93NCT02552212September 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
94ChiCTR-IPR-150067532015-08-012015-07-15A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of methotrexate in Chinese patients with active non-radiographic axial spondyloarthritis(SpA)/ankylosing spondylitis.A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of methotrexate in Chinese patients with active non-radiographic axial spondyloarthritis(SpA)/ankylosing spondylitis. spondyloarthritis(SpA)/ankylosing spondylitis(AS)AS+peripheral arthritis:MTX;AS+peripheral arthritis:placebo;AS:MTX;AS:placebo;nr-axial SpA+peripheral arthritis:MTX;nr-axial SpA+peripheral arthritis:placebo;nr-xial SpA:MTX;nr-xial SpA:placebo;Department of rheumatology of the Chinese PLA General HospitalNULLPendingBothAS+peripheral arthritis:77;AS+peripheral arthritis:77;AS:77;AS:77;nr-axial SpA+peripheral arthritis:77;nr-axial SpA+peripheral arthritis:77;nr-xial SpA:77;nr-xial SpA:77;China
95EUCTR2013-005575-41-GB28/07/201527/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;United Kingdom;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT02505542July 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
97EUCTR2013-005575-41-BG28/05/201518/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
98NCT02159053May 18, 201528/2/201416-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Biological: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll350Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Denmark;Finland;Germany;Greece;Italy;Netherlands;Norway;Poland;Russian Federation;Slovakia;Spain;Switzerland;United Kingdom;Czech Republic;Mexico
99EUCTR2013-005575-41-ES11/05/201503/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 17.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
324Phase 3Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany;United States;Slovakia;Greece;Finland
100EUCTR2013-005575-41-PL04/05/201519/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2013-005575-41-NO29/04/201523/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 17.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Netherlands;Germany;Norway
102EUCTR2013-005575-41-DE27/04/201503/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
103EUCTR2013-005575-41-SK16/04/201513/03/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
104EUCTR2013-005575-41-DK13/04/201525/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Denmark;Australia;Bulgaria;Norway;Netherlands;Germany
105EUCTR2013-005575-41-NL13/04/201510/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2013-005575-41-FI08/04/201520/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
107EUCTR2013-005575-41-GR02/04/201529/04/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
324Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
108EUCTR2013-005575-41-CZ31/03/201530/01/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
109EUCTR2013-005575-41-AT23/03/201505/02/201516-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Slovakia;Greece;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Australia;Denmark;Bulgaria;Norway;Netherlands;Germany
110EUCTR2013-005575-41-IT05/03/201511/03/201616-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitisA randomized, double-blind, placebo-controlled, phase III multicenter study of subcutaneous secukinumab (150 mg) with and without a subcutaneous loading regimen to assess efficacy, safety, and tolerability up to 2 years in patients with active ankylosing spondylitis - MEASURE 4 Ankylosing Spondylitis
MedDRA version: 18.1Level: LLTClassification code 10002555Term: Ankles swollenSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
NOVARTIS FARMA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
324Phase 3Slovakia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2014-000241-74-DE30/12/201401/10/2014A Study of Golimumab in Participants with Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Ankylosing Spondylitis - GO - ALIVE Ankylosing spondylitis (AS)
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: golimumab
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Human anti-TNFa monoclonal antibody
Janssen Biologics, BVNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Mexico;Canada;Poland;Brazil;Ukraine;Romania;Australia;Russian Federation;Germany;Korea, Republic of
112NCT02313727December 20141/12/2014Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic ProgressionCombined Treatment With TNF (Tumor Necrosis Factor) Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic ProgressionAnkylosing SpondylitisDrug: Pamidronate;Other: Placebo (NaCl 0.9%)Bnai Zion Medical CenterJanssen-Cilag Ltd.Not yet recruiting18 YearsN/AMale30Phase 4Israel
113EUCTR2011-005689-39-SK24/09/201407/07/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
114NCT02186873September 3, 20148/7/2014A Study of Golimumab in Participants With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: GolimumabJanssen Research & Development, LLCNULLCompleted18 YearsN/AAll208Phase 3United States;Australia;Canada;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Ukraine;Brazil;Romania
115EUCTR2011-005689-39-NL01/09/201423/06/2014A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01870284July 20143/6/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Ixekizumab;Drug: Placebo;Drug: AdalimumabEli Lilly and CompanyNULLWithdrawn18 YearsN/ABoth0Phase 3United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
117EUCTR2013-001090-24-NO29/04/201407/03/201416-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Germany;Norway;United Kingdom;Sweden
118EUCTR2013-001090-24-GB26/03/201431/12/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
119EUCTR2013-003666-13-DE25/03/201401/11/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 18.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
212Phase 2France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
120EUCTR2013-003666-13-NL07/03/201403/01/2014BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 17.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer-Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
255Phase 2France;United States;Hong Kong;Taiwan;Finland;Belgium;Spain;Germany;Netherlands;Italy;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2013-003666-13-BE28/02/201413/12/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 18.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
212Phase 2France;United States;Hong Kong;Taiwan;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of
122EUCTR2013-001090-24-GR25/02/201409/12/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
123EUCTR2013-001090-24-BE13/02/201414/01/201416-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3United Kingdom;Sweden;United States;Portugal;Czech Republic;Mexico;Greece;Spain;Belgium;Russian Federation;Norway;Germany
124NCT02047110January 28, 201424/1/2014BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.Ankylosing Spondylitis (AS)Drug: placebo for risankizumab;Drug: risankizumabAbbVieBoehringer IngelheimCompleted18 Years70 YearsAll159Phase 2Belgium;Finland;France;Germany;Hong Kong;Italy;Korea, Republic of;Netherlands;Spain;Taiwan;United States
125EUCTR2013-001090-24-PT23/01/201414/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 17.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
222 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2011-005689-39-DE20/01/201424/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
208Phase 2United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of
127NCT02008916January 14, 20148/12/201316-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis PatientsA Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Secukinumab;Drug: Placebo secukinumabNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll226Phase 3United States;Belgium;Czechia;Germany;Greece;Mexico;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;Norway;Sweden
128EUCTR2013-003666-13-IT09/01/201411/11/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. Ankylosing Spondylitis
MedDRA version: 16.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
INN or Proposed INN: N.A.
Other descriptive name: BI 655066
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Spain;Belgium;Netherlands;Germany;Italy;Korea, Republic of
129EUCTR2013-001090-24-DE08/01/201424/10/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 18.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
130EUCTR2013-001090-24-CZ30/12/201308/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years 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] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
222Phase 3Portugal;United States;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2013-001090-24-ES26/12/201312/11/201316-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patientsA randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 16.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Other descriptive name: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Portugal;Czech Republic;Mexico;Greece;Belgium;Spain;Russian Federation;Norway;Germany;United Kingdom;Sweden
132EUCTR2013-003666-13-ES26/12/201324/10/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 16.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
INN or Proposed INN: -
Other descriptive name: BI 655066
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Taiwan;Hong Kong;Finland;Belgium;Spain;Netherlands;Germany;Italy;Korea, Republic of
133EUCTR2013-003666-13-FI13/12/201331/10/2013BI 655066 proof of concept dose finding study in ASA 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8 Ankylosing Spondylitis
MedDRA version: 16.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BI 655066 90 mg/ml
Other descriptive name: BI 655066
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
212Phase 2United States;France;Hong Kong;Taiwan;Finland;Spain;Belgium;Germany;Netherlands;Italy;Korea, Republic of
134NCT01863732November 6, 201323/5/2013Extension in AS: Sustainability of Benefits, Safety and TolerabilityAn Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: Secukinumab;Other: Placebo (Pbo)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll274Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
135EUCTR2011-002325-22-ES28/10/201308/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2011-002325-22-BE28/10/201309/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany
137EUCTR2011-002325-22-DE25/10/201309/08/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
138NCT02538757October 201318/8/2015Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE)Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory ArthritisBiological: Herpes Zoster Vaccine;Drug: PlaceboUniversity of Alabama at BirminghamOregon Health and Science UniversityActive, not recruiting50 YearsN/AAll125Phase 2United States
139EUCTR2011-002325-22-HU26/09/201317/07/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
MedDRA version: 16.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Ixekizumab
Product Code: LY2439821
INN or Proposed INN: Ixekizumab
Other descriptive name: Monoclonal Antibody (MAb)
Trade Name: Adalimumab
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Eli Lilly & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
140EUCTR2011-002325-22-GB26/09/201318/06/2013Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 Spondylitis, Ankylosing
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] - Musculoskeletal Diseases [C05]
Eli Lilly & CompanyNULLNot Recruiting Female: yes
Male: yes
408 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2011-005689-39-CZ07/08/201323/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
142EUCTR2011-005689-39-HU27/06/201322/05/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 17.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc, 235 East 42nd Street, New York 10017NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of
143EUCTR2011-005689-39-ES26/06/201324/06/2013A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) Ankylosing Spondylitis (AS)
MedDRA version: 16.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Pfizer Inc. 235 East 42nd Street, New York, 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Korea, Republic of
144ChiCTR-TRC-130034492013-04-252013-06-07A multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing SpondylitisA multicenter, randomized, double-blind, placebo-controlled, Phase II clinical study of Thalidomide in the treatment of Ankylosing Spondylitis Ankylosing SpondylitisThalidomide 150mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd, po., to the end;Thalidomide 100mg:Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end;Control group:Placebo po.;The General Hospital of People's Liberation ArmyNULLCompleted1865BothThalidomide 150mg:80;Thalidomide 100mg:80;Control group:40;2 (Phase 2 study)China
145EUCTR2011-001555-37-EE19/04/201319/03/2013Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 18.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT01786668April 20136/2/2013Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing SpondylitisA Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)Ankylosing SpondylitisDrug: Tofacitinib 2 mg;Drug: Tofacitinib 5 mg;Drug: Tofacitinib 10 mg;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll208Phase 2United States;Canada;Czech Republic;Germany;Hungary;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan
147NCT02201043February 201323/7/2014Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing SpondylitisAnkylosing SpondylitisDrug: Thalidomide 150mg;Drug: Thalidomide 100mg;Drug: PlaceboShanghai Pharmaceuticals Holding Co., LtdNULLCompleted18 Years65 YearsBoth197Phase 2China
148EUCTR2012-000046-35-DE20/12/201219/09/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
149EUCTR2011-001555-37-NL05/12/201215/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Germany;Netherlands;Sweden
150EUCTR2011-001555-37-BG14/11/201214/08/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
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] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;South Africa;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2012-000046-35-ES13/11/201226/09/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 15.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
222Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
152EUCTR2012-000046-35-NL30/10/201216/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3Italy;Czech Republic;Canada;Singapore;Netherlands;Germany;United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom
153NCT01649375October 18, 201220/7/201216 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing SpondylitisAnklyosing SpondylitisDrug: Secukinumab (75 mg);Drug: Placebo;Drug: Secukinumab (150 mg)Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll219Phase 3United States;Austria;Canada;Czechia;Finland;Germany;Italy;Netherlands;Russian Federation;Singapore;Spain;Switzerland;United Kingdom;Czech Republic
154EUCTR2012-000046-35-FI10/10/201228/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3United States;Finland;Spain;Austria;Russian Federation;Switzerland;United Kingdom;Italy;Czech Republic;Canada;Singapore;Germany;Netherlands
155EUCTR2011-001555-37-DE20/09/201208/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 18.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2012-000046-35-GB17/09/201220/07/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis - MEASURE 2 Ankylosing spondylitis
MedDRA version: 19.1Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: COSENTYX
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
219Phase 3Spain;United States;Finland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Singapore;Germany;Netherlands
157EUCTR2011-001555-37-GB04/09/201216/04/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
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] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
158NCT01694264September 1, 201224/9/2012Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFaA Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa TreatmentChronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic ArthritisDrug: Entecavir;Drug: PlaceboSeoul National University HospitalKonkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro HospitalTerminated16 Years85 YearsAll43Phase 3Korea, Republic of
159EUCTR2011-001555-37-CZ14/08/201230/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
160EUCTR2011-001555-37-SE09/08/201229/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2012-000046-35-IT31/07/201202/08/2012Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS)A randomized, double-blind, placebo-controlled phase III multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
NOVARTIS FARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
222Phase 3United States;Finland;Spain;Austria;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Singapore;Netherlands;Germany
162EUCTR2011-001555-37-SK31/07/201215/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
163EUCTR2011-001555-37-ES23/07/201228/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
164EUCTR2011-001555-37-AT03/07/201230/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 19.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
165EUCTR2011-001555-37-PL30/06/201229/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
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] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2011-001555-37-HU13/06/201202/05/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
456Phase 3United States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
167EUCTR2011-001555-37-FR06/06/201223/08/2012Phase 3 study to evaluate safety and effectiveness of oral Apremilast (CC-10004) in patients with ankylosing spondylitisA phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in the treatment of active ankylosing spondylitis Ankylosing spondylitis (AS)
MedDRA version: 14.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
456 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Estonia;Slovakia;Spain;Austria;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden
168NCT01583374May 2, 201220/4/2012Study of Apremilast to Treat Subjects With Active Ankylosing SpondylitisA PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITISAnkylosing SpondyloarthritisDrug: Apremilast tablet 20 mg;Drug: Apremilast tablet 30 mg BID;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll490Phase 3United States;Australia;Austria;Bulgaria;Canada;Czechia;Estonia;France;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Slovakia;Spain;Sweden;United Kingdom;Czech Republic
169EUCTR2010-024529-18-BE16/12/201120/10/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 16.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
170EUCTR2010-024529-18-DE28/11/201101/08/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 16.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2010-024529-18-BG14/11/201109/11/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE-1 Ankylosing spondylitis
MedDRA version: 17.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands
172NCT01358175October 201119/5/201116 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing SpondylitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: Secukinumab (75 mg);Drug: Secukinumab (150 mg);Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll371Phase 3United States;Belgium;Bulgaria;Canada;France;Germany;Italy;Mexico;Netherlands;Peru;Russian Federation;Taiwan;Turkey;United Kingdom
173EUCTR2010-024529-18-GB02/08/201118/07/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis - MEASURE 1 Ankylosing spondylitis
MedDRA version: 16.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
350United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Netherlands;Germany
174EUCTR2010-024529-18-IT25/07/201129/12/20112-year study of secukinumab treatment in patients with active Ankylosing SpondylitisA randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 14.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
350Taiwan;Mexico;Canada;Belgium;Turkey;Peru;Bulgaria;Russian Federation;Germany;United Kingdom;Italy
175EUCTR2009-017443-34-BE16/05/201108/10/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Phase 2;Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Bulgaria;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
176EUCTR2009-017488-40-BE22/03/201101/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
177EUCTR2009-017443-34-DE17/01/201102/09/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;United Kingdom;Germany;Belgium;Bulgaria;Spain;Italy;Lithuania
178EUCTR2009-017443-34-BG07/01/201124/11/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
179ChiCTR-TRC-110011932011-01-012011-02-22Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trialTripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial ankylosing spondylitisTreatment group: tripterygium wilfordii tablets ;Control group:Placebo;Jiangsu Provincial Hospital of Traditional Chinese MedicineNULLCompleted1860BothTreatment group:66;Control group:22;China
180EUCTR2009-017488-40-ES14/12/201006/10/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF.A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF. Ankylosing SpondylitisEspondilitis Anquilosante
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Belgium;Spain;Lithuania;Denmark;Bulgaria;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
181EUCTR2009-017443-34-ES14/12/201006/10/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF.A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF. Ankylosing Spondylitis (AS)Espondilitis anquilosante (EA)
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
182EUCTR2009-017488-40-BG08/12/201022/11/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
183EUCTR2009-017488-40-DK16/11/201016/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
184EUCTR2009-017488-40-LT02/11/201019/08/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
185EUCTR2009-017443-34-LT02/11/201018/08/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2009-017443-34-GB01/11/201009/08/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
502 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noCzech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
187EUCTR2009-017488-40-GB01/11/201009/08/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
188EUCTR2009-017443-34-CZ27/10/201029/09/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
189EUCTR2009-017488-40-DE18/10/201002/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
190EUCTR2009-017488-40-CZ12/10/201020/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;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
191NCT01248793October 201024/11/2010Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing SpondylitisA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Placebo;Drug: Golimumab;Drug: Golimumab (placebo group)Centocor, Inc.NULLCompleted18 YearsN/AAll213Phase 3China
192NCT01209689October 201024/9/2010A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist TherapyA Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist TherapySpondylitis, AnkylosingDrug: Tocilizumab;Drug: PlaceboHoffmann-La RocheNULLTerminated18 YearsN/AAll113Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Lithuania;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom
193NCT01208207September 27, 201022/9/2010A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing SpondylitisSpondylitis, AnkylosingDrug: Part I - etoricoxib 60 mg;Drug: Part I - etoricoxib 90 mg;Drug: Part I- naproxen 1000 mg;Drug: Part I - Placebo to naproxen 500 mg;Drug: Part II- etoricoxib 60 mg;Drug: Part II- etoricoxib 90 mg;Drug: Part II- naproxen 1000 mg;Drug: Part I - Placebo to etoricoxib 60 mg;Drug: Part I - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to etoricoxib 60 mg;Drug: Part II - Placebo to etoricoxib 90 mg;Drug: Part II- Placebo to naproxen 500 mgMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll1015Phase 3Argentina;Austria;Belgium;Canada;Colombia;Czech Republic;Estonia;Finland;France;Germany;Hungary;India;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States
194EUCTR2009-017443-34-IT22/09/201028/09/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 14.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
195EUCTR2009-017488-40-IT22/09/201028/09/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy - NDA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy - ND Ankylosing Spondylitis
MedDRA version: 9.1Level: LLTClassification code 10002556
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2009-017488-40-SK13/09/201016/08/2010A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapyA randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
197EUCTR2009-017443-34-SK13/09/201017/08/2010A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapyA Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy Ankylosing Spondylitis
MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: RoActemra®
Product Code: Ro 487-5733/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
198NCT01209702September 201024/9/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDsA Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDsSpondylitis, AnkylosingBiological: tocilizumab;Drug: PlaceboHoffmann-La RocheNULLTerminated18 YearsN/AAll306Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;France;Germany;India;Italy;Lithuania;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom;Mexico;Netherlands
199EUCTR2009-011719-19-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
200EUCTR2009-011719-19-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2009-011719-19-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
202EUCTR2009-011719-19-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
203EUCTR2009-011719-19-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
204EUCTR2009-011719-19-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
205ChiCTR-TRC-110012742010-04-012011-01-28Integrated Traditional Chinese and Western medicine for ankylosing spondylitisintegrated Traditional Chinese and Western medicine for ankylosing spondylitis with Gan-shen deficiency and Moist Heat Arthralgia Spasm Syndrome type ankylosing spondylitis;M45.911B group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;C group:Qiangji Granule placebo, Sulfasalazine, Ibuprofen;School of Chinese Medicine Southern Medical UniversityNULLCompleted1860BothB group:120;C group:180;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2009-011719-19-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
207EUCTR2009-016068-35-ES22/02/201016/12/2009Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGNEstudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN Espondilitis anquilosante___________________________Ankylosing Spondylitis
MedDRA version: 12.0Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Sanofi-aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania
208NCT01061723February 20102/2/2010Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing SpondylitisA Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)Ankylosing SpondylitisDrug: Sarilumab;Drug: PlaceboSanofiRegeneron PharmaceuticalsCompleted18 Years75 YearsAll301Phase 2United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Lithuania;Netherlands;Poland;Spain;Turkey;Czech Republic
209NCT01114880January 20105/2/2010Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisA Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Study of Adalimumab in Adult Chinese Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab;Other: placeboAbbottNULLCompleted18 Years65 YearsAll344Phase 3China
210EUCTR2009-015515-40-NL20/11/200928/09/2009PREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVASPREVENTION OF THE PROGRESSION OF VERY EARLY SYMPTOMSINTO ANKYLOSING SPONDYLITIS: A PLACEBO CONTROLLED TRIAL WITH ETANERCEPT - PREVAS The diagnosis of Ankylosing Spondylitis (AS) requires radiographically proven sacroiliitis.Inflammation on MRI is a prognostic factor for the development of AS. The aim is the decrease of inflammation on MRI of the SI joint and/or spine by giving them, a short period, anti-TNF therapy. The study is designed as a randomized, double-blind, placebo-controlled trial. After inclusion patients are randomly assigned to the etanercept- or placebo-arm of the study in a 1:1 ratio during 16 weeks.Trade Name: EnbrelWyeth Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT00844805September 200913/2/2009Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis TrialAnkylosing Spondylitis;Axial SpondyloarthritisDrug: Infliximab;Drug: Placebo;Drug: NaproxenMerck Sharp & Dohme Corp.NULLCompleted18 Years48 YearsAll158Phase 3Austria;Belgium;Denmark;France;Germany;Hungary;Korea, Republic of;Russian Federation;Ukraine;United States
212NCT00944658August 200920/7/2009Spondylitis Trial of Apremilast for Better Rheumatic TherapyRandomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004)in the Treatment of Ankylosing Spondylitis (AS)Ankylosing SpondylitisDrug: Apremilast;Drug: Placebo (sugar pill)Imperial College LondonCelgene CorporationCompleted18 YearsN/AAll38Phase 2United Kingdom
213EUCTR2007-003096-39-IT29/07/200927/03/2009Effects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CRESTEffects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CREST Ankylosing Spondylitis
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: Enbrel
INN or Proposed INN: Etanercept
WYETH LEDERLENULLNot RecruitingFemale: yes
Male: yes
Italy
214EUCTR2008-004229-40-GB09/03/200922/11/2010Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS) - START - Spondylitis Trial of Apremilast for better Rheumatic TherapyRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Ankylosing Spondylitis (AS) - START - Spondylitis Trial of Apremilast for better Rheumatic Therapy Ankylosing Spondylitis
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: Apremilast
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
215EUCTR2008-007510-30-PL06/03/200903/02/2009A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYA PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPY ANKYLOSING SPONDYLITIS
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Product Name: ARRY-371797Array BioPharma Inc.NULLNot RecruitingFemale: yes
Male: yes
168Phase 2Hungary;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
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PhaseCountries
216NCT00809159March 200916/12/2008Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing SpondylitisRandomized, Placebo Controlled Double Blind, Multi-center Phase II Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Moderate to Severe Ankylosing SpondylitisAnkylosing SpondylitisBiological: AIN457;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years65 YearsAll60Phase 2United States;Germany;Netherlands;United Kingdom
217EUCTR2008-002631-33-NL23/02/200917/09/2008Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitisRandomized, double-blind, placebo-controlled, multi-center, phase II, proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 ankylosing spondylitis
MedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;United Kingdom;Netherlands
218EUCTR2008-007510-30-HU09/02/200929/12/2008A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYA PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPY ANKYLOSING SPONDYLITIS
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Product Name: ARRY-371797Array BioPharma Inc.NULLNot RecruitingFemale: yes
Male: yes
126Phase 2Hungary;Poland
219EUCTR2008-002631-33-GB14/01/200925/07/2008Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209 Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Germany;United Kingdom;Netherlands
220NCT00811499December 16, 200817/12/2008A Study of ARRY-371797 in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisDrug: ARRY-371797, p38 inhibitor; oral;Drug: PlaceboPfizerNULLTerminated18 YearsN/AAll25Phase 2United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2008-002631-33-DE15/12/200820/08/2008Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom;Germany;Netherlands
222NCT00889694October 200827/4/2009Clinical Study of Tripterygium Capsule to Treat Early Ankylosing SpondylitisClinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical TrialEarly Ankylosing SpondylitisDrug: Tripterygium;Drug: Sulfasalazine;Drug: placeboSun Yat-sen UniversityNULLEnrolling by invitation18 Years65 YearsBoth80Phase 2/Phase 3NULL
223EUCTR2007-003358-27-DE02/05/200821/11/2007Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira StudyPhase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study Juvenile ankylosing spondylitis
MedDRA version: 10Level: LLTClassification code 10002556Term:
Trade Name: Humira®
INN or Proposed INN: adalimumab
Center of Pediatrics and Neonatology, Asklepios Clinic Sankt AugustinNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
224EUCTR2006-002748-27-HU01/04/200830/01/2008A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitis
MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
225NCT00953979January 20085/8/2009Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing SpondylitisA Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical TrialAnkylosing Spondylitis;TreatmentDrug: kunxian capsuleGu JieruoChina-Japan Friendship Hospital;Dongguan People's Hospital;Zhanjiang People's Hospital;Huashan HospitalCompleted18 Years65 YearsBoth126Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2006-002748-27-NL13/04/200720/11/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitis
MedDRA version: 8.1Level: LLTClassification code 10048811Term: Bechterew's disease
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
227NCT00434044February 20079/2/2007Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing SpondylitisMulticenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 YearsN/ABoth150Phase 3NULL
228EUCTR2006-002748-27-DE15/01/200715/12/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitisTrade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
229NCT00420238January 20078/1/2007Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing SpondylitisAnkylosing SpondylitisDrug: Etanercept (Enbrel);Other: PlaceboWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsAll82Phase 4France;Germany;Hungary;Netherlands
230EUCTR2006-002748-27-FR01/12/200619/12/2006A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing SpondylitisA Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis Active, severe and advanced axial ankylosing spondylitis.Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Wyeth Pharmaceuticals FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Hungary;Germany;Netherlands;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2004-003299-12-GB11/10/200624/01/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
345Phase 3Finland;Belgium;Germany;United Kingdom
232EUCTR2004-003299-12-FI26/04/200628/12/2005A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
233EUCTR2004-003299-12-DE04/04/200602/01/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Janssen Biologics B.V.NULLNot RecruitingFemale: yes
Male: yes
345Finland;United Kingdom;Germany;Belgium
234EUCTR2004-003299-12-BE20/03/200601/02/2006A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NAA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis - NA Ankylosing Spondylitis (AS)Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
345Phase 3Finland;Belgium;Germany;United Kingdom
235NCT00265083December 200512/12/2005A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing SpondylitisA Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing SpondylitisSpondylitis, AnkylosingBiological: golimumab;Biological: Golimumab (CNTO 148); placeboCentocor, Inc.Schering-PloughCompleted18 YearsN/AAll356Phase 3United States;Belgium;Canada;Finland;France;Germany;Korea, Republic of;Netherlands;Taiwan;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
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PhaseCountries
236NCT00202865May 1, 200516/9/2005Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)CANaDian Evaluation of Low DosE Infliximab in Ankylosing SpondylitisSpondylitis, AnkylosingBiological: infliximab;Biological: PlaceboMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll76Phase 3Canada
237NCT00235105March 20056/10/2005D2E7-Early ASAdalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension PhaseAnkylosing SpondylitisDrug: Adalimumab 40 mg sc every other weekCharite University, Berlin, GermanyAbbottActive, not recruiting18 YearsN/ABoth46Phase 2/Phase 3Germany
238NCT00418548June 20044/1/2007Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing SpondylitisA Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing SpondylitisAnkylosing SpondylitisDrug: EtanerceptWyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth350Phase 3NULL
239NCT00085644January 200410/6/2004Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisA Phase 3 Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNULLCompleted18 YearsN/AAll315Phase 3United States
240NCT00195819December 200316/9/2005Safety and Efficacy of Adalimumab in Patients With Active Ankylosing SpondylitisA Phase 3, Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing SpondylitisAnkylosing SpondylitisBiological: adalimumab (D2E7);Biological: placeboAbbottNULLCompleted18 YearsN/AAll82Phase 3Canada;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
241NCT00207701September 200213/9/2005A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug TherapyAnkylosing SpondylitisDrug: infliximabCentocor, Inc.Centocor BV, NetherlandsCompleted18 YearsN/ABoth279Phase 3NULL
242NCT00244166May 200225/10/2005Prednisolone in Active Ankylosing Spondylitis (AS)Threecenter Placebo Controlled Three Arm Trial in Patients With Active Ankylosing Spondylitis With PrednisoloneAnkylosing SpondylitisDrug: prednisoloneCharite University, Berlin, GermanyNULLRecruiting18 Years70 YearsBoth75Phase 2/Phase 3Germany
243NCT00421915March 20028/1/2007Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisMulticenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final DataAnkylosing SpondylitisDrug: Enbrel (etanercept)Wyeth is now a wholly owned subsidiary of PfizerNULLCompleted18 Years70 YearsBoth84Phase 3NULL