| 1 |
NCT03350815 |
Recruiting |
Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis |
|
- Drug: 150 mg open-label secukinumab
- Drug: 150 mg double-blinded secukinumab
- Drug: 300 mg double-blinded secukinumab
|
Interventional
|
Phase 4 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The proportion of participants who achieve inactive disease based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) measure
- The proportion of participants who achieve a clinically important improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) scale
- Change over time in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- (and 7 more...)
|
270 |
All |
18 Years and older (Adult, Older Adult) |
NCT03350815 |
CAIN457FUS06 |
ASLeap |
March 13, 2018 |
May 12, 2020 |
May 12, 2020 |
November 22, 2017 |
January 9, 2019 |
|
- Novartis Investigative Site
Jonesboro, Arkansas, United States - Novartis Investigative Site
Fullerton, California, United States - Novartis Investigative Site
Huntington Beach, California, United States - (and 41 more...)
|
|
| 2 |
NCT03800797 |
Completed |
Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis |
|
- Drug: Loxoprofen sodium hydrogel patch
- Drug: Loxoprofen sodium tablet
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
- ASAS5/6 response
- ASAS20 response
|
70 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03800797 |
[2014]2-135 |
|
May 25, 2015 |
December 10, 2015 |
December 10, 2015 |
January 11, 2019 |
January 11, 2019 |
|
- Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
|
|
| 3 |
NCT03457285 |
Recruiting |
Investigating the Use of Salaso to Improve Physiotherapy Management of Ankylosing Spondylitis (AS). |
|
|
Interventional
|
Not Applicable |
- St. James's Hospital, Ireland
- Salaso Health Solutions Limited
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bath Ankylosing Spondylitis Metrology Index
- Bath Ankylosing Spondylitis Disease Activity Index
- Bath Ankylosing Spondylitis Functional Index
- (and 2 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT03457285 |
SJH AS Salaso Study |
|
October 17, 2018 |
April 17, 2019 |
May 31, 2019 |
March 7, 2018 |
November 7, 2018 |
|
- Physiotherapy Department, Saint James's Hospital
Dublin, Ireland
|
|
| 4 |
NCT02333383 |
Completed
Has Results |
Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Frequency of Extra-Axial Manifestations (EAMs) of Interest
- Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
- Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline
- (and 4 more...)
|
201 |
All |
19 Years to 100 Years (Adult, Older Adult) |
NCT02333383 |
P15-238 |
AS PMOS |
December 31, 2014 |
August 8, 2017 |
August 8, 2017 |
January 7, 2015 |
January 15, 2019 |
January 15, 2019 |
|
|
| 5 |
NCT00667355 |
Completed
Has Results |
A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12
- Number of Subjects Achieving ASAS 20
- Number of Subjects Achieving ASAS 50
- (and 16 more...)
|
41 |
All |
15 Years and older (Child, Adult, Older Adult) |
NCT00667355 |
M10-239 |
|
February 2008 |
May 2009 |
January 2011 |
April 28, 2008 |
January 26, 2012 |
August 11, 2010 |
- Site Reference # / Investigator 46791
Aichi, Japan - Site Reference # / Investigator 46789
Fukui, Japan - Site Reference # / Investigator 46798
Fukuoka, Japan - (and 16 more...)
|
|
| 6 |
NCT03140657 |
Completed |
The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis Patients |
|
- Drug: Nanocurcumin
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Tabriz University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Assessments of Ankylosing Spondylitis Signs and Symptoms (BASDI)
- mir-141, mir-155 and mir-200 expression
- Serum IL-17 levels
- (and 8 more...)
|
24 |
All |
23 Years to 46 Years (Adult) |
NCT03140657 |
TabrizUMS-Rheumatology-003 |
|
April 29, 2017 |
November 7, 2017 |
January 18, 2018 |
May 4, 2017 |
September 17, 2018 |
|
- Connective Tissue Diseases Research Center
Tabriz, Iran, Islamic Republic of
|
|
| 7 |
NCT01079182 |
Completed
Has Results |
Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS) |
|
|
Observational
|
|
- AbbVie (prior sponsor, Abbott)
- AbbVie
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
- Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
- Number of Participants With Drug-Related Adverse Events (AEs)
- (and 21 more...)
|
4681 |
All |
18 Years and older (Adult, Older Adult) |
NCT01079182 |
P10-147 |
|
January 2006 |
May 2014 |
May 2014 |
March 3, 2010 |
July 9, 2015 |
June 1, 2015 |
|
|
| 8 |
NCT02201043 |
Completed |
Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis |
|
- Drug: Thalidomide 150mg
- Drug: Thalidomide 100mg
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Shanghai Pharmaceuticals Holding Co., Ltd
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
- Change of ASDAS score
- Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- (and 11 more...)
|
197 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02201043 |
SLDA-201 |
|
February 2013 |
February 2015 |
February 2015 |
July 25, 2014 |
November 20, 2015 |
|
- The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China - The General Hospital of People's Liberation Army
BeiJing, Beijing, China - Zhongshan Hospital Fudan University
Shanghai, Shanghai, China - (and 6 more...)
|
|
| 9 |
NCT00247962 |
Completed
Has Results |
Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis |
|
- Drug: etanercept
- Drug: sulphasalazine (SSZ)
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
- Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
|
566 |
All |
18 Years and older (Adult, Older Adult) |
NCT00247962 |
0881A3-402 |
|
December 2005 |
February 2008 |
February 2008 |
November 2, 2005 |
November 8, 2012 |
November 8, 2012 |
- Heidelberg West, Victoria, Australia
- Shenton Park, Western Australia, Australia
- Innsbruck, Austria
- (and 80 more...)
|
|
| 10 |
NCT03505892 |
Recruiting |
A Study to Investigate the Clinical REsponses in Ankylosing Spondylitis Patients on Adalimumab Therapy in Taiwan (EAST) |
- Ankylosing Spondylitis (AS)
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of participants that achieve 50% improvement of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
- Percentages of participants who achieve major improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24
- Percentages of participants who achieve clinically important improvement of Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24
- (and 11 more...)
|
140 |
All |
18 Years and older (Adult, Older Adult) |
NCT03505892 |
P16-326 |
EAST |
June 5, 2018 |
March 14, 2020 |
March 14, 2020 |
April 23, 2018 |
October 25, 2018 |
|
- Hualien Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
Hualien City, Taiwan
|
|
| 11 |
NCT01248793 |
Completed
Has Results |
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis |
|
- Drug: Placebo
- Drug: Golimumab
- Drug: Golimumab (placebo group)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14
- Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24
- Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
- Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14
|
213 |
All |
18 Years and older (Adult, Older Adult) |
NCT01248793 |
CR015916
C0524T29 |
|
October 2010 |
May 2011 |
March 2012 |
November 25, 2010 |
March 20, 2013 |
June 28, 2012 |
- Beijing, China
- Chengdu, China
- Guangzhou, China
- (and 4 more...)
|
|
| 12 |
NCT00873730 |
Completed
Has Results |
Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain |
|
- Drug: etanercept
- Drug: etanercept/placebo
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.
- (and 13 more...)
|
108 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00873730 |
0881A3-406 |
Loadet |
December 2006 |
June 2008 |
June 2008 |
April 2, 2009 |
April 28, 2010 |
August 13, 2009 |
|
|
| 13 |
NCT01754727 |
Completed
Has Results |
Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice |
|
|
Observational
|
|
- AbbVie (prior sponsor, Abbott)
- AbbVie
|
Industry |
- Time Perspective: Prospective
|
- Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
- Percentage of Participants Achieving BASDAI 50
- Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline
- (and 8 more...)
|
452 |
All |
18 Years and older (Adult, Older Adult) |
NCT01754727 |
P13-682 |
IDEA |
December 2012 |
October 2015 |
October 2015 |
December 21, 2012 |
March 6, 2017 |
March 6, 2017 |
|
|
| 14 |
NCT00809159 |
Completed
Has Results |
Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis |
|
- Biological: AIN457
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
|
- Percentage of Participants Who Achieved ASAS20 Response
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2
- Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1
- (and 20 more...)
|
60 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00809159 |
CAIN457A2209
2008-002631-33 |
|
March 2009 |
May 2011 |
May 2011 |
December 17, 2008 |
December 9, 2015 |
September 18, 2015 |
- Novartis Investigative Site
Paradise Valley, Arizona, United States - Novartis Investigative Site
Springfield, Illinois, United States - Novartis Investigative Site
Springfield, Illinois, United States - (and 17 more...)
|
|
| 15 |
NCT03726645 |
Enrolling by invitation |
The Effect of Fecal Microbiota Transplantation in Ankylosing Spondylitis (AS) Patients. |
|
- Other: Fecal microbiota transplantation
|
Interventional
|
Early Phase 1 |
- Hospital District of Helsinki and Uusimaa
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The effect of FMT (fecal microbiota transplantation) on the clinical activity of ankylosing spondylitis (AS) as assessed by change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index).
- The effect of FMT on the clinical activity of AS as assessed by change in BASFI (Bath Ankylosing Spondylitis Functional Index).
- The effect of FMT on the clinical activity of AS as assessed by change in MASES (Maastricht Ankylosing Spondylitis Enthesitis Score).
- (and 15 more...)
|
20 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03726645 |
HospitalDHU/Rheumatology |
ASGUT |
October 24, 2018 |
April 2020 |
April 2020 |
October 31, 2018 |
October 31, 2018 |
|
- Hospital District of Helsinki and Uusimaa, Department of Rheumatology
Helsinki, Uusimaa, Finland
|
|
| 16 |
NCT03502616 |
Recruiting |
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assessment in Ankylosing Spondylitis (ASAS) 20 response
- Assessment in Ankylosing Spondylitis (ASAS) 40 response
- Change from Baseline in Ankylosing Spondylitis Disease Activity Score using C-Reactive Protein
- (and 20 more...)
|
240 |
All |
18 Years and older (Adult, Older Adult) |
NCT03502616 |
A3921120
AS
2018-000226-58 |
|
June 7, 2018 |
August 2, 2020 |
August 2, 2020 |
April 18, 2018 |
February 5, 2019 |
|
- Arizona Arthritis & Rheumatology Associates, P.C.
Gilbert, Arizona, United States - Medvin Clinical Research
Covina, California, United States - University of California, San Francisco Medical Center
San Francisco, California, United States - (and 91 more...)
|
|
| 17 |
NCT01289743 |
Unknown † |
Etanercept (Enbrel) in Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2 |
- Charite University, Berlin, Germany
- Rheumazentrum Ruhrgebiet
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response
- Sustained response
- Safety outcome
- (and 2 more...)
|
24 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01289743 |
Enbrel _AS-2
202-04 |
Enbrel_AS-2 |
February 2002 |
September 2003 |
May 2012 |
February 4, 2011 |
February 4, 2011 |
|
- Charite Campus Benjamin Franklin, Rheumatology
Berlin, Germany - Rheumazentrum Ruhrgebiet
Herne, Germany
|
|
| 18 |
NCT03259074 |
Recruiting |
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) |
|
- Biological: Secukinumab
- Biological: GP2017 (adalimumab biosimilar)
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
- Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
- No new syndesmophytes as measured by mSASSS
- (and 6 more...)
|
837 |
All |
18 Years and older (Adult, Older Adult) |
NCT03259074 |
CAIN457K2340 |
SURPASS |
July 10, 2017 |
September 2, 2021 |
January 20, 2022 |
August 23, 2017 |
January 9, 2019 |
|
- Novartis Investigative Site
Mesa, Arizona, United States - Novartis Investigative Site
Paradise Valley, Arizona, United States - Novartis Investigative Site
Escondido, California, United States - (and 163 more...)
|
|
| 19 |
NCT03447704 |
Recruiting |
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis |
|
- Drug: BCD-085
- Other: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- ASAS40 rate at Week 16
- ASAS20 rate
- Change from baseline in BASDAI
- (and 3 more...)
|
228 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03447704 |
BCD-085-5 |
|
February 8, 2018 |
January 2019 |
February 2020 |
February 27, 2018 |
March 7, 2018 |
|
- Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
Chelyabinsk, Russian Federation - Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russian Federation - Kazan State Medical University
Kazan, Russian Federation - (and 4 more...)
|
|
| 20 |
NCT02758782 |
Active, not recruiting |
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis |
|
- Biological: Golimumab
- Drug: Celecoxib
|
Interventional
|
Phase 4 |
- Charite University, Berlin, Germany
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial
- New syndesmophyte formation or progression of existing syndesmophytes
- Improvement of disease activity (BASDAI)
- (and 7 more...)
|
156 |
All |
18 Years and older (Adult, Older Adult) |
NCT02758782 |
CONSUL2016 |
CONSUL |
September 2016 |
December 2020 |
December 2020 |
May 2, 2016 |
December 19, 2018 |
|
- Rheumapraxis Kupka
Altenburg, Germany - Rheumapraxis Bayreuth Dr. Ochs
Bayreuth, Germany - Charite Universitaetsmedizin - Dpt. Rheumatology at Campus Charite Mitte
Berlin, Germany - (and 16 more...)
|
|
| 21 |
NCT01286545 |
Unknown † |
European Ankylosing Spondylitis Infliximab Cohort (EASIC) Follow up Registration Study |
|
|
Observational
|
|
- Rheumazentrum Ruhrgebiet
- Centocor Ortho Biotech Services, L.L.C.
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
100 |
All |
18 Years to 95 Years (Adult, Older Adult) |
NCT01286545 |
EASIC 30505 registry |
EASIC registry |
February 2011 |
July 2013 |
October 2013 |
January 31, 2011 |
January 31, 2011 |
|
- Erasme University Hospital
Brussels, Belgium - Universitair Ziekenhuis, Afdeling Rheumatologie
Gent, Belgium - University Hospital Leuven
Leuven, Belgium - (and 16 more...)
|
|
| 22 |
NCT01474876 |
Completed
Has Results |
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis |
- Ankylosing Spondylitis
- Psoriatic Arthritis
|
|
Observational
|
|
- AbbVie (prior sponsor, Abbott)
- AbbVie
|
Industry |
- Time Perspective: Prospective
|
- Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline
- Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline
- Percentage of Participants With Active Axial Symptoms in Remission
- (and 17 more...)
|
566 |
All |
18 Years and older (Adult, Older Adult) |
NCT01474876 |
P12-768 |
|
November 2011 |
May 2014 |
May 2014 |
November 18, 2011 |
July 8, 2015 |
July 8, 2015 |
|
|
| 23 |
NCT01895764 |
Completed |
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS) |
|
- Drug: Adalimumab
- Drug: Methotrexate
|
Interventional
|
Phase 4 |
- University Hospital, Tours
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- presence or absence of antibodies against adalimumab
- Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)
- Change from baseline of T and B cells concentrations.
- Change from baseline of "APRIL" and "TNF alpha" concentrations
|
110 |
All |
18 Years and older (Adult, Older Adult) |
NCT01895764 |
PHRI12-ED-COMARIS
2012-004939-23
A130042-32
2012-R41 |
COMARIS |
March 2013 |
April 2015 |
April 2015 |
July 10, 2013 |
September 29, 2015 |
|
- Rhumatologie, CH de BLOIS
Blois, France - Rhumatologie, CHRU de BREST
Brest, France - Rhumatologie, CHD LA ROCHE SUR YON
La Roche Sur Yon, France - (and 8 more...)
|
|
| 24 |
NCT03117270 |
Completed |
A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis |
|
- Drug: filgotinib
- Drug: Placebo Oral Tablet
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo
- Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo
- Assessment by a trained joint assessor of 44 joints for tenderness (counting the number or tender joints - TJC) and swelling (counting the number of swollen joints - SJC) in filgotinib treated subjects as compared to placebo
- (and 14 more...)
|
116 |
All |
18 Years and older (Adult, Older Adult) |
NCT03117270 |
GLPG0634-CL-223 |
TORTUGA |
March 7, 2017 |
July 2, 2018 |
July 2, 2018 |
April 17, 2017 |
August 13, 2018 |
|
- ULB Hopital Erasme, Service de Rheumatology
Brussels, Belgium - Eurohospital
Plovdiv, Bulgaria - UMHAT Kaspela EOOD
Plovdiv, Bulgaria - (and 27 more...)
|
|
| 25 |
NCT01329380 |
Completed |
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation) |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Bath ankylosing spondylitis Disease Activity Index
- Number of patients with adverse events
- Effectiveness evaluation by the investigator
|
401 |
All |
16 Years to 99 Years (Child, Adult, Older Adult) |
NCT01329380 |
P12-764 |
|
November 29, 2010 |
December 31, 2017 |
December 31, 2017 |
April 5, 2011 |
January 26, 2018 |
|
- Nagoya City University Hospital
Nagoya-shi, Aichi, Japan - Kurume University Hospital
Kurume-shi, Fukuoka, Japan - Gunma University Hospital
Maebashi-shi, Gunma, Japan - (and 191 more...)
|
|
| 26 |
NCT03215277 |
Recruiting |
Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis. |
|
- Drug: Bimekizumab
- Drug: Certolizumab Pegol
- Other: Placebo
|
Interventional
|
Phase 2 |
- UCB Biopharma S.P.R.L.
- UCB Pharma
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
- Incidence of Adverse Events (AE) during the study conduct
- Incidence of Serious Adverse Events (SAEs) during the study conduct
- (and 5 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03215277 |
AS0013
2017-000957-37 |
|
October 4, 2017 |
June 2019 |
June 2020 |
July 12, 2017 |
February 15, 2019 |
|
- As0013 908
Ormond Beach, Florida, United States - As0013 901
Tampa, Florida, United States - As0013 903
Lincoln, Nebraska, United States - (and 36 more...)
|
|
| 27 |
NCT02763111 |
Completed |
Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis |
|
- Drug: BCD-085
- Other: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Ratio of patients with ASAS20 response after 16 weeks of therapy
- Ratio of patients with ASAS20 response after 4, 8, 12 weeks of therapy
- Ratio of patients with ASAS40 response after 4, 8, 12, 16 weeks of therapy
- (and 24 more...)
|
88 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02763111 |
BCD-085-3 |
|
September 2016 |
June 2017 |
June 2017 |
May 5, 2016 |
February 21, 2018 |
|
|
|
| 28 |
NCT03807180 |
Not yet recruiting |
Effects of Tai Chi in Patients With Ankylosing Spondylitis Receiving Anti-TNF Alpha Therapy |
|
- Other: Tai Chi (exercise)
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Other
|
- Bath Ankylosing Spondylitis Functional Index (BASFI)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- Bath Ankylosing Spondylitis Metrology Index (BASMI)
- (and 2 more...)
|
36 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03807180 |
60116787-020/55441 |
|
January 25, 2019 |
April 30, 2019 |
June 15, 2019 |
January 16, 2019 |
January 25, 2019 |
|
|
|
| 29 |
NCT00195819 |
Completed
Has Results |
Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis |
|
- Biological: adalimumab (D2E7)
- Biological: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12
- Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score
- Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure
- (and 41 more...)
|
82 |
All |
18 Years and older (Adult, Older Adult) |
NCT00195819 |
M03-606 |
|
December 2003 |
October 2004 |
June 2009 |
September 20, 2005 |
June 28, 2011 |
April 28, 2010 |
- Site Ref # / Investigator 74
Calgary, Alberta, Canada - Site Ref # / Investigator 70
Edmonton, Alberta, Canada - Site Ref # / Investigator 79
Vancouver, British Columbia, Canada - (and 6 more...)
|
|
| 30 |
NCT01114880 |
Completed
Has Results |
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis |
|
- Biological: adalimumab
- Other: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria
- Number of Participants Meeting the ASAS20 Response Criteria
- Number of Participants Meeting the ASAS40 Response Criteria
- (and 9 more...)
|
344 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01114880 |
M11-991 |
|
January 2010 |
September 2010 |
February 2011 |
May 3, 2010 |
December 1, 2011 |
November 4, 2011 |
- Site Reference ID/Investigator# 24054
Hefei, Anhui, China - Site Reference ID/Investigator# 25522
Beijing, China - Site Reference ID/Investigator# 24055
Beijing, China - (and 6 more...)
|
|
| 31 |
NCT03355573 |
Active, not recruiting |
A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2 |
- UCB Biopharma S.P.R.L.
- UCB Pharma
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Adverse Event (AE) during the study
- Incidence of Serious Adverse Event (SAE) during the study
- Subjects who withdrew due to an Adverse Event (AE) during the study
- (and 4 more...)
|
256 |
All |
18 Years and older (Adult, Older Adult) |
NCT03355573 |
AS0009
2017-001002-15 |
|
November 28, 2017 |
December 2022 |
December 2022 |
November 28, 2017 |
October 26, 2018 |
|
- As0009 030
Sarasota, Florida, United States - As0009 001
Duncansville, Pennsylvania, United States - As0009 006
Dallas, Texas, United States - (and 47 more...)
|
|
| 32 |
NCT00420238 |
Completed
Has Results |
Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis |
|
- Drug: Etanercept (Enbrel)
- Other: Placebo
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12
- Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
- Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12
- (and 62 more...)
|
82 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00420238 |
0881A3-403 |
|
January 2007 |
February 2009 |
May 2009 |
January 11, 2007 |
June 29, 2010 |
June 15, 2010 |
- Amiens, France
- Arles, France
- Avignon, France
- (and 18 more...)
|
|
| 33 |
NCT01077843 |
Completed |
Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163) |
|
- Drug: Etoricoxib
- Drug: Other Cox-2 inhibitors
- Drug: Other Non-selective NSAIDs
- Other: No anti-inflammatory treatment
|
Observational
|
|
- Merck Sharp & Dohme Corp.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Incidence rate of gastrointestinal ulcer, perforation or bleeding
- Incidence rate of fatal or non-fatal acute myocardial infarction or unstable angina pectoris
- Incidence rate of fatal or non-fatal ischemic stroke, or transient ischemic attack
- (and 6 more...)
|
27381 |
All |
Child, Adult, Older Adult |
NCT01077843 |
0663-163 |
|
August 17, 2009 |
July 1, 2015 |
July 1, 2015 |
March 1, 2010 |
June 7, 2017 |
|
|
|
| 34 |
NCT02525042 |
Completed |
Genetic Susceptibility to Ankylosing Spondylitis (AS) by Functional Genomics Approach |
|
|
Observational
|
|
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Observational Model: Family-Based
- Time Perspective: Retrospective
|
- Comparison of the transcriptome of dendritic cells derived from circulating monocytes between cases and controls
- Assessment of manifestations of Ankylosing Spondylitis (AS) according an Updating Questionnaire.
|
97 |
All |
18 Years and older (Adult, Older Adult) |
NCT02525042 |
NI09031 |
GENOSPA |
August 2011 |
January 2014 |
|
August 17, 2015 |
August 17, 2015 |
|
- Ambroise Paré Hospital
Boulogne-Billancourt, Hauts-De-Seine, France
|
|
| 35 |
NCT01690273 |
Completed
Has Results |
Exercise Therapy Program in Ankylosing Spondylitis Patients |
|
- Other: mobility exercise
- Other: mobility and elastic resistance exercise
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- FUNCTIONAL INDEX
- Mobility Index
- Disease Activity Index
- (and 12 more...)
|
55 |
All |
Child, Adult, Older Adult |
NCT01690273 |
8206212 |
|
July 2012 |
June 2013 |
November 2014 |
September 21, 2012 |
October 20, 2016 |
October 20, 2016 |
- University of Sao Paulo
Sao Paulo, Brazil
|
|
| 36 |
NCT02456363 |
Recruiting |
Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis |
|
- Biological: TNF alpha
- Drug: NSAIDs and sulfasalazine
|
Interventional
|
Phase 2 |
- Chung Shan Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT02456363 |
CS09128 |
|
November 2009 |
October 2019 |
December 2019 |
May 28, 2015 |
May 28, 2015 |
|
- Chung Shan Medical University Hospital
Taichung, Taiwan
|
|
| 37 |
NCT02284646 |
Unknown † |
Physical Training Program in Ankylosing Spondylitis |
|
- Other: Personalized physical training program
|
Interventional
|
Not Applicable |
- University Hospital, Toulouse
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of patients reaching an ASAS 20 response
|
56 |
All |
18 Years to 60 Years (Adult) |
NCT02284646 |
13 7027 08 |
PEPS |
November 2014 |
October 2017 |
November 2017 |
November 6, 2014 |
February 23, 2017 |
|
- University Hospital
Toulouse, France
|
|
| 38 |
NCT02528201 |
Completed |
A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis |
|
- Drug: Celecoxib 200 milligrams
- Drug: Celecoxib 400 milligrams
- Drug: diclofenac 50 milligrams
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in baseline of Patient Global Assessment of Pain Intensity (VAS) at week 12
- Participants Global Assessment of Pain Intensity (VAS)
- Bath Ankylosing Spondylitis Functional Index (BASFI)
- (and 4 more...)
|
330 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02528201 |
COXA-0508-247
A3191099 |
|
September 2002 |
November 2004 |
November 2004 |
August 19, 2015 |
August 19, 2015 |
|
- Bekkestua legesenter
Bekkestua, Norway - Dr. Johannessen Kontor
Bergen, Norway - Dr.Wiigs kontor
Bergen, Norway - (and 24 more...)
|
|
| 39 |
NCT01351311 |
Completed |
Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis |
|
- Other: Exercise
- Other: Drug treatment
|
Interventional
|
Not Applicable |
- Federal University of São Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Bath Ankylosing Spondylitis Functional Index (BASFI)
- LIKERT SCALE
- 1 REPETITION MAXIMUM TEST
- (and 8 more...)
|
60 |
All |
18 Years to 60 Years (Adult) |
NCT01351311 |
FDAAAMC |
|
March 2011 |
November 2012 |
November 2012 |
May 10, 2011 |
November 30, 2012 |
|
- Marcelo Cardoso de Souza
Sao Paulo, Brazil
|
|
| 40 |
NCT02963506 |
Completed |
A Multicenter Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis |
|
- Other: Placebo
- Drug: Bimekizumab
|
Interventional
|
Phase 2 |
- UCB Biopharma S.P.R.L.
- UCB Pharma
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 12
- Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
- Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12
- (and 6 more...)
|
303 |
All |
18 Years and older (Adult, Older Adult) |
NCT02963506 |
AS0008
2016-001102-42 |
|
October 2016 |
October 2017 |
August 2018 |
November 15, 2016 |
October 23, 2018 |
|
- As0008 019
Anniston, Alabama, United States - As0008 007
La Jolla, California, United States - As0008 009
Upland, California, United States - (and 71 more...)
|
|
| 41 |
NCT01061723 |
Completed
Has Results |
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis |
|
- Drug: Sarilumab
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12
- Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12
- Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12
- (and 9 more...)
|
301 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01061723 |
DRI11073
2009-016068-35 |
ALIGN |
February 2010 |
June 2011 |
June 2011 |
February 3, 2010 |
August 8, 2017 |
August 8, 2017 |
- Investigational Site Number 840006
Birmingham, Alabama, United States - Investigational Site Number 840033
Anaheim, California, United States - Investigational Site Number 840027
Los Angeles, California, United States - (and 77 more...)
|
|
| 42 |
NCT01856569 |
Completed
Has Results |
Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Other
|
- Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18
- Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity
- (and 3 more...)
|
152 |
All |
18 Years and older (Adult, Older Adult) |
NCT01856569 |
B1801362 |
ASSIAL |
July 2013 |
October 2015 |
November 2015 |
May 17, 2013 |
March 9, 2017 |
March 9, 2017 |
- Unita Operativa Semplice di Reumatologia
Catania, CT, Italy - U.O.S. Reumatologia - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola-Malpighi
Bologna, Italy - Piazzale Spedali Civili
Brescia, Italy - (and 15 more...)
|
|
| 43 |
NCT01786668 |
Completed
Has Results |
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis |
|
- Drug: Tofacitinib 2 mg
- Drug: Tofacitinib 5 mg
- Drug: Tofacitinib 10 mg
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
- Percentage of Participants Achieving ASAS20 at Week 12
- Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8
- (and 20 more...)
|
208 |
All |
18 Years and older (Adult, Older Adult) |
NCT01786668 |
A3921119
2011-005689-39 |
|
April 2013 |
March 2015 |
March 2015 |
February 8, 2013 |
June 10, 2016 |
June 10, 2016 |
- Desert Medical Imaging
Indian Wells, California, United States - Desert Medical Advances
Palm Desert, California, United States - Arthritis & Rheumatology Associates
Clearwater, Florida, United States - (and 64 more...)
|
|
| 44 |
NCT00900796 |
Completed
Has Results |
Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis |
|
- Other: Treatment switching
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Participants With a Clinical Response
- Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment
- Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment
- (and 4 more...)
|
132 |
All |
18 Years and older (Adult, Older Adult) |
NCT00900796 |
0881A3-4452
B1801100 |
PRETEA |
March 2009 |
May 2011 |
May 2011 |
May 13, 2009 |
June 19, 2012 |
June 19, 2012 |
- Pfizer Investigational Site
Madrid, Spain
|
|
| 45 |
NCT01567878 |
Completed |
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects |
|
|
Observational
|
|
|
Other |
|
- Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects
|
80 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01567878 |
1649/09 |
|
May 2009 |
December 2014 |
December 2014 |
March 30, 2012 |
December 2, 2014 |
|
- Suellen Narimatsu
Sao Paulo, Brazil
|
|
| 46 |
NCT02186873 |
Completed
Has Results |
A Study of Golimumab in Participants With Active Ankylosing Spondylitis |
|
- Drug: Placebo
- Drug: Golimumab
|
Interventional
|
Phase 3 |
- Janssen Research & Development, LLC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
- Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
- Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
- (and 6 more...)
|
208 |
All |
18 Years and older (Adult, Older Adult) |
NCT02186873 |
CR103795
CNTO148AKS3001
2014-000241-74 |
|
September 3, 2014 |
December 15, 2015 |
October 11, 2016 |
July 10, 2014 |
December 22, 2017 |
November 13, 2017 |
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- La Palma, California, United States
- (and 44 more...)
|
|
| 47 |
NCT01118728 |
Terminated
Has Results |
Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation
- Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)
|
223 |
All |
18 Years and older (Adult, Older Adult) |
NCT01118728 |
LTS11298
2010-019263-11 |
SUSTAIN |
June 2010 |
December 2011 |
December 2011 |
May 7, 2010 |
June 21, 2017 |
June 21, 2017 |
- Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States - Sanofi-Aventis Administrative Office
Macquarie Park, New South Wales, Australia - Sanofi-Aventis Administrative Office
Wien, Austria - (and 9 more...)
|
|
| 48 |
NCT01668004 |
Completed
Has Results |
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) |
|
|
Interventional
|
Phase 4 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
- Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
- Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment
- (and 2 more...)
|
101 |
All |
18 Years and older (Adult, Older Adult) |
NCT01668004 |
8259-012
2012-002458-21 |
GO-EASY |
September 3, 2012 |
April 30, 2015 |
April 30, 2015 |
August 17, 2012 |
February 4, 2019 |
August 3, 2016 |
|
|
| 49 |
NCT01709656 |
Completed |
A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis |
|
- Biological: MSC
- Drug: "celecoxib", "Celebrex®"
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- the proportion of patients which disease activity reaches ASAS(assessment in ankylosing Spondylitis)20 remission criteria
- BASDAI score comparing to baseline
- BASFI score comparing to baseline
|
120 |
All |
16 Years to 65 Years (Child, Adult, Older Adult) |
NCT01709656 |
[2012]2-31 |
|
March 2012 |
December 2014 |
December 2014 |
October 18, 2012 |
February 11, 2015 |
|
- Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
|
|
| 50 |
NCT01421303 |
Completed
Has Results |
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline
- Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6
- Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12
- (and 19 more...)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT01421303 |
0881A3-4675
B1801053 |
AS@WORK |
October 2009 |
December 2013 |
December 2013 |
August 22, 2011 |
December 12, 2014 |
December 12, 2014 |
- Universitair Ziekenhuis Gent
Gent, Belgium
|
|
| 51 |
NCT02762812 |
Completed |
Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis |
|
- Biological: BCD-055
- Biological: Remicade®
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Ratio of patients with ASAS20 response after 30 weeks of therapy
- Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy
- Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy
- (and 9 more...)
|
199 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02762812 |
BCD-055-2 |
|
January 2016 |
May 2017 |
July 2017 |
May 5, 2016 |
February 23, 2018 |
|
- North-Western State Medical University n.a. I.I.Mechnikov
St.Petersburg, Russian Federation
|
|
| 52 |
NCT02750592 |
Completed |
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis |
|
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assessment of SpondyloArthritis International Society criteria (ASAS) 20 response
- ASAS 40 response
- Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50
- (and 9 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02750592 |
CAIN457H1301 |
|
March 22, 2016 |
July 5, 2017 |
May 16, 2018 |
April 25, 2016 |
September 24, 2018 |
|
- Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan - Novartis Investigative Site
Kita-gun, Kagawa, Japan - Novartis Investigative Site
Nankoku city, Kochi, Japan - (and 7 more...)
|
|
| 53 |
NCT01387802 |
Active, not recruiting |
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis |
|
|
Observational
|
|
- AbbVie (prior sponsor, Abbott)
- JSS Medical Research Inc.
- Cato Research
- AbbVie
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis
- Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis
- Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease
- (and 4 more...)
|
722 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01387802 |
P12-672 |
Complete-AS |
June 29, 2011 |
November 30, 2019 |
November 30, 2019 |
July 6, 2011 |
November 5, 2018 |
|
- Rheumatology Clinic /ID# 54768
Calgary, Alberta, Canada - Associate Clinic /ID# 64274
Calgary, Alberta, Canada - Pont, Cranbrook, BC, CA /ID# 55242
Cranbrook, British Columbia, Canada - (and 53 more...)
|
|
| 54 |
NCT01330901 |
Completed |
Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2 |
- Charite University, Berlin, Germany
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Assessment of Spondyloarthritis International Society (ASAS)40 response
- The Assessment of Spondyloarthritis International Society (ASAS)20 response at week 24
- The Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement
- (and 3 more...)
|
22 |
All |
18 Years and older (Adult, Older Adult) |
NCT01330901 |
TOPAS |
TOPAS |
October 2011 |
April 2013 |
May 2013 |
April 7, 2011 |
June 4, 2013 |
|
- Department of Rheumatology, Charité - Campus Benjamin Franklin
Berlin, Germany
|
|
| 55 |
NCT02557308 |
Recruiting |
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Detection of events of special interest in AS patients
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- Bath Ankylosing Spondylitis Functional Index (BASFI)
- Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS) Physician and Patient Global Assessment of Disease Status
|
1000 |
All |
18 Years and older (Adult, Older Adult) |
NCT02557308 |
CT-P13 4.4 |
|
August 2014 |
June 2020 |
June 2026 |
September 23, 2015 |
July 24, 2018 |
|
- TaeHwan Kim
Seoul, Korea, Republic of
|
|
| 56 |
NCT02389075 |
Recruiting |
The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis |
- Inflammatory Bowel Diseases (IBD)
- Ankylosing Spondylitis (AS)
|
- Procedure: Pinch biopsies
- Procedure: Flexible sigmoidoscopy
|
Observational
|
|
- University of Colorado, Denver
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- IEL characteristics in IBD, AS, and healthy controls
- Microbiome Differences in IBD, AS, and healthy controls
- Microbiome changes are reflected in IELs
|
60 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02389075 |
14-1507
UL1TR001082 |
|
March 2015 |
June 2019 |
June 2019 |
March 17, 2015 |
July 25, 2018 |
|
- Denver, Colorado, United States
|
|
| 57 |
NCT03557853 |
Active, not recruiting |
Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab |
- Ankylosing Spondylitis
- Coxitis
|
- Drug: Golimumab Injection
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change of BASFI (Bath Ankylosing Spodylitis Functionality Index)
- Change of BASMI (Bath Ankylosing Spodylitis Mobility Index)
- Change of ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)
- (and 2 more...)
|
39 |
All |
18 Years and older (Adult, Older Adult) |
NCT03557853 |
MK-8259-021 |
GO-COX |
June 2016 |
June 2019 |
September 2020 |
June 15, 2018 |
June 21, 2018 |
|
- KhMAO Regional Clinical Hospital
Khanty-Mansiysk, Russian Federation - Moscow Clinical Scientific Center
Moscow, Russian Federation - Pirogov National Medical Surgical Center
Moscow, Russian Federation - (and 3 more...)
|
|
| 58 |
NCT01850121 |
Completed |
Remicade in the Treatment of Patients With Active Ankylosing Spondylitis |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Bath AS disease activity score (BASDAI)
|
19 |
All |
18 Years to 60 Years (Adult) |
NCT01850121 |
2002-11-04 amended 2002-01-08 |
|
January 2003 |
May 2008 |
May 2008 |
May 9, 2013 |
August 9, 2016 |
|
- Sahlgrenska University Hospital
Gothenburg, Sweden
|
|
| 59 |
NCT03178487 |
Active, not recruiting |
A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis ( SELECT Axis 1 ) |
- Ankylosing Spondylitis (AS)
|
- Drug: Upadacitinib
- Drug: Upadacitinib Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Proportion of participants with Assessment of SpondyloArthritis international Society (ASAS) 40 response
- Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
- Proportion of participants with ASAS partial remission (PR)
- (and 10 more...)
|
187 |
All |
18 Years and older (Adult, Older Adult) |
NCT03178487 |
M16-098
2017-000431-14 |
SELECT Axis 1 |
October 24, 2017 |
November 11, 2020 |
November 11, 2020 |
June 7, 2017 |
November 8, 2018 |
|
- AZ Arthritis and Rheum Researc /ID# 165705
Phoenix, Arizona, United States - Arizona Arthritis & Rheumatolo /ID# 164446
Phoenix, Arizona, United States - David S. Hallegua MD /ID# 165090
Beverly Hills, California, United States - (and 99 more...)
|
|
| 60 |
NCT03667625 |
Completed |
Stretching in Water and on Land for Patients With Ankylosing Spondylitis |
|
- Other: Multidimensional Mobility Exercises
- Other: Control group
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Vital capacity
- Change in respiratory muscle strength
- Change in FVC
- (and 9 more...)
|
57 |
All |
18 Years to 50 Years (Adult) |
NCT03667625 |
DorkuzEU |
|
February 2016 |
July 2016 |
September 6, 2016 |
September 12, 2018 |
September 12, 2018 |
|
- Dokuz Eylul University School of Physical Therapy and Rehabilitation
Izmir, Turkey
|
|
| 61 |
NCT03761212 |
Recruiting |
Function, Locomotion, Measurement and Inflammation |
|
|
Observational
|
|
- University Hospital, Grenoble
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Gait speed
- Stride time
- Stride length
- (and 13 more...)
|
60 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03761212 |
38RC17.158. |
FoLoMI |
August 13, 2018 |
December 1, 2021 |
December 1, 2021 |
December 3, 2018 |
December 3, 2018 |
|
- CHU Grenoble Alpes - hôpital sud
Échirolles, France
|
|
| 62 |
NCT01358175 |
Completed
Has Results |
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis |
|
- Drug: Secukinumab (75 mg)
- Drug: Secukinumab (150 mg)
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response
- Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response
- Change From Baseline in Serum hsCRP
- (and 5 more...)
|
371 |
All |
18 Years and older (Adult, Older Adult) |
NCT01358175 |
CAIN457F2305
2010-024529-18 |
MEASURE 1 |
October 2011 |
December 2014 |
December 2014 |
May 23, 2011 |
March 9, 2017 |
January 27, 2017 |
- Novartis Investigative Site
Boise, Idaho, United States - Novartis Investigative Site
Cedar Rapids, Iowa, United States - Novartis Investigative Site
Portland, Oregon, United States - (and 64 more...)
|
|
| 63 |
NCT02763046 |
Recruiting |
A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis |
|
- Biological: AIN457/Secukinumab
- Drug: AIN457/Secukinumab Placebo
|
Interventional
|
Phase 4 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Proportion of patients achieving an ASAS20 response
- Change from baseline in ASAS-NSAID score
- Change from baseline in the total BASDAI
- (and 5 more...)
|
204 |
All |
18 Years and older (Adult, Older Adult) |
NCT02763046 |
CAIN457FDE03
2015-004575-74 |
ASTRUM |
May 31, 2016 |
July 1, 2019 |
July 1, 2019 |
May 5, 2016 |
December 5, 2018 |
|
- Novartis Investigative Site
Bad Doberan, Germany - Novartis Investigative Site
Bayreuth, Germany - Novartis Investigative Site
Berlin, Germany - (and 42 more...)
|
|
| 64 |
NCT00858819 |
Completed |
Clinical Trial of Osteoporosis in Ankylosing Spondylitis |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Crossover
- Time Perspective: Cross-Sectional
|
- The prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.
- To investigate which method is the most reliable for measuring bone mineral density in ankylosing spondylitis
|
250 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00858819 |
VGFOUREG11961 |
|
March 2009 |
May 2012 |
December 2014 |
March 10, 2009 |
May 29, 2015 |
|
- Department of Rheumatology and Inflammation Research
Gothenburg, Sweden
|
|
| 65 |
NCT02697968 |
Recruiting |
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis |
|
- Device: Electroacupuncture
|
Interventional
|
Not Applicable |
- The University of Hong Kong
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Pain Severity Numerical Rating Scale (NRS)
- Types and dosage of drug(s) intake
- Bath Ankylosing Spondylitis Functional Index (BASFI)
- (and 8 more...)
|
20 |
All |
Child, Adult, Older Adult |
NCT02697968 |
UW 15-458 |
|
March 2016 |
October 2017 |
June 2018 |
March 3, 2016 |
May 4, 2017 |
|
- The University of Hong Kong
Hong Kong, Hong Kong
|
|
| 66 |
NCT02809300 |
Unknown † |
Ankylosing Spondylitis and Antiphospholipid Antibodies |
- Ankylosing Spondylarthritis
|
- Biological: blood collection
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- presence or absence of APLA
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT02809300 |
PA15075 |
ASAA |
November 2015 |
March 2017 |
|
June 22, 2016 |
June 23, 2016 |
|
- Chu Reims
France, Reims, France
|
|
| 67 |
NCT00458185 |
Completed |
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis |
|
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.
- Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.
|
40 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00458185 |
0881A-101871 |
|
August 2006 |
|
April 2007 |
April 9, 2007 |
March 13, 2008 |
|
|
|
| 68 |
NCT02638896 |
Unknown † |
Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis |
|
- Drug: etanercept (Half-Dose)
- Drug: etanercept (Full-Dose)
- Drug: Sulfasalazine
- Drug: Celecoxib
|
Interventional
|
Phase 4 |
- Zhixiang Huang
- Health and Family Planning Commission of Guangdong
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in ASDAS from baseline to week48.
- Change in ESR from baseline to week48.
- Change in CRP from baseline to week48.
- (and 4 more...)
|
100 |
All |
18 Years to 45 Years (Adult) |
NCT02638896 |
2015117183344589 |
|
January 2016 |
February 2017 |
April 2017 |
December 23, 2015 |
December 28, 2015 |
|
|
|
| 69 |
NCT00444340 |
Completed |
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis |
|
- Drug: Enbrel (Etanercept)
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
- To assess the long-term clinical efficacy of etanercept in these study subjects.
|
70 |
All |
18 Years and older (Adult, Older Adult) |
NCT00444340 |
0881A3-101615 |
|
April 2004 |
|
July 2007 |
March 7, 2007 |
December 7, 2007 |
|
|
|
| 70 |
NCT01790022 |
Unknown † |
Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL) |
|
|
Interventional
|
Phase 2 |
- Saratov State Medical University
- Charite University, Berlin, Germany
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Assessment of Spondyloarthritis International Society 40 (ASAS40) response
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT01790022 |
METALL 2012 |
METALL |
July 2012 |
March 2013 |
|
February 12, 2013 |
February 12, 2013 |
|
- Department of Rheumatology, Saratov Region Hospital
Saratov, Russian Federation
|
|
| 71 |
NCT01109940 |
Completed |
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity)
- Immunogenicity of AIN457
- Total IL-17 concentration in blood at steady-state
- Pharmacokinetics of AIN457 at steady state
|
39 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01109940 |
CAIN457A2209E1
2009-011591-30 |
|
April 2010 |
December 2012 |
December 2012 |
April 23, 2010 |
November 16, 2016 |
|
- Novartis Investigative Site
Paradise Valley, Arizona, United States - Novartis Investigative Site
Springfield, Illinois, United States - Novartis Investigative Site
Springfield, Illinois, United States - (and 12 more...)
|
|
| 72 |
NCT00085644 |
Completed
Has Results |
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis |
|
- Biological: adalimumab (D2E7)
- Biological: placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).
- Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score
- Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure
- (and 34 more...)
|
315 |
All |
18 Years and older (Adult, Older Adult) |
NCT00085644 |
M03-607 |
ATLAS |
January 2004 |
December 2004 |
July 2009 |
June 16, 2004 |
April 21, 2011 |
March 11, 2010 |
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- San Francisco, California, United States
- (and 19 more...)
|
|
| 73 |
NCT02988674 |
Active, not recruiting |
A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation |
- Spondylarthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis (AS)
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of participants on adalimumab therapy
- Number of participants on adalimumab therapy
- Assessing medication persistence
- (and 3 more...)
|
139 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT02988674 |
P15-672 |
Adherence |
December 22, 2016 |
November 30, 2019 |
November 30, 2019 |
December 9, 2016 |
October 3, 2018 |
|
- Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
Kemerovo, Kemerovskaya Oblast, Russian Federation - Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379
Moscow, Moskva, Russian Federation - Ivanovo Regional Clinical Hosp /ID# 167028
Ivanovo, Russian Federation - (and 11 more...)
|
|
| 74 |
NCT00418548 |
Completed |
Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis |
|
|
Interventional
|
Phase 3 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.
|
350 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00418548 |
0881A3-314 |
|
June 2004 |
|
February 2005 |
January 5, 2007 |
January 5, 2007 |
|
|
|
| 75 |
NCT03211559 |
Completed |
Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis |
- Exercise
- Ankylosing Spondylitis
|
|
Interventional
|
Not Applicable |
- Eastern Mediterranean University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Aerobic capacity will be detected with submaximal exercise testing (modified Bruce protocol).
- Lateral spinal flexion distance was measured
- Lumbal flexion distance was measured
- (and 20 more...)
|
36 |
All |
20 Years to 70 Years (Adult, Older Adult) |
NCT03211559 |
GO 16/147 |
|
October 2015 |
April 2016 |
December 2016 |
July 7, 2017 |
July 11, 2017 |
|
- Eastern Mediterranen University
Famagusta, Cyprus
|
|
| 76 |
NCT01417455 |
Completed
Has Results |
Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis |
- Rheumatoid Arthritis
- Bone Resorption
- Ankylosing Spondylitis
|
|
Observational
|
|
- Instituto de Medicina Molecular João Lobo Antunes
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Time Perspective: Prospective
|
- Osteoclast Differentiation Ex-vivo
- Osteoclast Activity Ex-vivo
|
101 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01417455 |
BCRAAS |
|
January 2012 |
January 2015 |
May 2015 |
August 16, 2011 |
March 21, 2016 |
March 21, 2016 |
- Instituto de Medicina Molecular
Lisbon, Portugal
|
|
| 77 |
NCT02896127 |
Active, not recruiting |
Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis |
- Ankylosing Spondyloarthritis
|
- Drug: Secukinumab
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The proportion of participants who achieve an ASAS 20 response (Assessment of SpondyloArthritis International Society criteria)
- The proportion of participants who achieve an ASAS 40 reponse
- Change in hsCRP over time
- (and 5 more...)
|
459 |
All |
18 Years and older (Adult, Older Adult) |
NCT02896127 |
CAIN457F2308 |
|
October 18, 2016 |
May 14, 2018 |
March 21, 2019 |
September 12, 2016 |
January 11, 2019 |
|
- Novartis Investigative Site
Hefei, Anhui, China - Novartis Investigative Site
Hefei, Anhui, China - Novartis Investigative Site
Beijing, Beijing, China - (and 41 more...)
|
|
| 78 |
NCT00207701 |
Completed |
A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis. |
|
|
Interventional
|
Phase 3 |
- Centocor, Inc.
- Centocor BV
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
- The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24
|
279 |
All |
18 Years and older (Adult, Older Adult) |
NCT00207701 |
CR004792 |
|
September 2002 |
|
February 2005 |
September 21, 2005 |
May 17, 2011 |
|
|
|
| 79 |
NCT00421915 |
Completed |
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis |
|
- Drug: Enbrel (etanercept)
|
Interventional
|
Phase 3 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
- percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
- To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
- compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
|
84 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00421915 |
0881A3-311 |
|
March 2002 |
|
August 2002 |
January 15, 2007 |
January 15, 2007 |
|
|
|
| 80 |
NCT00558506 |
Unknown † |
Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2 |
- Charite University, Berlin, Germany
- Bristol-Myers Squibb
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ASAS40 response rate in TNF-blocker naïve and in TNF-blocker failure patients
- Safety Evaluations: Adverse events, vital signs, physical examination results, and clinical laboratory values
- ASAS20 response
- (and 13 more...)
|
30 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00558506 |
ABATACEPT-AS-01 |
Aba-AS-01 |
January 2008 |
October 2009 |
December 2009 |
November 15, 2007 |
February 26, 2008 |
|
- Charité University Medicine Berlin, Campus Benjamin-Franklin
Berlin, Germany - Rheumazentrum Ruhrgebiet
Herne, Germany
|
|
| 81 |
NCT01163916 |
Completed
Has Results |
Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care |
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
|
|
Observational
|
|
- Abbott
- Scientific Research Institute of Rheumatology, Moscow
- Almedis
|
Industry / Other |
- Time Perspective: Prospective
|
- Characteristics of Patients Prescribed Adalimumab: Education Level
- Characteristics of Patients Prescribed Adalimumab: Occupation
- Characteristics of Patients Prescribed Adalimumab: Residence Status
- (and 7 more...)
|
252 |
All |
18 Years and older (Adult, Older Adult) |
NCT01163916 |
P10-272 |
|
January 2008 |
November 2011 |
November 2011 |
July 16, 2010 |
December 7, 2012 |
December 5, 2012 |
- Site Ref # / Investigator 50728
Belgorod, Russian Federation - Site Ref # / Investigator 50737
Chelyabinsk, Russian Federation - Site Reference ID/Investigator# 6002
Ekaterinburg, Russian Federation - (and 40 more...)
|
|
| 82 |
NCT01586650 |
Completed |
Effects of Aerobic Training in Patients With Ankylosing Spondylitis |
|
- Other: aerobic training
- Other: Stretching exercises
|
Interventional
|
Phase 3 |
- Federal University of São Paulo
- Fundação de Amparo à Pesquisa do Estado de São Paulo
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in BASFI
- Change in BASDAI
- Change in BASMI
- (and 5 more...)
|
70 |
All |
18 Years to 60 Years (Adult) |
NCT01586650 |
1325/08 |
|
July 2011 |
November 2012 |
February 2013 |
April 27, 2012 |
February 15, 2017 |
|
- Universidade Federal de Sao Paulo
Sao Paulo, Brazil
|
|
| 83 |
NCT00237419 |
Unknown † |
Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis |
|
|
Interventional
|
Not Applicable |
- Rheumazentrum Ruhrgebiet
- Centocor BV
- Trial Coordination Center, 9713 GZ Groningen
- PPD
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Degree of structural damage (radiographic progression)after 4 and 6 years of infliximab therapy (2 years of ASSERT trial plus 2 years of EASIC trial)
- Proportion of patients which have received anti-TNF-alpha therapy as standard care after the end of ASSERT
- Description of the various treatment regimens after the end of ASSERT of the participating AS patients in various countries
- (and 5 more...)
|
149 |
All |
18 Years and older (Adult, Older Adult) |
NCT00237419 |
EASIC 30505 |
|
December 2005 |
November 2010 |
April 2011 |
October 12, 2005 |
June 3, 2008 |
|
- Erasme University Hospital
Brussels, Belgium - Limburg University Centre
Diepenbeek, Belgium - Universitair Ziekenhuis, Afdeling Rheumatologie
Gent, Belgium - (and 12 more...)
|
|
| 84 |
NCT02359903 |
Completed
Has Results |
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis |
|
- Drug: Infliximab (BCD-055)
- Drug: Infliximab (Remicade)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
- Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
- Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade
- (and 18 more...)
|
90 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02359903 |
BCD-055-1/ASART-1 |
|
February 2015 |
November 2015 |
November 2015 |
February 10, 2015 |
June 8, 2016 |
June 8, 2016 |
- Vitebsk Regional Clinical Hospital
Vitebsk, Belarus - Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russian Federation - Research Institute of Rheumotology
Moscow, Russian Federation - (and 3 more...)
|
|
| 85 |
NCT00432653 |
Unknown † |
Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis |
|
|
Interventional
|
Phase 2
Phase 3 |
- Charite University, Berlin, Germany
- Hoffmann-La Roche
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation in week 24 and until study end: ASAS 20 in AS patients naïve to TNFalpha inhibitors as well as in AS patients with previous therapy with TNFalpha inhibitors.
- Safety Evaluations (Adverse events, vital signs, physical examination results, and clinical laboratory values until week 48)
- Efficacy Evaluations:
- (and 18 more...)
|
20 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00432653 |
Ritux-AS-01 |
|
March 2007 |
|
November 2009 |
February 8, 2007 |
February 8, 2007 |
|
- Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology
Berlin, Germany - Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus
Herne, Germany
|
|
| 86 |
NCT00265083 |
Completed
Has Results |
A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis |
|
- Biological: golimumab
- Biological: Golimumab (CNTO 148); placebo
|
Interventional
|
Phase 3 |
- Centocor, Inc.
- Schering-Plough
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assessment in Ankylosing Spondylitis 20 Responders at Week 14
- Assessment in Ankylosing Spondylitis 20 Responders at Week 24
- Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14
- Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14
|
356 |
All |
18 Years and older (Adult, Older Adult) |
NCT00265083 |
CR006337
C0524T09 |
|
December 2005 |
March 2007 |
January 2012 |
December 14, 2005 |
July 19, 2013 |
July 13, 2009 |
- Paradise Valley, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- (and 36 more...)
|
|
| 87 |
NCT00762463 |
Completed
Has Results |
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis |
|
- Drug: Celecoxib
- Drug: Diclofenac SR
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
- Participant's Assessment of Global Pain Intensity at Baseline
- Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4
- (and 23 more...)
|
240 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00762463 |
A3191348 |
|
July 2009 |
June 2010 |
August 2010 |
September 30, 2008 |
August 23, 2011 |
August 23, 2011 |
- Pfizer Investigational Site
Guangzhou, Guangdong, China - Pfizer Investigational Site
Xi'an, Shanxi, China - Pfizer Investigational Site
Chengdu, Sichuan, China - (and 2 more...)
|
|
| 88 |
NCT00410046 |
Completed
Has Results |
Extension Study Evaluating Etanercept in Ankylosing Spondylitis |
|
- Drug: Enbrel (etanercept)
|
Interventional
|
Phase 4 |
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients Using Healthcare Resources in the 48 Weeks Before and During Treatment
- Number of Patients Taking Sick Leave in the 48 Weeks Before and During Treatment
- Number of Patients Utilizing Healthcare Resources During 48 Weeks of Treatment
- (and 11 more...)
|
84 |
All |
18 Years and older (Adult, Older Adult) |
NCT00410046 |
0881A3-405 |
|
December 2006 |
October 2008 |
October 2008 |
December 12, 2006 |
May 11, 2012 |
May 11, 2012 |
- Fredriksberg, Denmark
- Odense, Denmark
- Svendborg, Denmark
- (and 13 more...)
|
|
| 89 |
NCT03636984 |
Not yet recruiting |
Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World |
- Rheumatoid Arthritis
- Ankylosing Spondylitis
|
- Drug: recombinant TNF-α receptor: IgG Fc fusion protein
|
Observational
|
|
- Zhejiang Hisun Pharmaceutical Co. Ltd.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percent of participants achieving clinical remission defined as a DAS28 ≥1.2
- Percent of participants achieving bath ankylosing spondylitis disease activity index (BASDAI) 50 response.
- Change From baseline in the modified total Sharp score to week 48
|
1000 |
All |
18 Years and older (Adult, Older Adult) |
NCT03636984 |
Bioinno-ABN-2018001 |
|
August 24, 2018 |
July 24, 2020 |
December 24, 2020 |
August 17, 2018 |
August 17, 2018 |
|
|
|
| 90 |
NCT02685904 |
Recruiting |
A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis |
|
- Biological: ENIA11
- Biological: Placebo
|
Interventional
|
Phase 3 |
- Mycenax Biotech Inc.
- TSH Biopharm Corporation Limited
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- ASAS 20 responder at Week 12
|
90 |
All |
20 Years and older (Adult, Older Adult) |
NCT02685904 |
TSHEN1502 |
|
September 2016 |
December 2018 |
December 2018 |
February 19, 2016 |
April 17, 2018 |
|
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan - Chung Shan Medical University Hospital
Taichung, Taiwan - Far Eastern Memorial Hospital
Taipei, Taiwan - (and 3 more...)
|
|
| 91 |
NCT01361542 |
Completed |
Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population |
|
- Drug: anti TNF alpha agent
- Drug: Anti TNF alpha therapy
|
Interventional
|
Not Applicable |
- All India Institute of Medical Sciences, New Delhi
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Increase in bone mineral density and decrease in disease activity
- Observation of adverse effects of Anti TNF therapy
|
24 |
All |
18 Years to 55 Years (Adult) |
NCT01361542 |
SKS/ASTNF/TB/2011 |
|
February 2011 |
December 2011 |
January 2012 |
May 27, 2011 |
January 26, 2012 |
|
- All India Institute of Medical Sciences
New Delhi, Delhi, India
|
|
| 92 |
NCT01209702 |
Terminated
Has Results |
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs |
|
- Biological: tocilizumab
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12
- Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12
- Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24
- (and 18 more...)
|
306 |
All |
18 Years and older (Adult, Older Adult) |
NCT01209702 |
NA22823
2009-017443-34 |
|
September 2010 |
May 2011 |
December 2011 |
September 27, 2010 |
February 11, 2013 |
February 11, 2013 |
- Huntington Beach, California, United States
- Aventura, Florida, United States
- Orlando, Florida, United States
- (and 136 more...)
|
|
| 93 |
NCT00544557 |
Completed
Has Results |
Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of Participants Achieving Partial Remission at Week 26
- Percentage of Participants Achieving Partial Remission at Week 52
- Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
- (and 25 more...)
|
1715 |
All |
18 Years and older (Adult, Older Adult) |
NCT00544557 |
0881X1-4463
B1801087 |
|
October 2007 |
May 2014 |
May 2014 |
October 16, 2007 |
May 12, 2015 |
May 12, 2015 |
- Klinikum Benjamin Franklin
Berlin, Germany
|
|
| 94 |
NCT01188655 |
Completed
Has Results |
Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis |
|
|
Observational
|
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Percentage of Participants Achieving BASDAI 40 Response at Week 24
- Change From Baseline in BASDAI at Week 12 and 24
- Change From Baseline in the BASFI at Weeks 12 and 24
- (and 9 more...)
|
89 |
All |
18 Years and older (Adult, Older Adult) |
NCT01188655 |
0881X1-4456
B1801095 |
|
May 2008 |
March 2010 |
March 2010 |
August 25, 2010 |
September 12, 2011 |
April 26, 2011 |
|
|
| 95 |
NCT00439283 |
Completed |
Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis |
|
- Drug: infliximab
- Drug: methotrexate
|
Interventional
|
Phase 3 |
- Association de Recherche Clinique en Rhumatologie
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
- Achievement of the ASAS50 and ASAS70.
- The proportion of patients who experienced a partial remission, according to ASAS definition.
- (and 12 more...)
|
240 |
All |
18 Years and older (Adult, Older Adult) |
NCT00439283 |
A R C R 2003 - 01 / PO 3353 |
|
April 2003 |
|
December 2004 |
February 23, 2007 |
February 27, 2007 |
|
- CHU Amiens
Amiens, France - CHU Hôpital Minjoz
Besançon, France - Hôpital Avicenne
Bobigny, France - (and 28 more...)
|
|
| 96 |
NCT02489760 |
Unknown † |
Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study |
|
- Biological: Adalimumab
- Biological: Etanercept
|
Interventional
|
Phase 4 |
- Chung Shan Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bath AS disease activity index (BASDAI)
|
30 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02489760 |
CS08019 |
|
July 2008 |
December 2015 |
October 2016 |
July 3, 2015 |
January 20, 2016 |
|
- Chung Shan Medical University Hospital
Taichung, Taiwan
|
|
| 97 |
NCT02469753 |
Recruiting |
Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes |
|
- Drug: NSAIDs
- Drug: anti-TNF
|
Interventional
|
Phase 3 |
- University Hospital, Bordeaux
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients who show a significant radiographic progression between the two randomised groups of patients
- Radiologic evolution between-group comparison
|
225 |
All |
18 Years and older (Adult, Older Adult) |
NCT02469753 |
CHUBX2014/36 |
STOP |
October 23, 2015 |
June 2022 |
June 2022 |
June 11, 2015 |
December 14, 2018 |
|
- Service de rhumatologie - CHU d'Amiens
Amiens, France - Service de rhumatologie - CHU de Besançon
Besancon, France - Service de Rhumatologie - CHU de Bordeaux
Bordeaux, France - (and 19 more...)
|
|
| 98 |
NCT00244166 |
Unknown † |
Prednisolone in Active Ankylosing Spondylitis (AS) |
|
|
Interventional
|
Phase 2
Phase 3 |
- Charite University, Berlin, Germany
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- 50% improvement of BASDAI after 14 days of treatment
- Improvement of pain on a VAS 0 - 10
- Decrease of CRP/ BSG
- (and 4 more...)
|
75 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00244166 |
P-01 |
|
May 2002 |
|
August 2008 |
October 26, 2005 |
September 11, 2006 |
|
- Charité Campus Benjamin-Franklin Rheumatolgy
Berlin, Germany - Immanuel Hospital Rheumatology
Berlin, Germany - Rheumazentrum Ruhrgebiet
Herne, Germany
|
|
| 99 |
NCT01934933 |
Completed |
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis |
|
- Drug: celebrex
- Drug: Enbrel
- Drug: Enbrel plus Celebrex
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the SPARCC score of spine and SI joint
- ASAS20 response rate
- ASAS40 response rate
- (and 4 more...)
|
150 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01934933 |
[2013]2-93 |
|
September 24, 2014 |
September 23, 2015 |
January 30, 2017 |
September 4, 2013 |
June 18, 2018 |
|
- Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
|
|
| 100 |
NCT00195416 |
Completed |
Study Investigating Enbrel Treatment for Ankylosing Spondylitis |
|
|
Observational
|
|
- Wyeth is now a wholly owned subsidiary of Pfizer
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
526 |
All |
18 Years and older (Adult, Older Adult) |
NCT00195416 |
0881A-102018 |
|
June 2005 |
August 2008 |
August 2008 |
September 19, 2005 |
September 16, 2009 |
|
- Gyunggi-do, Korea, Republic of
- Seoul, Korea, Republic of
- Seoul, Korea, Republic of
|
|
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