horizon scanning spondyloarthropathies first annual update ... · spondylarthropathies,...
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Written by Nadia Corp for: © Arthritis Research UK 2012
HORIZON SCANNING: SPONDYLOARTHROPATHIES
FIRST ANNUAL UPDATE: FEBRUARY 2012 The object of these Horizon Scanning reports is to highlight recently completed and ongoing clinical trials, research recommendations and new and emerging health technologies. This follow up report includes trials registered since February 2011 (with completion dates after January 2009). Following the initial horizon scan in February 2011, it was decided that diseases associated with spondyloarthropathies, namely psoriasis, ulcerative colitis and Crohn’s disease, would be included in biennial, rather than annual, updates: thus, will be included in the 2013 update. Details of all material included in this report are shown in the appendix: with the exception of drug trials, which are ordered according to drug name, studies in the remaining categories are ordered in reverse chronological order. Further details of each study can be obtained via the links given to the relevant webpage.
CONTENTS SEARCH METHODOLOGY 2
RESULTS 3
ABBREVIATIONS 3
APPENDIX: CLINICAL TRAILS 4
A1: Ankylosing spondylitis ………………….………………………………………………. 4
Behavioural, education & exercise including physiotherapy 4
Device 5
Drugs including biologics 6
Procedures 8
Other including CAM therapies 9
Miscellaneous observational studies 9
A2: Psoriatic arthritis ……………………………………………………………………………….. 12
Behavioural, education & exercise including physiotherapy 12
Drugs including biologics 12
Miscellaneous observational studies 15
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A3: Reactive arthritis ……………………………………………………………………………….. 16
A4: Other spondyloarthropathies ………………………………………………………….. 16
Drugs including biologics 16
Miscellaneous observational studies 17
SEARCH METHODOLOGY Clinical Trials Databases Searched
Australian New Zealand Clinical Trials Registry (ANZCTR)
ClinicalTrials.gov, US
German Clinical Trials Register (DRKS)
ISRCTN Register, UK
University Hospital Medical Information Network (UMIN), Japan
Japan Medical Association Center for Clinical Trials Register (JMA-CTR)
Japan Pharmaceutical Information Center Clinical Trials Register (JAPIC)
MRC Clinical Trials Unit, UK
The Netherlands National Trial Register (NTR)
UKCRN Portfolio Database, UK
EU Clinical Trials Registry
World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), to
include trials from the following registers:
o Chinese Clinical Trial Register (ChiCTR) o Clinical Research Information Service (CRiS), Republic of Korea o Clinical Trials Registry - India (CTRI) o Cuban Public Registry of Clinical Trials (RPCEC) o Iranian Registry of Clinical Trials (IRCT) o Pan African Clinical Trial Registry (PACTR) o Sri Lanka Clinical Trials Registry (SLCTR)
Keywords searched Ankylosing spondylitis, spondyloarthropathy, spondyloarthropathies, spondylarthropathy, spondylarthropathies, spondyloarthritis, spondyloarthritis, spondarthritis, psoriatic arthritis, reactive arthritis, Reiter’s arthritis. Keywords and phrases were used separately or in combination; truncation was used where possible/applicable. Date limits Clinical trials: added to databases since February 2011 and completed since January 2009.
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RESULTS
Between February 2011 and February 2012, 69 completed or ongoing clinical trails were identified relating to spondyloarthropathies: these are tabulated in the appendix divided into the following pathologies:
A1: Ankylosing spondylitis including axial spondylitis (n = 36); A2: Psoriatic arthritis (n = 17); A3: Reactive arthritis (n = 0); A4: Other spondyloarthropathies (n = 16);
For clarity each section is subdivided according to type of intervention: Behavioural, education & exercise including physiotherapy; Device; Dietary supplements; Drugs including biologics; Procedures; Others including CAM therapies and Miscellaneous observational studies. Sub-categories, with the exception of drugs including biologics sub-category which is ordered according to drug name/identifier, are ordered in reverse chronological order. Unless otherwise stated in the table trials involve participants of both genders. Each clinical trial has a weblink which can be followed for further details of the study.
ABBREVIATIONS
Adt Adult (18-65 years) CAM Complementary and Alternative Medicine Child Child (<18 years) Comp Completed CT ID Clinical Trials Identifier DMARD Disease-Modifying Antirheumatic Drugs Grp Group Invite Invite only JIA Juvenile idiopathic arthritis n Enrollement N/K Not known NR NR NSAID Non-steroidal anti-inflammatory drug OA Osteoarthritis RA Rheumatoid arthritis Rec Rec Recruit Recruitment Sen Senior (>65 years) SLE Systemic Lupus Erythematosus Term Terminated
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CLINICAL TRIALS Clinical trials identity number (CT ID): Prefix of ACTRN denotes Australian New Zealand Clinical Trials Registry; ChiCTR - Chinese Clinical Trial Register; CTRI - Clinical Trials Registry, India; DRK – German clinical Trials Register; EudraCT – EU Clinical Trials Register [including countries involved : AT - Austria; BG - Belgium; CZ
- Czech Republic; DE - Germany; EE - Estonia; EI – Republic of Ireland; ES - Spain; FI - Finland; FR – France; GB - Great Britain; GR - Greece; HU - Hungary; IS – Iceland; LT –
Lithuania; NL - The Netherlands]; NCT - National Clinical Trials Identifier; IRCT - Iranian Registry of Clinical Trials; ISRCTN - International Standard Randomized Controlled Trial Number; JapicCTI - Japan Pharmaceutical Information Center Clinical Trials; JMA - Japan Medical Association Center for Clinical Trials Register; KCT - Clinical Research Information Service (CRiS), Republic of Korea; NTR – Nederland Trial Register; PACTR - Pan African Clinical Trial Registry; RPCEC - Cuban Public Registry of Clinical Trials; SLCTR - Sri Lanka Clinical Trials Registry; UKCRN – UK Clinical Research Network; UMIN – University Hospital Medical Information Network. Note: Where no end date was given the following were used: completion date for primary outcome measure – italics; last update – preceeded with a ?; start date + final timepoint of outcomes – preceeded with a >.
A1: ANKYLOSING SPONDYLITIS including axial spondylitis
Title Phases: study design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy
Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis RCT (no intervention), efficacy study NCT01351311
Exercise; no intervention
Ankylosing Spondylitis
Rec 54 Adult May-11 Dec-12 Federal University of São Paulo; Fundação de Amparo à Pesquisa do Estado de São Paulo
http://ClinicalTrials.gov/show/NCT01351311
Web-based Support to Manage Arthritis Pain Phase II: RCT (active), efficacy study NCT01463189
painACTION: Arthritis; Treatment as usual
Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Other Arthritic Conditions (e.g., Psoriatic Arthritis)
Rec 228 Adt Sen
Sep-11 Sep-12 Inflexxion, Inc. http://ClinicalTrials.gov/show/NCT01463189
5
Phone call follow-up after RheumAtologIcal rehabilitation Stays: Evaluation of effects RCT (active), efficacy study ISRCTN91433175
PRAISE rehabilitation programme; treatment as usual
Inflammatory rheumatic diagnoses including RA, psoriatric arthritis, ankylosing spondylitis, SLE, JIA or generalised OA of hip or knee
Active 312 Adt Sen
Aug-11 Jun-12 Diakonhjemmet Hospital (Norway)
http://www.controlled-trials.com/ISRCTN91433175
Effect of Exercise on Disease Activity and Cardiovascular Risk Factors in Patients With Ankylosing Spondylitis RCT (no intervention), efficacy study NCT01436942
Exercise; no intervention
Ankylosing Spondylitis
Rec 40 Adt Sen
Sep-11 May-12 Diakonhjemmet Hospital; University of Oslo
http://ClinicalTrials.gov/show/NCT01436942
Device
Effects of Incentive spirometer on pulmonary functions in the patients with ankylosing spondylitis RCT (active), efficacy study KCT0000051
Incentive spirometer + Conventional treatment; Conventional treatment only
Ankylosing spondylitis
Rec 46 Child Adt Sen
Nov-10 Nov-11 Asan Medical Center
http://cris.cdc.go.kr/cris/en/search/search_result_st01.jsp?seq=1649
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem Phase IV: RCT (active), safety/efficacy study NCT01422564
Metal on Metal Hip System; Highly Cross Linked Polyethylene cup System
Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Congenital Dysplasia of the Hip; Ankylosing Spondylitis; Post-traumatic; Arthrosis; Injury of Hip and Thigh
Term 41 Adt Sen
Jan-07 Dec-10 Capital District Health Authority, Canada; University Health Network, Toronto
http://ClinicalTrials.gov/show/NCT01422564
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Drugs including biologics
Effect Of Anti TNF Alpha Therapy And Their Adverse Effects In Ankylosing Spondylitis In A North Indian Population Single group assignment, safety/efficacy study NCT01361542
Anti TNF alpha agent
Ankylosing Spondylitis
Comp 24 Adt Feb-11 Jan-12 All India Institute of Medical Sciences, New Delhi
http://ClinicalTrials.gov/show/NCT01361542
A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department Phase IV: Prospective, case control study NCT01411215
Enbrel Rheumatoid Arthritis; Ankylosing Spondylitis
Rec 600 Adt Sen
Jan-11 Nov-13 Pfizer http://ClinicalTrials.gov/show/NCT01411215
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel. Phase IV: Prospective cohort study NCT01421303
Enbrel Ankylosing Spondylitis
Rec 120 Adt Sen
Nov-09 Nov-13 Pfizer http://ClinicalTrials.gov/show/NCT01421303
Low dose etanercept for the treatment of patients with ankylosing spondylitis RCT (active), efficacy study ISRCTN45278838
Etanercept Ankylosing Spondylitis
Active 50 Adt Sen
Oct-10 Apr-12 Norfolk and Norwich University Hospital NHS Foundation Trust (UK)
http://www.controlled-trials.com/ISRCTN45278838
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis Phase IV: RCT (placebo), efficacy study NCT01298531
Etanercept; placebo
Axial Spondyloarthritis
Rec 80 Adt Sen
Mar-11 Mar-12 Pfizer http://ClinicalTrials.gov/show/NCT01298531
Effects 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 RCT (placebo), safety/efficacy study EudraCT 2007-003096-39 [IT]
Etanercept; Placebo
Ankylosing spondylitis
Active 84 Adt Sen
Jul-09 N/K Wyeth Lederle https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003096-39/IT
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Safety of Etoricoxib (Mk-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082) Retrospective cohort study NCT01327638
Etoricoxib; Other COX-2 inhibitor; nsNSAIDs
Spondylarthropathies; Spondylitis, Ankylosing
Active, NR
16671
Child Adt Sen
Feb-11 Jun-14 Merck; Lund University
http://ClinicalTrials.gov/show/NCT01327638
Febuxostat versus Allopurinol Streamlined Trial (FAST) RCT (active), efficacy study ISRCTN72443728
Febuxostat; Allopurinol
Gout plus further cardiovascular risk including Inflammatory arthritis (e.g. RA, psoriatic arthritis, ankylosing spondylitis)
Active 5706 Adt Sen
Sep-11 Sep-16 University of Dundee (UK)
http://www.controlled-trials.com/ISRCTN72443728/
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642) Phase III: RCT (placebo), efficacy study NCT01453725
Golimumab; Placebo
Spondylitis, Ankylosing
Rec 200 Adult Jan-12 Mar-14 Schering-Plough; Johnson & Johnson
http://ClinicalTrials.gov/show/NCT01453725
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS) Phase I: RCT (active), safety/efficacy study NCT01420432
Human umbilical cord-derived MSCs; DMARDs
Ankylosing Spondylitis
Rec 10 Adult Jan-11 Dec-13 Shandong University
http://ClinicalTrials.gov/show/NCT01420432
Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy Phase IV: RCT (active), safety/efficacy study NCT01517620
Total Glucosides Paeony Capsules; NSAIDs
Ankylosing Spondylitis
Active, NR
30 ChildAdt
Nov-11 Nov-12 Sun Yat-sen University
http://ClinicalTrials.gov/show/NCT01517620
8
Efficacy at 16 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) Phase III: RCT (placebo), safety/efficacy study NCT01358175
Secukinumab (75 mg); Secukinumab (150 mg); Placebo
Ankylosing Spondylitis
Rec 348 Adt Sen
Jul-11 Jul-14 Novartis Pharmaceuticals
http://ClinicalTrials.gov/show/NCT01358175
A Study to Investigate the Use of Simponi® in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) Prospective cohort study NCT01313858
Simponi® Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing
Rec 1500 Adt Sen
Apr-10 Dec-14 Schering-Plough http://ClinicalTrials.gov/show/NCT01313858
Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide ChiCTR-TNRC-10000858
Thalidomide Ankylosing Spondylitis; Healthy
NR 27 Adt May-10 N/K Chinese PLA General Hospital (China)
http://apps.who.int/trialsearch/Trial.aspx?TrialID=ChiCTR-TNRC-10000858
Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis Phase II: Single group assignment, safety/efficacy study NCT01330901
Ustekinumab Ankylosing Spondylitis
Rec 20 Adt Sen
Oct-11 Dec-12 Charite University, Berlin, Germany
http://ClinicalTrials.gov/show/NCT01330901
Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis Phase II: Single group assignment, safety/efficacy study NCT01330901
Ustekinumab Ankylosing Spondylitis
Rec 20 Adt Sen
Oct-11 Dec-12 Charite University, Berlin, Germany
http://ClinicalTrials.gov/show/NCT01330901
Procedures
Clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis ChiCTR-TRC-11001417
Mecenchymal Stem Cells transplantation
Ankylosing spondylitis
N/K 160 Child Adt
Jun-11 M/K Sun Yat-sen University (China)
http://apps.who.int/trialsearch/Trial.aspx?TrialID=ChiCTR-TRC-11001417
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Other including CAM therapies
Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial RCT (placebo), efficacy study ChiCTR-TRC-10001193
Tripterygium wilfordii; Placebo
Ankylosing spondylitis
Active NR
88 Adt Jan-11 N/K Jiangsu Provincial Hospital of Traditional Chinese Medicine (China)
http://apps.who.int/trialsearch/Trial.aspx?TrialID=ChiCTR-TRC-10001193
Integrated Traditional Chinese and Western medicine for ankylosing spondylitis ChiCTR-TRC-10001274
Integrated TCM and Western medicine
Ankylosing spondylitis
Rec 480 Adt Apr-10 N/K Development and Reform Commission of Guangdong Province (China)
http://apps.who.int/trialsearch/Trial.aspx?TrialID=ChiCTR-TRC-10001274
Miscellaneous observational studies
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis Prospective cohort study NCT01387802
Ankylosing Spondylitis
Rec 1120 Adt Sen
Jul-11 Jul-15 Abbott; JSS Medical Research Inc.; CATO Research Canada
http://ClinicalTrials.gov/show/NCT01387802
Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis Prospective NCT01417455
Cytokine Environment; Kinetics of Bone Cells Differentiation and Activity in Untreated RA and AS Patients.
Not yet Rec
125 Adt Sen
Jan-12 Jan-15 Instituto de Medicina Molecular; Merck
http://ClinicalTrials.gov/show/NCT01417455
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation) Prospective cohort study NCT01329380
Ankylosing Spondylitis
Rec 100 Child Adt Sen
Nov-10 Dec-14 Abbott http://ClinicalTrials.gov/show/NCT01329380
10
Ankylosing Spondylitis and Spondyloarthritis Evaluation Tool Study Prospective NCT01302730
Ankylosing Spondylitis; Spondylarthritis
Not yet Rec
400 Adt Sen
Apr-11 Dec-14 Stanford University; University of California, San Francisco; Oregon Health and Science University; Cedars-Sinai Medical Center
http://ClinicalTrials.gov/show/NCT01302730
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis Prospective NCT01474876
Ankylosing Spondylitis; Psoriatic Arthritis
Rec 800 Adt Sen
Nov-11 Nov-13 Abbott http://ClinicalTrials.gov/show/NCT01474876
Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns Retrospective cohort study NCT01511926
Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis
Not yet Rec
2000 Adt Sen
Jan-12 Jun-13 AstraZeneca http://ClinicalTrials.gov/show/NCT01511926
The prevalence of inflammatory back pain and SpondyloArthropathies in a primary care population in Norfolk Cross-sectional cohort study ISRCTN76873217
Ankylosing spondylitis; Axial spondylo-arthropathy
Ongoing 1000 Adt Sen
Sep-11 Jul-12 University of East Anglia (UK)
http://www.controlled-trials.com/ISRCTN76873217/
The CORRONA Data Collection Program Prospective cohort study NCT01402661
Rheumatoid Arthritis; Psoriatic Arthritis; Other Rheumatic Conditions
Invite 33312
Adt Sen
Feb-02 Aug-11 The Consortium of Rheumatology Researchers of North America, Inc.; University of Massachusetts, Worcester; University of Alabama at Birmingham; Brigham and Women's Hospital
http://ClinicalTrials.gov/show/NCT01402661
11
Respiratory muscle function in patient with ankylosing spondylitis Diagnostic study DRKS00003528
Ankylosing spondylitis; Healthy individuals
Active 70 Adt Sen
Jan-12 N/K Universtitätsklinikum Freiburg (Germany)
https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00003528
Natural History and Development of Spondyloarthritis Prospective NCT01422694
Arthritis; Spondylitis, Ankylosing
Rec 200 Child Adt Sen
Aug-11 Jul-11 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
http://ClinicalTrials.gov/show/NCT01422694
Research of genetic gene and immune state in Ankylosing Spondylitis ChiCTR-OCC-11001565
Ankylosing spondylitis
Rec 1000 Adt Jun-09 N/K Xijing Hospital (Japan)
http://apps.who.int/trialsearch/Trial.aspx?TrialID=ChiCTR-OCC-11001565
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A2: PSORIATIC ARTHRITIS
Title Phases: study design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy
Web-based Support to Manage Arthritis Pain Phase II: RCT (no intervention), efficacy study NCT01463189
painACTION: Arthritis
Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Other Arthritic Conditions (e.g., Psoriatic Arthritis)
Rec 228 Adt Sen
Sep-11 Sep-12 Inflexxion, Inc. http://ClinicalTrials.gov/show/NCT01463189
Phone call follow-up after RheumAtologIcal rehabilitation Stays: Evaluation of effects RCT (active), efficacy study ISRCTN91433175
PRAISE rehabilitation programme; treatment as usual
Inflammatory rheumatic diagnoses including RA, psoriatric arthritis, ankylosing spondylitis, SLE, JIA or generalised OA of hip or knee
Active 312 Adt Sen
Aug-11 Jun-12 Diakonhjemmet Hospital (Norway)
http://www.controlled-trials.com/ISRCTN91433175
Drugs including biologics
Abatacept in Psoriasis and Psoriatic Arthritis: a single centre, placebo-controlled, crossover study in 20 patients. RCT (placebo), safety/efficacy study EudraCT: 2009-017525-19 [IE]
Abatacept Psoriatic Arthritis Active 20 Adt Sen
Mar-10 N/K St Vincent Univeristy Hospital
https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-017525-19/IE
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HUmira in Psoriatic Arthritis Phase IV: Single group assignment, efficacy study NCT01465438
Adalimumab Psoriatic Arthritis Comp 42 Adt Sen
Nov-06 Jun-11 Glostrup University Hospital, Copenhagen; University Hospital, Gentofte, Copenhagen; Copenhagen University Hospital at Herlev; Copenhagen University Hospital, Hvidovre
http://ClinicalTrials.gov/show/NCT01465438
AMG 827 in Subjects With Psoriatic Arthritis Phase II: RCT (placebo), safety/efficacy study NCT01516957
AMG 827; Placebo; AMG 827
Psoriatic Arthritis Rec 156 Adt Sen
Oct-11 Dec-17 Amgen http://ClinicalTrials.gov/show/NCT01516957
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy Phase II: RCT (placebo), safety/efficacy study NCT01490450
Placebo; BMS-945429
Arthritis, Psoriatic
Rec 150 Adt Sen
Dec-11 Dec-14 Bristol-Myers Squibb
http://ClinicalTrials.gov/show/NCT01490450
Phase 3, multicenter, randomized, double blind, parallel group, placebo controlled study to evaluate the efficacy and safety of certolizumab pegol in subjects with adult onset active and progressive psoriatic arthritis (psa) RCT (placebo), safety/efficacy study EudraCT 2009-011720-59 [FR; DE; ES; GB; BE; HU;NL;CZ; IE; IT]
Certolizumab pegol (CZP)
Psoriatic arthritis Active 600 Adt Sen
Apr-10 N/K Schwarz Biosciences
GB record https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011720-59/GB For other records via https://www.clinicaltrialsregister.eu/ctr-search
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A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis Phase III: RCT (active), safety/efficacy Study NCT01519089
CP-690,550 Psoriasis; Arthritis, Psoriatic
Not yet Rec
88 Adt Sen
Mar-12 Mar-14 Pfizer http://ClinicalTrials.gov/show/NCT01519089
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis Phase II/III: Single group assignment, safety study NCT01421069
Etanercept Juvenile Idiopahtic Arthritis
Not yet Rec
100 Child Adt Sen
Oct-11 Jan-21 Pfizer http://ClinicalTrials.gov/show/NCT01421069
Febuxostat versus Allopurinol Streamlined Trial (FAST) RCT (active), efficacy study ISRCTN72443728
Febuxostat; Allopurinol
Gout plus further cardiovascular risk including Inflammatory arthritis (e.g. RA, psoriatic arthritis, ankylosing spondylitis)
Active 5706 Adt Sen
Sep-11 Sep-16 University of Dundee (UK)
http://www.controlled-trials.com/ISRCTN72443728/
Self monitoring of methotrexate by patients with arthritis RCT (active), efficacy study ISRCTN21613721
Methotrexate self-monitoring; Methotrexate usual care
Rheumatoid arthritis; Psoriatic arthritis
Active 150 Adt Sen
Feb-10 Jun-12 Joint UCLH and UCL Biomedical Research Unit (UK)
http://www.controlled-trials.com/ISRCTN21613721
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA) Phase III: RCT (placebo), safety/efficacy study NCT01392326
Secukinumab (75 mg); Secukinumab (150 mg); Placebo
Psoriatic Arthritis Rec 600 Adt Sen
Jul-11 Jul-14 Novartis Pharmaceuticals
http://ClinicalTrials.gov/show/NCT01392326
15
A Study to Investigate the Use of Simponi® in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) Prospective cohort study NCT01313858
Simponi® Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing
Rec 1500 Adt Sen
Apr-10 Dec-14 Schering-Plough http://ClinicalTrials.gov/show/NCT01313858
Miscellaneous observational studies
Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis Prospective NCT01474876
Ankylosing Spondylitis; Psoriatic Arthritis
Rec 800 Adt Sen
Nov-11 Nov-13 Abbott http://ClinicalTrials.gov/show/NCT01474876
Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment Prospective case only study NCT01316224
Psoriasis; Psoriatic Arthritis
Rec 177 Adt Sen
Apr-11 Apr-13 Abbott http://ClinicalTrials.gov/show/NCT01316224
An immonohistochemical and molecular investigation of D6 and psoriasis UKCRN ID 11108
Psoriasis; psoriatic arthritis; atopic eczema; benign skin lesions
Active 200 Adt Sen
N/K Jan-13 NHS Greater Glasgow & Clyde
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11108
The CORRONA Data Collection Program Prospective cohort study NCT01402661
Rheumatoid Arthritis; Psoriatic Arthritis; Other Rheumatic Conditions
Invite 33312
Adt Sen
Feb-02 Aug-11 The Consortium of Rheumatology Researchers of North America, Inc.; University of Massachusetts, Worcester; University of Alabama at Birmingham; Brigham and Women's Hospital
http://ClinicalTrials.gov/show/NCT01402661
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A3: REACTIVE ARTHRITIS
No new records identified
A4: OTHER SPONDYLOARTHROPATHIES
Title Phases: study design (control) CT ID
Interventions Conditions Recruit n Age Grp
Start Date
End Date
Sponsors URL
Drugs including biologics
Safety of Etoricoxib (Mk-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082) Retrospective cohort study NCT01327638
Etoricoxib; Other COX-2 inhibitor; nsNSAIDs
Spondyl-arthropathies; Spondylitis, Ankylosing
Active, NR
16671
Child Adt Sen
Feb-11 Jun-14 Merck; Lund University
http://ClinicalTrials.gov/show/NCT01327638
Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria Phase III: RCT (placebo), safety/efficacy study NCT01426815
Placebo; Golimumab
Peripheral Spondylarthritis
Not yet Rec
60 Adt Sen
Nov-11 Nov-13 University Hospital, Ghent; Janssen Biologics B.V.
http://ClinicalTrials.gov/show/NCT01426815
Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis. RCT (placebo), proof of concept study NTR2834
Nilotinib; Placebo
Spondyloarthritis Active 30 Adt May-11 May-12
Academic Medical Center (The Netherlands)
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2834
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Miscellaneous observational studies
Ankylosing Spondylitis and Spondyloarthritis Evaluation Tool Study Prospective NCT01302730
Ankylosing Spondylitis; Spondylarthritis
Not yet Rec
400 Adt Sen
Apr-11 Dec-14 Stanford University; University of California, San Francisco; Oregon Health and Science University; Cedars-Sinai Medical Center
http://ClinicalTrials.gov/show/NCT01302730
The prevalence of inflammatory back pain and SpondyloArthropathies in a primary care population in Norfolk Cross-sectional cohort study ISRCTN76873217
Ankylosing spondylitis; Axial spondyloarthropathy
Ongoing 1000 Adt Sen
Sep-11 Jul-12 University of East Anglia (UK)
http://www.controlled-trials.com/ISRCTN76873217/
Biomarkers in chronic inflammatory arthritic diseases. NTR2832
Rheumatoid arthritis, Spondyloarthritis
Active 300 Adt Sen
Oct-10 Apr-12 Academic Medical Center (The Netherlands)
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2832
Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort Prospective cohort study NCT01314547
Spondylarthritis; Primary Systemic Vasculitis
Rec 300 Adt Sen
Mar-05 Dec-11 Assistance Publique - Hôpitaux de Paris
http://ClinicalTrials.gov/show/NCT01314547
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Inpatient of Sub-acute rehabilitation hospital) UMIN000006561
Variety of conditions including Spondylitis deformans
Comp 22 Adt Sen
Sep-10 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006966&language=E
18
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient of Sub-acute rehabilitation hospital) UMIN000006560
Variety of conditions including Spondylitis deformans
Comp 15 Adt Sen
Jan-10 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006964&language=E
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Out patient of Geriatric Health Services Facility) UMIN000006564
Variety of conditions including Spondylitis deformans
Comp 16 Adt Sen
Dec-09 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006967&language=E
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient rehabilitation facilities) UMIN000006563
Variety of conditions including Spondylitis deformans
Comp 12 Sen Sep-09 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006965&language=E
Natural History and Development of Spondyloarthritis Prospective NCT01422694
Arthritis; Spondylitis, Ankylosing
Rec 200 Child Adt Sen
Aug-11 Jul-11 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
http://ClinicalTrials.gov/show/NCT01422694
19
Brain activity Measurement at performing motivative exercise and passive exercise by functional magnetic resonance imaging UMIN000006559
Variety of conditions including Spondylitis deformans
Comp 14 Adt Sen
Apr-10 Aug-10 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006962&language=E
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Geriatric Health Services Facility) UMIN000006565
Variety of conditions including Spondylitis deformans
Comp 12 Sen Oct-09 Aug-10 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006968&language=E
Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Inpatient of Geriatric Health Services Facility) UMIN000006566
Variety of conditions including Spondylitis deformans
Comp 12 Adt Sen
Nov-09 Dec-09 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006969&language=E
Brain activation evaluation of the motivative exercise and passive exercise by comparing the fMRI results to the fNIRS results UMIN000006562
Variety of conditions including Spondylitis deformans
Comp 14 Adt Sen
Sep-08 Aug-09 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000006963&language=E