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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



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A3: Reactive arthritis ……………………………………………………………………………….. 16

A4: Other spondyloarthropathies ………………………………………………………….. 16



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

http://clinicaltrials.gov/show/NCT01351311


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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


Rec 40 Adt Sen

Sep-11 May-12 Diakonhjemmet Hospital; University of Oslo


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








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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


Comp 24 Adt Feb-11 Jan-12 All India Institute of Medical Sciences, New Delhi


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)


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


Active 84 Adt Sen

Jul-09 N/K Wyeth Lederle https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003096-39/IT







https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-003096-39/IT

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


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


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


Rec 10 Adult Jan-11 Dec-13 Shandong University


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


Active, NR

30 ChildAdt

Nov-11 Nov-12 Sun Yat-sen University








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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


Rec 348 Adt Sen

Jul-11 Jul-14 Novartis Pharmaceuticals


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


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


Procedures

Clinical study of Mecenchymal Stem Cells transplantation in Ankylosing Spondylitis ChiCTR-TRC-11001417

Mecenchymal Stem Cells transplantation


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


Active NR

88 Adt Jan-11 N/K Jiangsu Provincial Hospital of Traditional Chinese Medicine (China)


Integrated Traditional Chinese and Western medicine for ankylosing spondylitis ChiCTR-TRC-10001274

Integrated TCM and Western medicine


Rec 480 Adt Apr-10 N/K Development and Reform Commission of Guangdong Province (China)


Miscellaneous observational studies

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis Prospective cohort study NCT01387802


Rec 1120 Adt Sen

Jul-11 Jul-15 Abbott; JSS Medical Research Inc.; CATO Research Canada


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


Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation) Prospective cohort study NCT01329380



Nov-10 Dec-14 Abbott http://ClinicalTrials.gov/show/NCT01329380








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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


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)


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








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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


Aug-11 Jul-11 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Research of genetic gene and immune state in Ankylosing Spondylitis ChiCTR-OCC-11001565


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



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)



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


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


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




https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011720-59/GB

https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011720-59/GB

https://www.clinicaltrialsregister.eu/ctr-search

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)


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)


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









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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


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








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A3: REACTIVE ARTHRITIS

No new records identified

A4: OTHER SPONDYLOARTHROPATHIES



Start Date

End Date

Sponsors URL


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


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.


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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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


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)


Biomarkers in chronic inflammatory arthritic diseases. NTR2832

Rheumatoid arthritis, Spondyloarthritis

Active 300 Adt Sen

Oct-10 Apr-12 Academic Medical Center (The Netherlands)


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


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




http://www.trialregister.nl/trialreg/admin/rctsearch.asp?DC=70










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Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient of Sub-acute rehabilitation hospital) UMIN000006560


Comp 15 Adt Sen

Jan-10 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Out patient of Geriatric Health Services Facility) UMIN000006564


Comp 16 Adt Sen

Dec-09 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Outpatient rehabilitation facilities) UMIN000006563


Comp 12 Sen Sep-09 Aug-11 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


Natural History and Development of Spondyloarthritis Prospective NCT01422694

Arthritis; Spondylitis, Ankylosing


Aug-11 Jul-11 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)















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Brain activity Measurement at performing motivative exercise and passive exercise by functional magnetic resonance imaging UMIN000006559


Comp 14 Adt Sen

Apr-10 Aug-10 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Geriatric Health Services Facility) UMIN000006565


Comp 12 Sen Oct-09 Aug-10 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


Brain activity measurement at performing motivative exercise and passive exercise by Functional Near-Infrared Spectroscopy (Inpatient of Geriatric Health Services Facility) UMIN000006566


Comp 12 Adt Sen

Nov-09 Dec-09 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


Brain activation evaluation of the motivative exercise and passive exercise by comparing the fMRI results to the fNIRS results UMIN000006562


Comp 14 Adt Sen

Sep-08 Aug-09 Biophilia Institute, designated Institute by the Ministry of Education, Culture, Sports, Science and Technology (Japan)


















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