horizon scanning spondyloarthropathies first annual update ... spondylarthropathies,...

Download HORIZON SCANNING SPONDYLOARTHROPATHIES FIRST ANNUAL UPDATE ... spondylarthropathies, spondyloarthritis,

If you can't read please download the document

Post on 27-Jun-2020




0 download

Embed Size (px)


  • 1

    Written by Nadia Corp for: © Arthritis Research UK 2012


    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.





    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

  • 2

    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.

  • 3


    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.


    Adt Adult (18-65 years) CAM Complementary and Alternative Medicine Child Child (65 years) SLE Systemic Lupus Erythematosus Term Terminated

  • 4

    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


    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 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



    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_r esult_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://www.controlled-trials.com/ISRCTN91433175 http://www.controlled-t


View more >